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QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QVA149

Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed
Male or female adults aged ≥40 years
Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
Patients taking stable COPD medication (at least 60 days) prior to day 28
Patients with an mMRC grade of at least 2 at day 28

Exclusion Criteria:

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Patients with Type I or uncontrolled Type II diabetes
Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened
Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)
Patients who have a clinically significant laboratory abnormality at screening
Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate < 100/min. At screening the atrial fibrillation must be confirmed by central reading
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication
Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered
Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening
Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
Patients who have had a respiratory tract infection within 4 weeks prior to screening
Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
Patients requiring long term oxygen therapy prescribed for >12 hours per day
Patients with any history of asthma
Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
Patients with a blood eosinophil count > 600/mm3 at screening
Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)
Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)
Patients with clinically significant bronchiectasis
Patients with a diagnosis of α-1 anti-trypsin deficiency
Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active
Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)
Patients receiving any medications in the classes listed in the protocol
Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program
Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer
Patients unable to use an electronic patient diary and EXACT pro diary
Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

Arm Description

QVA149 (110/50 μg) once daily

Salmeterol/fluticasone (50/500μg) b.i.d

Outcomes

Primary Outcome Measures

Rate of COPD Exacerbations

COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.

Secondary Outcome Measures

Time to First COPD Exacerbation.

First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.

Rate of Moderate to Severe COPD Exacerbations.

COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

Time to First Moderate to Severe COPD Exacerbation.

Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .

Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.

All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.

Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.

Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization

Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

Forced Expiratory Volume in 1 Second

Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

Forced Expiratory Volume in 1 Second

Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

Forced Expiratory Volume in 1 Second

Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)

Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time"

Change From Baseline in Total St. George's Respiratory Questionnaire Score

The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Change From Baseline in the Number of Puffs of Rescue Medication

A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.

Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.

Urine cortisol/creatinine ratio

Change From Baseline in Forced Vital Capacity

Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction

Number of Patients With Adverse Events, Serious Adverse Events, and Death

The overall rate of adverse events reported from initiation through 30 days post last dose.

Full Information

NCT ID

NCT01782326

First Posted

January 30, 2013

Last Updated

May 5, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01782326

Brief Title

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

Official Title

A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

3362 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

QVA149 (110/50 μg) once daily

Arm Title

Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

Arm Type

Active Comparator

Arm Description

Salmeterol/fluticasone (50/500μg) b.i.d

Intervention Type

Drug

Intervention Name(s)

QVA149

Intervention Description

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.

Intervention Type

Drug

Intervention Name(s)

Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

Intervention Description

Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Primary Outcome Measure Information:

Title

Rate of COPD Exacerbations

Description

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Time to First COPD Exacerbation.

Description

Time Frame

52 weeks

Title

Rate of Moderate to Severe COPD Exacerbations.

Description

Time Frame

52 weeks

Title

Time to First Moderate to Severe COPD Exacerbation.

Description

Time Frame

52 weeks.

Title

Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

Description

COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

Time Frame

52 weeks

Title

Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

Description

Time Frame

52 weeks

Title

Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.

Description

Time Frame

52 weeks

Title

Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

Description

Time Frame

52 weeks

Title

Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

Description

Time Frame

52 weeks

Title

Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

Description

Time Frame

52 weeks

Title

Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization

Description

Time Frame

52 weeks

Title

Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

Description

Time Frame

52 weeks

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, day 1 (30 min and one hour post dose)

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, 4 weeks

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, 12 weeks

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, 26 weeks

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, 38 weeks

Title

Forced Expiratory Volume in 1 Second

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Description

Time Frame

Baseline, 4 weeks

Title

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Description

Time Frame

Baseline, 26 weeks

Title

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Description

Time Frame

Baseline, 38 weeks

Title

Change From Baseline in Total St. George's Respiratory Questionnaire Score

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline in the Number of Puffs of Rescue Medication

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.

Description

Urine cortisol/creatinine ratio

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in Forced Vital Capacity

Description

Time Frame

4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks

Title

Number of Patients With Adverse Events, Serious Adverse Events, and Death

Description

The overall rate of adverse events reported from initiation through 30 days post last dose.

