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Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QMF149

Salmeterol

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD

Eligibility Criteria

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

Inclusion Criteria:

Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.

Exclusion Criteria:

Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (Visit 1).
Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
Patients requiring long term oxygen therapy prescribed for >12 hours per day.
Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QMF149

Salmeterol xinafoate/fluticasone propionate

Arm Description

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device

Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®

Outcomes

Primary Outcome Measures

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85

Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

Secondary Outcome Measures

Trough FEV1 After First Dose and After 4 Weeks of Treatment

Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint

Forced Vital Capacity (FVC) at Each Timepoint

Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.

FEV1/FVC at Each Timepoint

Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.

FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)

Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment.

FEV1 AUC (5 Min-4 h),

Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)

The Usage of Rescue Medication (Short Acting β2-agonist)

Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.

The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .

This value represents the percent of days in the study where no rescue medication was needed.

Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)

A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.

Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit

A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit

Patient Reported Outcome Measures: COPD Assessment Test

It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.

Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale

Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score. • Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15.

Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale

The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.

Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)

The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.

Time to First COPD Exacerbation

Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.

Annual Rate of COPD Exacerbations

Duration (in Days) of COPD Exacerbations

Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.

Percentage of Patients With at Least One Exacerbation up to Week 12

Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation

The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation

Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period

Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.

Plasma Cortisol Concentrations at Each Timepoint

Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.

Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint

Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.

Pharmacokinetic Parameter: Cmax

Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.

Pharmacokinetic Parameter--Tmax

Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.

Pharmacokinetic Parameter--AUC0-t

Area under the plasma concentration time curve from time zero to time "t" post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.

Full Information

NCT ID

NCT01636076

First Posted

July 5, 2012

Last Updated

November 13, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01636076

Brief Title

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Official Title

A Randomized, Double-blind, 12-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of QMF149 (150 µg/160 µg o.d.) Compared With Salmeterol Xinafoate/Fluticasone Propionate (50 µg/500 µg b.i.d.) in Patients With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

6. Conditions and Keywords

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

COPD

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

629 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QMF149

Arm Type

Experimental

Arm Description

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device

Arm Title

Salmeterol xinafoate/fluticasone propionate

Arm Type

Active Comparator

Arm Description

Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®

Intervention Type

Drug

Intervention Name(s)

QMF149

Intervention Description

delivered via Concept1 device

Intervention Type

Drug

Intervention Name(s)

Salmeterol

Intervention Description

delivered via Accuhaler®

Primary Outcome Measure Information:

Title

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85

Description

Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Trough FEV1 After First Dose and After 4 Weeks of Treatment

Description

Time Frame

Day 1 and Day 85

Title

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint

Time Frame

Day 1 through day 85

Title

Forced Vital Capacity (FVC) at Each Timepoint

Description

Time Frame

Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85

Title

FEV1/FVC at Each Timepoint

Description

Time Frame

Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85

Title

FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)

Description

Time Frame

Day 1

Title

FEV1 AUC (5 Min-4 h),

Description

Time Frame

Day 1(Baseline), Day 28, Day 84

Title

Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)

Description

Time Frame

Day 28, Day 84

Title

The Usage of Rescue Medication (Short Acting β2-agonist)

Description

Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.

Time Frame

12 weeks

Title

The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .

Description

This value represents the percent of days in the study where no rescue medication was needed.

Time Frame

Baseline to 12 weeks

Title

Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)

Description

Time Frame

4 and 12 weeks

Title

Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit

Description

Time Frame

4 and 12 weeks

Title

Patient Reported Outcome Measures: COPD Assessment Test

Description

Time Frame

Baseline, 4 and 12 weeks

Title

Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale

Description

Time Frame

Baseline, 4 and 12 weeks

Title

Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale

Description

The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.

Time Frame

Baseline, 4 and 12 weeks

Title

Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)

Description

The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.

Time Frame

12 weeks

Title

Time to First COPD Exacerbation

Description

Time Frame

12 weeks

Title

Annual Rate of COPD Exacerbations

Description

Time Frame

12 weeks

Title

Duration (in Days) of COPD Exacerbations

Description

Time Frame

12 weeks

Title

Percentage of Patients With at Least One Exacerbation up to Week 12

Description

Time Frame

12 weeks

Title

Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation

Description

Time Frame

12 weeks

Title

The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation

Description

Time Frame

12 weeks

Title

Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period

Description

Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.

Time Frame

12 weeks

Title

Plasma Cortisol Concentrations at Each Timepoint

Description

Time Frame

Day 1, Day 28, Day 84

Title

Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint

Description

Time Frame

Day 1, 29, 84

Title

Pharmacokinetic Parameter: Cmax

Description

Time Frame

Day 28, 84

Title

Pharmacokinetic Parameter--Tmax

Description

Time Frame

Day 28, 84

Title

Pharmacokinetic Parameter--AUC0-t

Description

Time Frame

Day 28, 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101). Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening. Exclusion Criteria: Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (Visit 1). Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1. Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection. Patients requiring long term oxygen therapy prescribed for >12 hours per day. Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years. Other protocol-defined inclusion/exclusion criteria may apply.

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

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

New Lambton Heights

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Novartis Investigative Site

City

Redcliffe

State/Province

Queensland

ZIP/Postal Code

4020

Country

Australia

Facility Name

Novartis Investigative Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Novartis Investigative Site

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

Novartis Investigative Site

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Novartis Investigative Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novartis Investigative Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Novartis Investigative Site

City

Franston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Halen

ZIP/Postal Code

3545

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Russe

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1234

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

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

Odense C

ZIP/Postal Code

DK-5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Pori

ZIP/Postal Code

FIN-28500

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

FIN-33521

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20100

Country

Finland

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Donaustauf

ZIP/Postal Code

93093

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Großhansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65187

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Heraklion Crete

State/Province

Crete

ZIP/Postal Code

GR-71110

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens - GR

ZIP/Postal Code

10676

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 115 27

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

GR 41110

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 56403

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Balasagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Novartis Investigative Site

City

Farkasgyepu

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kapuvár

ZIP/Postal Code

9330

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pécs

ZIP/Postal Code

7633

Country

Hungary

Facility Name

Novartis Investigative Site

City

Siofok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Sopron

ZIP/Postal Code

H-9401

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

34362

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

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

Batu Caves

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Taiping

ZIP/Postal Code

34000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-270

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-461

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-211

Country

Poland

Facility Name

Novartis Investigative Site

City

Ilawa

ZIP/Postal Code

14-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Pila

ZIP/Postal Code

64-920

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Novartis Investigative Site

City

Szczecin

ZIP/Postal Code

71-124

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-434

Country

Poland

Facility Name

Novartis Investigative Site

City

Constanta

State/Province

Jud. Constanta

ZIP/Postal Code

900002

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

50159

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400162

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu-Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2057

Country

South Africa

Facility Name

Novartis Investigative Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7531

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Umkomaas

ZIP/Postal Code

4170

Country

South Africa

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46015

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

405 30

Country

Sweden

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

412 63

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Malmö

ZIP/Postal Code

21152

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vällingby

ZIP/Postal Code

162 68

Country

Sweden

Facility Name

Novartis Investigative Site

City

Taladkwan

State/Province

Nonthaburi

ZIP/Postal Code

11000

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Muang

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Nakhon Naiyok

ZIP/Postal Code

26120

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial