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Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QVA149

NVA237

tiotropium

Salbutamol/albuterol

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring QVA149, NVA237, COPD, exacerbation, combination bronchodilator

Eligibility Criteria

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

Inclusion Criteria :

Male or female adults aged ≥40 years, who had signed an informed consent form prior to initiation of any study-related procedure.
Patients with severe to very severe Chronic Obstructive Pulmonary Disease COPD (Stage III or IV) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
Current or ex-smokers with a smoking history of at least 10 pack years (Ten pack-years were 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) <50% of the predicted normal value, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70 at Visit 2 (day -14). (Post refers to 1 h 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.

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Women of child-bearing potential
Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia.
Patients who had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 or between visit 1 (Day -21) and Visit 3 (Day 1).
Patients who developed a COPD exacerbation during a period between visit 1 and 3 were ineligible but were permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
Patients who had a respiratory tract infection within 4 weeks prior to visit 1 (Day -21)
• Patients who developed an upper or lower respiratory tract infection during the screening period (up to visit 3 (Day 1) were not eligible, but were permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
Patients with lung lobectomy, or lung volume reduction or lung transplantation.
Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
- Unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable Atrial Fibrillation (AF). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study
- history of malignancy of any organ system (including lung cancer), 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
- uncontrolled hypo- or hyperthyroidism, hypokalemia or hyper adrenergic state
- narrow-angle glaucoma
- Symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a Transurethral Resection of Prostate (TURP) were excluded from the study. Patients who underwent full re-section of the prostate could be considered for the study, as well as patients who were asymptomatic and stable on pharmacological treatment for the condition).
- any condition which might have compromised patient safety or compliance, interfered with evaluation, or precluded completion of the study
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 2), or onset of symptoms prior to 40 years. Patients without asthma were excluded if their eosinophil count was >600/mm3 at visit 2.
Patients with allergic rhinitis who used H1 antagonists or intranasal corticosteroids intermittently (treatment with a constant dose was permitted).
Patients with eczema (atopic), known high immunoglobulin E (IgE) levels or a known positive skin prick test in the last 5 years.
Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.
Patients who were participating in the active phase of a supervised pulmonary rehabilitation program.
Patients with Type I or uncontrolled Type II diabetes.
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or drugs of a similar class or any component thereof:
- anticholinergic agents
- long and short acting beta-2 agonists
- sympathomimetic amines.
Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at visit 2 (Day -14) (Fridericia method) was prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients could not be re-screened).
Patients who needed treatments for COPD and allied conditions after the start of the study (visit 1)
Patients who needed treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they had been stabilized
Patients taking other prohibited medications
Patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler (SDDPI), HandiHaler® device, or pressurized Metered Dose Inhaler (MDI) (rescue medication).
Patients unable to use an electronic patient diary.
Patients who were, in the opinion of the investigator known to be unreliable or non-compliant.
Patients who used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of visit 1 (day -21), whichever was longer.
Patients who had live attenuated vaccination within 30 days prior to the screening visit or during the run-in period. Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine was acceptable provided it was not administered within 48 hours prior to screening and randomization visits.

No additional exclusions were applied by the investigator, in order to ensure that the study population was representative of all eligible patients.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

NVA237

open-label tiotropium

Arm Description

QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.

NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.

Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.

Outcomes

Primary Outcome Measures

Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Secondary Outcome Measures

Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.

Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics

Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics

The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.

Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.

Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.

Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period

Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.

Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points

Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards. Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve. The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates.

Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards. Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis

Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period

The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.

Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period

A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment

St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.

Full Information

NCT ID

NCT01120691

First Posted

May 5, 2010

Last Updated

October 29, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01120691

Brief Title

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

Acronym

SPARK

Official Title

A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe 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

Keywords

QVA149, NVA237, COPD, exacerbation, combination bronchodilator

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

Arm Title

NVA237

Arm Type

Active Comparator

Arm Description

Arm Title

open-label tiotropium

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

QVA149

Intervention Description

Intervention Type

Drug

Intervention Name(s)

NVA237

Intervention Description

Intervention Type

Drug

Intervention Name(s)

tiotropium

Intervention Description

Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

Intervention Type

Drug

Intervention Name(s)

Salbutamol/albuterol

Intervention Description

As needed throughout the study

Primary Outcome Measure Information:

Title

Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.