Time Frame

52 weeks of treatment + 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed Male or female adults aged ≥40 years Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011) Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol) A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics Patients taking stable COPD medication (at least 60 days) prior to day 28 Patients with an mMRC grade of at least 2 at day 28 Exclusion Criteria: Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential Patients with Type I or uncontrolled Type II diabetes Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened) Patients who have a clinically significant laboratory abnormality at screening Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate < 100/min. At screening the atrial fibrillation must be confirmed by central reading Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation Patients who have had a respiratory tract infection within 4 weeks prior to screening Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection Patients requiring long term oxygen therapy prescribed for >12 hours per day Patients with any history of asthma Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years Patients with a blood eosinophil count > 600/mm3 at screening Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted) Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension) Patients with clinically significant bronchiectasis Patients with a diagnosis of α-1 anti-trypsin deficiency Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.) Patients receiving any medications in the classes listed in the protocol Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer Patients unable to use an electronic patient diary and EXACT pro diary Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1122

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1424BSF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Lanus

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

C1028AAP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Concepcion del Uruguay

State/Province

Entre Ríos

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000AII

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IFL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1120AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

C1425AUA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

M5500CBA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Feldbach

ZIP/Postal Code

8330

Country

Austria

Facility Name

Novartis Investigative Site

City

Feldkirch

ZIP/Postal Code

6800

Country

Austria

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Grieskirchen

ZIP/Postal Code

4710

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Thalheim bei Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1230

Country

Austria

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Gosselies

State/Province

BEL

ZIP/Postal Code

6041

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

State/Province

Limburg

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Luxembourg

ZIP/Postal Code

1210

Country

Belgium

Facility Name

Novartis Investigative Site

City

Oostende

ZIP/Postal Code

8400

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wavre

ZIP/Postal Code

1301

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Troyan

ZIP/Postal Code

5600

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4n1

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Novartis Investigative Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1G 1A7

Country

Canada

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Novartis Investigative Site

City

Downsview

State/Province

Ontario

ZIP/Postal Code

M3N 2Z9

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Novartis Investigative Site

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Charles-Borromée

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1N 4V3

Country

Canada

Facility Name

Novartis Investigative Site

City

Quillota

ZIP/Postal Code

2260877

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8910131

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

Country

Chile

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100023

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Guang Zhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Novartis Investigative Site

City

Haikou

State/Province

Hainan

ZIP/Postal Code

570311

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410003

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Shengyang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Novartis Investigative Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

Novartis Investigative Site

City

Guang Zhou

ZIP/Postal Code

510010

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Novartis Investigative Site

City

Floridablanca

State/Province

Santander

ZIP/Postal Code

57-7

Country

Colombia

Facility Name

Novartis Investigative Site

City

Armenia

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

Facility Name

Novartis Investigative Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Benesov

