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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Indacaterol acetate/Mometasone furoate

Mometasone furoate

Salmeterol xinafoate/fluticasone propionate

About this trial

This is an interventional treatment trial for Asthma focused on measuring QMF149, Mometasone furoate (MF), asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days
A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

Reversibility should be repeated once-
Participants may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
Alternatively, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
Participants who have ever required intubation for a severe asthma attack/exacerbation.
Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Participants with severe narcolepsy and/or insomnia.
Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once

Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

QMF149 150/160 µg

QMF149 150/320 µg

MF 400 µg

Salmeterol /fluticasone 50/500 μg

MF 800 μg

Arm Description

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.

QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.

Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening

Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.

MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26

Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

Secondary Outcome Measures

Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.

Trough FEV1 at Week 52

Pre-dose FEV1 at Weeks 4 and 12

Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

Post Dose FEV1 (5 Minutes-1 Hour)

Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

Trough Forced Vital Capacity (FVC)

FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.

Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)

FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.

Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment

PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.

Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52

Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions

Change From Baseline in Percentage of Asthma Symptoms Free Days

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.

Change Form Baseline in Percentage of Days With no Daytime Symptoms

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).

Change From Baseline in Percentage of Nights With no Night-time Awakenings

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).

Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems).

Rescue Medication Usage

All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use

Time to First Asthma Exacerbation by Exacerbation Category

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time to First Hospitalization for Asthma Exacerbation

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Annual Rate of Asthma Exacerbations by Exacerbation Category

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Duration in Days of Asthma Exacerbations by Exacerbation Category

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations

Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations

The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.

Change From Baseline in Percentage of Rescue Medication Free Days

All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.

Asthma Quality of Life Questionnaire (AQLQ)

AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains: Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items) Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items) Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items) Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items) Overall Score = Mean of Items 1 to 32 (32 items)

Trough FEV1 Measured After 26 Weeks of Treatment

Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes

A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention.

Full Information

NCT ID

NCT02554786

First Posted

September 9, 2015

Last Updated

February 21, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02554786

Brief Title

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

Official Title

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 29, 2015 (Actual)

Primary Completion Date

November 21, 2018 (Actual)

Study Completion Date

June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

6. Conditions and Keywords

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

Asthma

Keywords

QMF149, Mometasone furoate (MF), asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QMF149 150/160 µg

Arm Type

Experimental

Arm Description

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening.

Arm Title

QMF149 150/320 µg

Arm Type

Experimental

Arm Description

QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening.

Arm Title

MF 400 µg

Arm Type

Active Comparator

Arm Description

Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening

Arm Title

Salmeterol /fluticasone 50/500 μg

Arm Type

Active Comparator

Arm Description

Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.

Arm Title

MF 800 μg

Arm Type

Active Comparator

Arm Description

MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.

Intervention Type

Drug

Intervention Name(s)

Indacaterol acetate/Mometasone furoate

Other Intervention Name(s)

QMF149

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate

Intervention Type

Drug

Intervention Name(s)

Salmeterol xinafoate/fluticasone propionate

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26

Description

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52

Description

Time Frame

Weeks 4, 12, 26 and 52

Title

Trough FEV1 at Week 52

Description

Time Frame

Week 52

Title

Pre-dose FEV1 at Weeks 4 and 12

Description

Time Frame

Weeks 4 (Day 30) and 12 (Day 86)

Title

Post Dose FEV1 (5 Minutes-1 Hour)

Description

Time Frame

Up to Week 52 (Day 364)

Title

Trough Forced Vital Capacity (FVC)

Description

Time Frame

Up to Week 52 (Day 365)

Title

Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)

Description

Time Frame

Up to Week 52 (Day 365)

Title

Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment

Description

Time Frame

Up to Weeks 26 and 52

Title

Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52

Description

Time Frame

Weeks 26 (Day 183) and 52 (Day 364)

Title

Change From Baseline in Percentage of Asthma Symptoms Free Days

Description

Time Frame

Up to Week 52

Title

Change Form Baseline in Percentage of Days With no Daytime Symptoms

Description

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).

Time Frame

Up to Week 52

Title

Change From Baseline in Percentage of Nights With no Night-time Awakenings

Description

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).

Time Frame

Up to Week 52

Title

Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening

Description

All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems).

Time Frame

Up to Week 52

Title

Rescue Medication Usage

Description

Time Frame

Up to Weeks 26 and 52

Title

Time to First Asthma Exacerbation by Exacerbation Category

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Time to First Hospitalization for Asthma Exacerbation

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Annual Rate of Asthma Exacerbations by Exacerbation Category

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Duration in Days of Asthma Exacerbations by Exacerbation Category

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations

Description

The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.

Time Frame

Up to Week 52

Title

Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations

Time Frame

Up to Week 52

Title

Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations

Description

Time Frame

Up to Week 52

Title

Change From Baseline in Percentage of Rescue Medication Free Days

Description

Time Frame

Up to Weeks 26 and 52

Title

Asthma Quality of Life Questionnaire (AQLQ)

Description

Time Frame

Up to Week 52 (Day 364)

Title

Trough FEV1 Measured After 26 Weeks of Treatment

Description

Time Frame

Week 26

Title

Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes

Description

A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.

Time Frame

Up to Week 52

Title

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Description

Time Frame

Approximately up to 56 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening) Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1 Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102. Spacer devices are permitted for reversibility testing only. -Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101 If reversibility is not demonstrated at Visit 101: Reversibility should be repeated once- Participants may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1 Alternatively, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1. Exclusion Criteria: Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1 Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening) Participants who have ever required intubation for a severe asthma attack/exacerbation. Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study). Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. Participants with severe narcolepsy and/or insomnia. Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once). Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment. Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Novartis Investigative Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

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

92117

Country

United States

Facility Name

Novartis Investigative Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

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

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Novartis Investigative Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Novartis Investigative Site

City

Waldorf

State/Province

Maryland

ZIP/Postal Code

20602

Country

United States

Facility Name

Novartis Investigative Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747-3322

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123

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

Skillman

State/Province

New Jersey

ZIP/Postal Code

08558

Country

United States

Facility Name

Novartis Investigative Site

City

Cortland

State/Province

New York

ZIP/Postal Code

13045

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

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

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Novartis Investigative Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Novartis Investigative Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Novartis Investigative Site