Description

Time Frame

64 weeks

Secondary Outcome Measure Information:

Title

Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.

Description

Time Frame

76 weeks

Title

Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period

Description

Time Frame

64 weeks

Title

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics

Description

Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Time Frame

64 weeks

Title

Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics

Description

The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.

Time Frame

64 weeks

Title

Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.

Description

Time Frame

64 weeks

Title

Description

Time Frame

64 weeks

Title

Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points

Description

Time Frame

26, 52, 64, 76 weeks

Title

Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

Description

Time Frame

4, 12, 26, 38, 52 and 64 weeks

Title

Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

Description

Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards. Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis

Time Frame

4, 12, 26, 38, 52 and 64 weeks

Title

Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period

Description

Time Frame

Baseline (14 day run-in), 64 weeks

Title

Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period

Description

Time Frame

Baseline (14 day run-in), 64 weeks

Title

St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment

Description

Time Frame

12, 26, 38, 52 and 64 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Male or female adults aged ≥40 years, who had signed an informed consent form prior to initiation of any study-related procedure. Patients with severe to very severe Chronic Obstructive Pulmonary Disease COPD (Stage III or IV) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008. Current or ex-smokers with a smoking history of at least 10 pack years (Ten pack-years were 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) <50% of the predicted normal value, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70 at Visit 2 (day -14). (Post refers to 1 h 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. Exclusion Criteria: Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test). Women of child-bearing potential Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia. Patients who had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 or between visit 1 (Day -21) and Visit 3 (Day 1). Patients who developed a COPD exacerbation during a period between visit 1 and 3 were ineligible but were permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. Patients who had a respiratory tract infection within 4 weeks prior to visit 1 (Day -21) • Patients who developed an upper or lower respiratory tract infection during the screening period (up to visit 3 (Day 1) were not eligible, but were permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension. Patients with lung lobectomy, or lung volume reduction or lung transplantation. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): Unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable Atrial Fibrillation (AF). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study history of malignancy of any organ system (including lung cancer), 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 uncontrolled hypo- or hyperthyroidism, hypokalemia or hyper adrenergic state narrow-angle glaucoma Symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a Transurethral Resection of Prostate (TURP) were excluded from the study. Patients who underwent full re-section of the prostate could be considered for the study, as well as patients who were asymptomatic and stable on pharmacological treatment for the condition). any condition which might have compromised patient safety or compliance, interfered with evaluation, or precluded completion of the study Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 2), or onset of symptoms prior to 40 years. Patients without asthma were excluded if their eosinophil count was >600/mm3 at visit 2. Patients with allergic rhinitis who used H1 antagonists or intranasal corticosteroids intermittently (treatment with a constant dose was permitted). Patients with eczema (atopic), known high immunoglobulin E (IgE) levels or a known positive skin prick test in the last 5 years. Patients with known history and diagnosis of alpha-1 antitrypsin deficiency. Patients who were participating in the active phase of a supervised pulmonary rehabilitation program. Patients with Type I or uncontrolled Type II diabetes. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or drugs of a similar class or any component thereof: anticholinergic agents long and short acting beta-2 agonists sympathomimetic amines. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at visit 2 (Day -14) (Fridericia method) was prolonged (>450 ms for males and females) as confirmed by the central ECG assessor. Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients could not be re-screened). Patients who needed treatments for COPD and allied conditions after the start of the study (visit 1) Patients who needed treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they had been stabilized Patients taking other prohibited medications Patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler (SDDPI), HandiHaler® device, or pressurized Metered Dose Inhaler (MDI) (rescue medication). Patients unable to use an electronic patient diary. Patients who were, in the opinion of the investigator known to be unreliable or non-compliant. Patients who used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of visit 1 (day -21), whichever was longer. Patients who had live attenuated vaccination within 30 days prior to the screening visit or during the run-in period. Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine was acceptable provided it was not administered within 48 hours prior to screening and randomization visits. No additional exclusions were applied by the investigator, in order to ensure that the study population was representative of all eligible patients.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Novartis Investigative Site