ZIP/Postal Code

256 30

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Cesky Krumlov

ZIP/Postal Code

381 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Cvikov

ZIP/Postal Code

471 54

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec III

ZIP/Postal Code

377 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Liberec

ZIP/Postal Code

460 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Melnik

ZIP/Postal Code

267 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Ostrava - Hrabuvka

ZIP/Postal Code

70030

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Ostrava

ZIP/Postal Code

708 68

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

530 09

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Prague 4

ZIP/Postal Code

142 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

108 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

158 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 6 - Repy

ZIP/Postal Code

163 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 6

ZIP/Postal Code

169 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Strakonice

ZIP/Postal Code

38601

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Teplice

ZIP/Postal Code

415 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Zatec

ZIP/Postal Code

438 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

DK-2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hellerup

ZIP/Postal Code

DK-2900

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hvidovre

ZIP/Postal Code

DK-2650

Country

Denmark

Facility Name

Novartis Investigative Site

City

Næstved

ZIP/Postal Code

4700

Country

Denmark

Facility Name

Novartis Investigative Site

City

Roskilde

ZIP/Postal Code

DK-4000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

Novartis Investigative Site

City

Sønderborg

ZIP/Postal Code

DK-6400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Århus

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13619

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Novartis Investigative Site

City

HUS

ZIP/Postal Code

00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Jyvaskyla

ZIP/Postal Code

40100

Country

Finland

Facility Name

Novartis Investigative Site

City

Kuopio

ZIP/Postal Code

FIN-70211

Country

Finland

Facility Name

Novartis Investigative Site

City

Pori

ZIP/Postal Code

FIN-28500

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20100

Country

Finland

Facility Name

Novartis Investigative Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

Novartis Investigative Site

City

Beuvry

ZIP/Postal Code

62660

Country

France

Facility Name

Novartis Investigative Site

City

Briis Sous Forges

ZIP/Postal Code

91640

Country

France

Facility Name

Novartis Investigative Site

City

Cournonterral

ZIP/Postal Code

34660

Country

France

Facility Name

Novartis Investigative Site

City

Lyon cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44300

Country

France

Facility Name

Novartis Investigative Site

City

Nimes Cedex

ZIP/Postal Code

30029

Country

France

Facility Name

Novartis Investigative Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

St Genis des Fontaines

ZIP/Postal Code

66740

Country

France

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

Novartis Investigative Site

City

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

NRW

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Cottbus

State/Province

Sachsen

ZIP/Postal Code

03050

Country

Germany

Facility Name

Novartis Investigative Site

City

Geesthacht

State/Province

Schleswig Holstein

ZIP/Postal Code

12502

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Woerishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12043

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12099

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13086

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13581

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33617

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53119

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Delitzsch

ZIP/Postal Code

04509

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47057

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Freudenberg

ZIP/Postal Code

57258

Country

Germany

Facility Name

Novartis Investigative Site

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

59065

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06108

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover Münden

ZIP/Postal Code

34346

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51069

Country

Germany

Facility Name

Novartis Investigative Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23558

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32423

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

80335

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Novartis Investigative Site

City

Neumünster

ZIP/Postal Code

24534

Country

Germany

Facility Name

Novartis Investigative Site

City

Oranienburg

ZIP/Postal Code

16515

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Novartis Investigative Site

City

Prien a. Chiemsee

ZIP/Postal Code

83209

Country

Germany

Facility Name

Novartis Investigative Site

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Schleswig

ZIP/Postal Code

24837

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwabach

ZIP/Postal Code

91126

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42651

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21680

Country

Germany

Facility Name

Novartis Investigative Site

City

Teuchern

ZIP/Postal Code

06682

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Warendorf

ZIP/Postal Code

48231

Country

Germany

Facility Name

Novartis Investigative Site

City

Weinheim

ZIP/Postal Code

69469

Country

Germany

Facility Name

Novartis Investigative Site

City

Wissen

ZIP/Postal Code

57537

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Rethymno

State/Province

ZIP/Postal Code

741 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 03

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

GR 711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Serres

ZIP/Postal Code

GR 62 100

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Ciudad

State/Province

Gautemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Kowloon

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Novartis Investigative Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Reykjavik

ZIP/Postal Code

IS-109

Country

Iceland

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500004

Country

India

Facility Name

Novartis Investigative Site

City

Vijayawada

State/Province

Andhra Pradesh

ZIP/Postal Code

520 002

Country

India

Facility Name

Novartis Investigative Site

City

Vishakhapatnam

State/Province

Andhra Pradesh

ZIP/Postal Code

530002

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 008

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 060

Country

India

Facility Name

Novartis Investigative Site

City

Gurgaon

State/Province

Haryana

ZIP/Postal Code

122 002

Country

India

Facility Name

Novartis Investigative Site

City

Manipal

State/Province

Karnataka

ZIP/Postal Code

576 104

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

400 012

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440010

Country

India

Facility Name

Novartis Investigative Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

641037

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 045.