City

Greenfield

State/Province

Wisconsin

ZIP/Postal Code

53228

Country

United States

Facility Name

Novartis Investigative Site

City

Plovdiv

State/Province

BGR

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

State/Province

BGR

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vidin

State/Province

BGR

ZIP/Postal Code

3703

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

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

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

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350025

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

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

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

Chang Chun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110000

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110003

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110011

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

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

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

ZIP/Postal Code

610083

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

510080

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

ZIP/Postal Code

510000

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

ZIP/Postal Code

510180

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200092

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Novartis Investigative Site

City

Varazdin

State/Province

HRV

ZIP/Postal Code

42000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

State/Province

HRV

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Petrinja

ZIP/Postal Code

44250

Country

Croatia

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zadar

ZIP/Postal Code

23000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Beroun

State/Province

Czech Republic

ZIP/Postal Code

266 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Boskovice

State/Province

Czech Republic

ZIP/Postal Code

680 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jablonec nad Nisou

State/Province

Czech Republic

ZIP/Postal Code

466 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec

State/Province

Czech Republic

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kurim

State/Province

Czech Republic

ZIP/Postal Code

66434

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

State/Province

Czech Republic

ZIP/Postal Code

14800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Varnsdorf

State/Province

Czech Republic

ZIP/Postal Code

40747

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

State/Province

CZE

ZIP/Postal Code

709 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

State/Province

CZE

ZIP/Postal Code

301 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Breclav

ZIP/Postal Code

690 02

Country

Czechia

Facility Name

Novartis Investigative Site

City

Cesky Krumlov

ZIP/Postal Code

381 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kutna Hora

ZIP/Postal Code

28401

Country

Czechia

Facility Name

Novartis Investigative Site

City

Novy Bor

ZIP/Postal Code

47301

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

323 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 8

ZIP/Postal Code

182 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Rokycany

ZIP/Postal Code

337 22

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tabor

ZIP/Postal Code

390 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

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

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Ahlen

ZIP/Postal Code

59229

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

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10247

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

10787

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

12157

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

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

12627

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13057

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

13187

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

D-44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Boehlen

ZIP/Postal Code

04564

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53119

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

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Dueren

ZIP/Postal Code

52349

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40211

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

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Furstenwalde

ZIP/Postal Code

15517

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

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22335

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novartis Investigative Site

City

Hochstadt

ZIP/Postal Code

91315

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

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

04109

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

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

D-35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuss

ZIP/Postal Code

41462

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

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Novartis Investigative Site

City

Rudersdorf

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

Schwedt

ZIP/Postal Code

16303

Country

Germany

Facility Name

Novartis Investigative Site

City

Weinheim

ZIP/Postal Code

69469

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Ciudad

State/Province

Gautemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01011

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

Guatemala City

ZIP/Postal Code

01057

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1037

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1117

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1204

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

State/Province

HUN

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hajdunanas

State/Province

HUN

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mako

State/Province

HUN

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

State/Province

HUN

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Novartis Investigative Site

City

Puspokladany

State/Province

HUN

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szazhalombatta

State/Province

HUN

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cegled

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Csorna

ZIP/Postal Code

H-9300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dombovar

ZIP/Postal Code

7200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosdos

ZIP/Postal Code

7257

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szigetvar

ZIP/Postal Code

7900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110007

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

380016

Country

India

Facility Name

Novartis Investigative Site

City

Vadodara

State/Province

Gujarat

ZIP/Postal Code

390021

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570001

Country

India

Facility Name

Novartis Investigative Site

City

Kozhikode

State/Province

Kerala

ZIP/Postal Code

673008

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400601

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440010

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440012

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440019

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411007

Country

India

Facility Name

Novartis Investigative Site

City

Mohali

State/Province

Punjab

ZIP/Postal Code

160 062

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302001

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302013

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302020

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302023

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Facility Name

Novartis Investigative Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Wilton

State/Province

Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

County Limerick

ZIP/Postal Code

V94 F858

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

DUBLIN 8

Country

Ireland

Facility Name

Novartis Investigative Site

City

Ichihara-city

State/Province

Chiba

ZIP/Postal Code

299-0111

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

819-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Kasuga-city

State/Province

Fukuoka

ZIP/Postal Code

816-0813

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

Obihiro-city

State/Province

Hokkaido

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji-city

State/Province

Hyogo

ZIP/Postal Code

671-0102

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

Naka-gun

State/Province

Ibaraki

ZIP/Postal Code

319-1113

Country

Japan

Facility Name

Novartis Investigative Site

City

Atsugi-city

State/Province

Kanagawa

ZIP/Postal Code

243-0034

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

255

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

232-0064

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

980-0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

702-8055

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

Osaka city

State/Province

Osaka

ZIP/Postal Code

530 0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Takatsuki-city

State/Province

Osaka

ZIP/Postal Code

569-1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyonaka-city

State/Province

Osaka

Country

Japan

Facility Name

Novartis Investigative Site

City

Yao-city

State/Province

Osaka

ZIP/Postal Code

581-0011

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshigaya-city

State/Province

Saitama

ZIP/Postal Code

343-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

State/Province

Shibuya Ku

ZIP/Postal Code

150 0013

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

Chuou-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

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

Setagaya-Ku

State/Province

Tokyo

ZIP/Postal Code

157-0072

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-0053

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima ku

State/Province

Tokyo

ZIP/Postal Code

170 0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Novartis Investigative Site

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-do

ZIP/Postal Code

26427

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

Country

Korea, Republic of

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

Seoul

State/Province

Korea

ZIP/Postal Code

03312

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

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

Riga

State/Province

ZIP/Postal Code

1011

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

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT-48259

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-49449

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Siauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Utena