City

Fairhope

State/Province

Alabama

ZIP/Postal Code

36532

Country

United States

Facility Name

Novartis Investigative Site

City

Florence

State/Province

Alabama

ZIP/Postal Code

35630

Country

United States

Facility Name

Novartis Investigative Site

City

Homewood

State/Province

Alabama

ZIP/Postal Code

35209-6870

Country

United States

Facility Name

Novartis Investigative Site

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Facility Name

Novartis Investigative Site

City

Pine Bluff

State/Province

Arkansas

ZIP/Postal Code

71603

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1207

Country

United States

Facility Name

Novartis Investigative Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92101

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103-8415

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

Novartis Investigative Site

City

Couer D'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Novartis Investigative Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Novartis Investigative Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Novartis Investigative Site

City

Florence

State/Province

Kentucky

ZIP/Postal Code

41042

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40206

Country

United States

Facility Name

Novartis Investigative Site

City

Opelousas

State/Province

Louisiana

ZIP/Postal Code

70570

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Novartis Investigative Site

City

Ozark

State/Province

Missouri

ZIP/Postal Code

65721

Country

United States

Facility Name

Novartis Investigative Site

City

St. Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59804

Country

United States

Facility Name

Novartis Investigative Site

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046

Country

United States

Facility Name

Novartis Investigative Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Novartis Investigative Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89520

Country

United States

Facility Name

Novartis Investigative Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Novartis Investigative Site

City

Massapequa

State/Province

New York

ZIP/Postal Code

11758

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Novartis Investigative Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504-8741

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Novartis Investigative Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406-7108

Country

United States

Facility Name

Novartis Investigative Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Novartis Investigative Site

City

Ft. Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Novartis Investigative Site

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novartis Investigative Site

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54311

Country

United States

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1424BSF

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

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

San Isidro

State/Province

Buenos Aires

ZIP/Postal Code

B1609EEO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

C2000DSR

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

T4000DGF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1428

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B1842DID

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos aires

ZIP/Postal Code

B1878FNR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos aires

ZIP/Postal Code

B2705XAE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B6500EZL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1013AAR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1115AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos aires

ZIP/Postal Code

C1120AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1186ACB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425AUA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425BEA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1440BRR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

3400

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

M5500CCG

Country

Argentina

Facility Name

Novartis Investigative Site

City

Paraná Entre Ríos

ZIP/Postal Code

3100

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Feldbach

ZIP/Postal Code

8330

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

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Novartis Investigative Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Joliette

State/Province

Quebec

ZIP/Postal Code

J6E 6J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7S 2M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Novartis Investigative Site

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1G 3Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Romuald

State/Province

Quebec

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1P 1J6

Country

Canada

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Novartis Investigative Site

City

Armenia

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogotá

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellin

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

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

Havlickuv Brod

ZIP/Postal Code

580 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Jaromer

ZIP/Postal Code

551 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Karlovy Vary

ZIP/Postal Code

360 66

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Kromeriz

ZIP/Postal Code

767 55

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Kutna Hora

ZIP/Postal Code

284 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Kyjov

ZIP/Postal Code

697 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

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 9

ZIP/Postal Code

198 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Rokycany

ZIP/Postal Code

337 22

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

Znojmo

ZIP/Postal Code

669 02

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK-9100

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

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

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

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

00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Jyvaskyla

ZIP/Postal Code

40100

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20100

Country

Finland

Facility Name

Novartis Investigative Site

City

Bayonne Cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Beuvry

ZIP/Postal Code

62660

Country

France

Facility Name

Novartis Investigative Site

City

Ferolles-Attily

ZIP/Postal Code

77150

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

NRW

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

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

10367

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

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

12165

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

14050

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

D-12165

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

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Dueren

ZIP/Postal Code

52349

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47057

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

Fulda

ZIP/Postal Code

36039

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Novartis Investigative Site

City

Gummersbach

ZIP/Postal Code

51643

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

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69117

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66424

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24148

Country

Germany

Facility Name

Novartis Investigative Site

City

Langenfeld

ZIP/Postal Code

40764

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

04357

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

Muenchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90419

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

Radebeul

ZIP/Postal Code

01445

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Saarbruecken

ZIP/Postal Code

66111

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerte

ZIP/Postal Code

58239

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwetzingen

ZIP/Postal Code

68723

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

Teterow

ZIP/Postal Code

17166

Country

Germany

Facility Name

Novartis Investigative Site

City

Wissen

ZIP/Postal Code

57537

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens - GR

ZIP/Postal Code

10676

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 12461

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR-106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR56403

Country

Greece

Facility Name

Novartis Investigative Site

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cegled

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Makó

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Sopron

ZIP/Postal Code

9400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

A.p.