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641037

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamilnadu

ZIP/Postal Code

641 018

Country

India

Facility Name

Novartis Investigative Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700 107

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

ZIP/Postal Code

560 034

Country

India

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60020

Country

Italy

Facility Name

Novartis Investigative Site

City

Cassano delle Murge

State/Province

ZIP/Postal Code

70020

Country

Italy

Facility Name

Novartis Investigative Site

City

Crema

State/Province

ZIP/Postal Code

26013

Country

Italy

Facility Name

Novartis Investigative Site

City

Foggia

State/Province

ZIP/Postal Code

71100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50100

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavullo nel Frignano

State/Province

ZIP/Postal Code

41026

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Cittadella

State/Province

ZIP/Postal Code

35013

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pordenone

State/Province

ZIP/Postal Code

33170

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Cuasso al Monte

State/Province

ZIP/Postal Code

21050

Country

Italy

Facility Name

Novartis Investigative Site

City

Tradate

State/Province

ZIP/Postal Code

21049

Country

Italy

Facility Name

Novartis Investigative Site

City

Negrar

State/Province

ZIP/Postal Code

37024

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Komaki-city

State/Province

Aichi

ZIP/Postal Code

485-0041

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Seto-city

State/Province

Aichi

ZIP/Postal Code

489-8642

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyoake-city

State/Province

Aichi

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Novartis Investigative Site

City

Yanagawa-city

State/Province

Fukuoka

ZIP/Postal Code

832-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Asahikawa-city

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

062-8618

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji-city

State/Province

Hyogo

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakaide-city

State/Province

Kagawa

ZIP/Postal Code

762-8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Takamatsu

State/Province

Kagawa

ZIP/Postal Code

760-8538

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

210-0852

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshi-city

State/Province

Kumamoto

ZIP/Postal Code

861-1196

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-city

State/Province

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsusaka-city

State/Province

Mie

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada-city

State/Province

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshigaya-city

State/Province

Saitama

ZIP/Postal Code

343-0851

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

430-8525

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

434-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Iwata

State/Province

Shizuoka

ZIP/Postal Code

438-8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Kiyose-city

State/Province

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Meguro

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

812-0033

Country

Japan

Facility Name

Novartis Investigative Site

City

Kochi

ZIP/Postal Code

780-8077

Country

Japan

Facility Name

Novartis Investigative Site

City

Bucheon-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Jeonju-si

State/Province

Jeollabuk-do

ZIP/Postal Code

561-712

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

130-709

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

403-720

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

130-872

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

156-755

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

ZIP/Postal Code

01117

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Alytus

ZIP/Postal Code

LT-62114

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-45130

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

06122

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Novartis Investigative Site

City

México

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara Jalisco

State/Province

Jalisco

ZIP/Postal Code

44220

Country

Mexico

Facility Name

Novartis Investigative Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico D.F.

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Novartis Investigative Site

City

Puebla

ZIP/Postal Code

72000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Almelo

ZIP/Postal Code

7609 PP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Assen

ZIP/Postal Code

9401 RK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7513 ER

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Geldrop

ZIP/Postal Code

5664 EH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Harderwijk

ZIP/Postal Code

3840 AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zutphen

ZIP/Postal Code

7207 AE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Follebu

ZIP/Postal Code

2656

Country

Norway

Facility Name

Novartis Investigative Site

City

Hønefoss

ZIP/Postal Code

3515

Country

Norway

Facility Name

Novartis Investigative Site

City

Kløfta

ZIP/Postal Code

2040

Country

Norway

Facility Name

Novartis Investigative Site

City

Kongsvinger

ZIP/Postal Code

2212

Country

Norway

Facility Name

Novartis Investigative Site

City

Skedsmokorset

ZIP/Postal Code

2020

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Novartis Investigative Site

City

Svelvik

ZIP/Postal Code

3060

Country

Norway

Facility Name

Novartis Investigative Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Novartis Investigative Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Pila

ZIP/Postal Code

64-920

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Novartis Investigative Site

City

Almada

ZIP/Postal Code

2801-951

Country

Portugal

Facility Name

Novartis Investigative Site

City

Barcelos

ZIP/Postal Code

4754-909

Country

Portugal

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3041-853

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1169-024

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Torres Vedras

ZIP/Postal Code

2560-324

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Franca de Xira

ZIP/Postal Code

2600-009

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Nova de Gaia

ZIP/Postal Code

4434-502

Country

Portugal

Facility Name

Novartis Investigative Site

City

Viseu

ZIP/Postal Code

3504-509

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucuresti

State/Province

District 1

ZIP/Postal Code

10457

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200515

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300310

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310013

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310086

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500086

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

060011

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

50159

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330084

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330162

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

ZIP/Postal Code

700305

Country

Romania

Facility Name

Novartis Investigative Site

City

Oradea

ZIP/Postal Code

410051

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

ZIP/Postal Code

540072

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

N.Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov-on-Don

ZIP/Postal Code

344090

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tver

ZIP/Postal Code

170100

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa

ZIP/Postal Code

450000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Novartis Investigative Site