ZIP/Postal Code

LT-28151

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-09108

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

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

Mexico

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Novartis Investigative Site

City

Lodz

State/Province

POL

ZIP/Postal Code

91-110

Country

Poland

Facility Name

Novartis Investigative Site

City

Wejherowo

State/Province

POL

ZIP/Postal Code

84-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Aleksandrow Odzki

ZIP/Postal Code

95-070

Country

Poland

Facility Name

Novartis Investigative Site

City

Biaystok

ZIP/Postal Code

15-430

Country

Poland

Facility Name

Novartis Investigative Site

City

Bielsko-Biala

ZIP/Postal Code

43-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Inowroclaw

ZIP/Postal Code

88-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40 085

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30033

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Novartis Investigative Site

City

Warsaw

ZIP/Postal Code

01518

Country

Poland

Facility Name

Novartis Investigative Site

City

Zawadzkie

ZIP/Postal Code

47-120

Country

Poland

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud Iasi

ZIP/Postal Code

700732

Country

Romania

Facility Name

Novartis Investigative Site

City

Constanta

State/Province

Jud. Constanta

ZIP/Postal Code

900002

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Jud.Dolj

ZIP/Postal Code

200341

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

ROM

ZIP/Postal Code

12071

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

ROM

ZIP/Postal Code

000000

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

ROM

ZIP/Postal Code

200712

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

State/Province

ROM

ZIP/Postal Code

330084

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

ROM

ZIP/Postal Code

300298

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

Bacau

ZIP/Postal Code

600114

Country

Romania

Facility Name

Novartis Investigative Site

City

Bragadiru

ZIP/Postal Code

077025

Country

Romania

Facility Name

Novartis Investigative Site

City

Braila

ZIP/Postal Code

810003

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500051

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

012363

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

050554

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400275

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Codlea

ZIP/Postal Code

505100

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

ZIP/Postal Code

200515

Country

Romania

Facility Name

Novartis Investigative Site

City

Ramnicu Valcea

ZIP/Postal Code

240564

Country

Romania

Facility Name

Novartis Investigative Site

City

Suceava

ZIP/Postal Code

720284

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

ZIP/Postal Code

540072

Country

Romania

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119192

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

N.Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440067

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Pyatigorsk

ZIP/Postal Code

357538

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

191123

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

192257

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214031

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190044

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

191180

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194291

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

193312

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.Petersburg

ZIP/Postal Code

196240

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

ZIP/Postal Code

400120

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Vologodonsk

ZIP/Postal Code

347382

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150023

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150040

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Beograd

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Sremska Kamenica

ZIP/Postal Code

21204

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

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

83103

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

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

State/Province

Slovak Republic

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Skalica

State/Province

Slovak Republic

ZIP/Postal Code

90901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

State/Province

Slovak Republic

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Stropkov

State/Province

Slovak Republic

ZIP/Postal Code

09101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Surany

State/Province

Slovak Republic

ZIP/Postal Code

942 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Velky Meder

State/Province

Slovak Republic

ZIP/Postal Code

94201

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Námestovo

State/Province

Slovensko

ZIP/Postal Code

02901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

State/Province

SVK

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bardejov

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cadca

ZIP/Postal Code

022 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ilava

ZIP/Postal Code

1901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Komarno

ZIP/Postal Code

945 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kralovsky Chlmec

ZIP/Postal Code

077 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

034 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Mikulas

ZIP/Postal Code

031 23

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Prievidza

ZIP/Postal Code

97101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Topolcany

ZIP/Postal Code

95501

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

01001

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

Panorama

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Novartis Investigative Site

City

Belleville

ZIP/Postal Code

7530

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

7700

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Fowey

State/Province

Cornwall

ZIP/Postal Code

PL23 1DT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liskeard

State/Province

Cornwall

ZIP/Postal Code

PL14 3XA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Torpoint

State/Province

Cornwall

ZIP/Postal Code

PL11 2TB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Faringdon

State/Province

Oxfordshire

ZIP/Postal Code

SN7 7YU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

State/Province

South Gloucestershire

ZIP/Postal Code

BS37 4AX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

ZIP/Postal Code

FY5 3LF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Denbighshire

ZIP/Postal Code

LL181DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC14 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 8AD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Rotherham

ZIP/Postal Code

S65 1DA

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

34452934

Citation

Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.

Results Reference

derived

PubMed Identifier

32653075

Citation

van Zyl-Smit RN, Krull M, Gessner C, Gon Y, Noga O, Richard A, de Los Reyes A, Shu X, Pethe A, Tanase AM, D'Andrea P; PALLADIUM trial investigators. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):987-999. doi: 10.1016/S2213-2600(20)30178-8. Epub 2020 Jul 9.

Results Reference

derived

Learn more about this trial

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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