ZIP/Postal Code

500 001

Country

India

Facility Name

Novartis Investigative Site

City

Hyderbabd

State/Province

Andhra Pradesh

ZIP/Postal Code

500 029

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570004

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422005

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 014

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302004

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 002

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641004

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641014

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur - Maharastra

ZIP/Postal Code

400 012

Country

India

Facility Name

Novartis Investigative Site

City

Panjim

ZIP/Postal Code

403002

Country

India

Facility Name

Novartis Investigative Site

City

Secunderabad

ZIP/Postal Code

500002

Country

India

Facility Name

Novartis Investigative Site

City

Trivandrum

ZIP/Postal Code

695011

Country

India

Facility Name

Novartis Investigative Site

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Dublin 15

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Ireland

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Novartis Investigative Site

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Dublin 24

Country

Ireland

Facility Name

Novartis Investigative Site

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Dublin 4

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin 9

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

Country

Ireland

Facility Name

Novartis Investigative Site

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Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Beer-Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar-Sava

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Osimo

State/Province

ZIP/Postal Code

60027

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95125

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

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Arenzano

State/Province

ZIP/Postal Code

16011

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20121

Country

Italy

Facility Name

Novartis Investigative Site

City

Abano Terme

State/Province

ZIP/Postal Code

35031

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Facility Name

Novartis Investigative Site

City

Riccione

State/Province

ZIP/Postal Code

47838

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pietra Ligure

State/Province

ZIP/Postal Code

17027

Country

Italy

Facility Name

Novartis Investigative Site

City

Montecchio Maggiore

State/Province

ZIP/Postal Code

36075

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Novartis Investigative Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64450

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis Potosí

ZIP/Postal Code

78218

Country

Mexico

Facility Name

Novartis Investigative Site

City

Almelo

ZIP/Postal Code

7609 PP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Dordrecht

ZIP/Postal Code

3318AT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Drachten

ZIP/Postal Code

9200 DA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7513 ER

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Harderwijk

ZIP/Postal Code

3840 AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Helmond

ZIP/Postal Code

5707 HA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoorn

ZIP/Postal Code

1624 NP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Roermond

ZIP/Postal Code

6043 CV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Voorburg

ZIP/Postal Code

2275 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Cercado de Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Borja

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Martin de Porres

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Miguel

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1109

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Las Pinas

ZIP/Postal Code

1740

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

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

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-067

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-637

Country

Poland

Facility Name

Novartis Investigative Site

City

Mrozy

ZIP/Postal Code

05-320

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

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01-456

Country

Poland

Facility Name

Novartis Investigative Site

City

Humacao

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00791

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Puerto Rico

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Novartis Investigative Site

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Kazan

State/Province

Tatarstan Republic

ZIP/Postal Code

420015

Country

Russian Federation

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

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127018

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

S.-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Samara

ZIP/Postal Code

443079

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sankt-Peterburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

191015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

198013

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.Petersburg

ZIP/Postal Code

198044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150010

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

Slovak Republic

ZIP/Postal Code

975 17

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

Humenne

State/Province

Slovak Republic

ZIP/Postal Code

066 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

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kralovsky Chlmec

ZIP/Postal Code

077 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

03601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Newtown, Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

Country

South Africa

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

L'Hospitalet de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

ZIP/Postal Code

03114

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

Cleveland

ZIP/Postal Code

TS19 8PE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sneinton

State/Province

Nottingham

ZIP/Postal Code

NG3 7DQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Taunton

State/Province

Somerset

ZIP/Postal Code

TA1 3JL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chertsey

State/Province

Surrey

ZIP/Postal Code

KT16 0PZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Coventry

ZIP/Postal Code

CV6 4DD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Gillingham

ZIP/Postal Code

ME7 5NY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G21 3UW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hereford

ZIP/Postal Code

HR1 2ER

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Huntingdon

ZIP/Postal Code

PE29 6NT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2PR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M23 9QZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Portsmouth

ZIP/Postal Code

PO6 3AD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Telford

ZIP/Postal Code

TF1 6TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24429126

Citation

Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

Results Reference

derived

Learn more about this trial

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

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Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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