City

Knez Selo

ZIP/Postal Code

18204

Country

Serbia

Facility Name

Novartis Investigative Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bojnice

State/Province

Slovak Republic

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Humenné

State/Province

Slovak republic

ZIP/Postal Code

066 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak republic

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

State/Province

Slovak Republic

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Partizanske

State/Province

Slovak Republic

ZIP/Postal Code

958 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Námestovo

State/Province

Slovensko

ZIP/Postal Code

02901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

84104

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Lucenec

ZIP/Postal Code

98439

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nove Zamky

ZIP/Postal Code

940 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Povazska Bystrica

ZIP/Postal Code

017 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisská Nová Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Berea

State/Province

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Sandton

State/Province

Gauteng

ZIP/Postal Code

2057

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7531

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Gatesville

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Novartis Investigative Site

City

Port Elizabeth

ZIP/Postal Code

6014

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0132

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sanlucar de Barrameda

State/Province

Andalucia

ZIP/Postal Code

11540

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Torrelavega

State/Province

Cantabria

ZIP/Postal Code

39300

Country

Spain

Facility Name

Novartis Investigative Site

City

Burgos

State/Province

Castilla y Leon

ZIP/Postal Code

09006

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

State/Province

Castilla y Leon

ZIP/Postal Code

24400

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla y Leon

ZIP/Postal Code

47011

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08026

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08024

Country

Spain

Facility Name

Novartis Investigative Site

City

Salt

State/Province

Cataluña

ZIP/Postal Code

17190

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03550

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Comunidad Valenciana

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Merida

State/Province

Extremadura

ZIP/Postal Code

06800

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcón

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Cartagena

State/Province

Murcia

ZIP/Postal Code

30202

Country

Spain

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Boras

ZIP/Postal Code

506 30

Country

Sweden

Facility Name

Novartis Investigative Site

City

Luleå

ZIP/Postal Code

SE-971 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

111 57

Country

Sweden

Facility Name

Novartis Investigative Site

City

Trollhattan

ZIP/Postal Code

461 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uddevalla

ZIP/Postal Code

451 50

Country

Sweden

Facility Name

Novartis Investigative Site

City

Tainan 704

State/Province

Taiwan ROC

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Chiayi County

ZIP/Postal Code

613

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Niaosong Township

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei County

ZIP/Postal Code

22060

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34854

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kinikli / Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Manisa

ZIP/Postal Code

45040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

Huntingdon

State/Province

Cambridgeshire

ZIP/Postal Code

PE29 6NT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

Cleveland

ZIP/Postal Code

TS19 8PE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Midsomer Norton

State/Province

Radstock

ZIP/Postal Code

BA3 2UH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Axbridge

State/Province

Somerset

ZIP/Postal Code

BS26 2BJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Taunton

State/Province

Somerset

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

South Shields

State/Province

Tyne and Wear

ZIP/Postal Code

NE34 0PL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Crawley

State/Province

West Sussex

ZIP/Postal Code

RH10 7DX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cambridge

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chester

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Darlington

ZIP/Postal Code

DL3 6HX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Lancashire

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC14 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Tyne & Wear

ZIP/Postal Code

NE29 8NH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wiltshire

ZIP/Postal Code

SN15 2SB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32321518

Citation

Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.

Results Reference

derived

PubMed Identifier

30621717

Citation

Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.

Results Reference

derived

PubMed Identifier

30019939

Citation

Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.

Results Reference

derived

PubMed Identifier

29925383

Citation

Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.

Results Reference

derived

PubMed Identifier

28278391

Citation

Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.

Results Reference

derived

PubMed Identifier

27181606

Citation

Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.

Results Reference

derived

Learn more about this trial

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

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QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial