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A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QVA149

QAB149

NVA237

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, QVA149

Eligibility Criteria

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

Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QVA149

QAB149

NVA237

Placebo

Arm Description

27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)

27.5 ug b.i.d.

12.5 ug b.i.d.

b.i.d

Outcomes

Primary Outcome Measures

Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))

Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.

Secondary Outcome Measures

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

Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement.

Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score

Change From Baseline in Trough FEV1

Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.

Change From Baseline in Pre-dose Trough FEV1

Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.

Change From Baseline in FEV1

Change From Baseline in FVC

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

Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)

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

Transitional Dyspnea Index (TDI) Focal Score

The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication

Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.

Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score

The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.

Full Information

NCT ID

NCT01727141

First Posted

November 12, 2012

Last Updated

March 2, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01727141

Brief Title

A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

Official Title

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

NOTE: Detailed Description: data not entered

6. Conditions and Keywords

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

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1042 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)

Arm Title

QAB149

Arm Type

Active Comparator

Arm Description

27.5 ug b.i.d.

Arm Title

NVA237

Arm Type

Active Comparator

Arm Description

12.5 ug b.i.d.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

b.i.d

Intervention Type

Drug

Intervention Name(s)

QVA149

Intervention Description

QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

Intervention Type

Drug

Intervention Name(s)

QAB149

Intervention Description

QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Intervention Type

Drug

Intervention Name(s)

NVA237

Intervention Description

NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Primary Outcome Measure Information:

Title

Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))

Description

Time Frame

baseline (BL), 12 Weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

BL, 12 Weeks

Title

Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score

Description

Time Frame

12 weeks

Title

Change From Baseline in Trough FEV1

Description

Time Frame

BL, day 2, day 86

Title

Change From Baseline in Pre-dose Trough FEV1

Description

Time Frame

BL, day 85

Title

Change From Baseline in FEV1

Description

Time Frame

BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min

Title

Change From Baseline in FVC

Description

Time Frame

BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min

Title

Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)

Description

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

Time Frame

BL, day 1, week 12

Title

Transitional Dyspnea Index (TDI) Focal Score

Description

Time Frame

BL, 12 weeks

Title

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication

Description

Time Frame

BL, 12 Weeks

Title

Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score

Description

Time Frame

BL, 12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients that have signed informed consent and are >/= 40 years of age. Patients with stable COPD according to GOLD 2011. Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70. Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with an mMRC grade 2 or greater. Exclusion Criteria: Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.) Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.) Patients with a history of malignancy of any organ system, treated or untreated, within the last five years. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention. Patients who had a COPD exacerbation within 6 weeks prior to screening. Patients who have a respiratory tract infection within 4 weeks prior to screening. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day. Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in. Patients with concomitant pulmonary disease. Patients with a diagnosis of alpha-1 anti-trypsin deficiency. Patients with active pulmonary tuberculosis. Patients in the active phase of a pulmonary rehabilitation programme. 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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Novartis Investigative Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36109

Country

United States

Facility Name

Novartis Investigative Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85205

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Novartis Investigative Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Novartis Investigative Site

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Novartis Investigative Site

City

Orangevale

State/Province

California

ZIP/Postal Code

95662

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

Paramount

State/Province

California

ZIP/Postal Code

90723

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

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95823

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92117-4946

Country

United States

Facility Name

Novartis Investigative Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Novartis Investigative Site

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Novartis Investigative Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Novartis Investigative Site

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Novartis Investigative Site

City

Lynn Haven

State/Province

Florida

ZIP/Postal Code

32444

Country

United States

Facility Name

Novartis Investigative Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Novartis Investigative Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Novartis Investigative Site

City

O'Fallon

State/Province

Illinois

ZIP/Postal Code

62269

Country

United States

Facility Name

Novartis Investigative Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Novartis Investigative Site

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02154

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106-0525

Country

United States

Facility Name

Novartis Investigative Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Novartis Investigative Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55901

Country

United States

Facility Name

Novartis Investigative Site

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Novartis Investigative Site

City

St. Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Novartis Investigative Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Novartis Investigative Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11234

Country

United States

Facility Name

Novartis Investigative Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Novartis Investigative Site

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28739

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Novartis Investigative Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Novartis Investigative Site

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504-8741

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15221

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Novartis Investigative Site

City

Tipton

State/Province

Pennsylvania

ZIP/Postal Code

16684

Country

United States

Facility Name

Novartis Investigative Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Novartis Investigative Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Novartis Investigative Site

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Facility Name

Novartis Investigative Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

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

Dallas

State/Province

Texas

ZIP/Postal Code

75231-4307

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Novartis Investigative Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Novartis Investigative Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 3J5

Country

Canada

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Novartis Investigative Site

City

Courtice

State/Province

Ontario

ZIP/Postal Code

L1E 3C3

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1N8

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M2

Country

Canada

Facility Name

Novartis Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 3j1

Country

Canada

Facility Name

Novartis Investigative Site

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1J 2G2

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Charles-Borromée

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Romuald

State/Province

Quebec

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Victoriaville

State/Province

Quebec

ZIP/Postal Code

G6P 6P6

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

GIV 4M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Novartis Investigative Site

City

San Pablo City, Laguna

ZIP/Postal Code

4000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

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

51-162

Country

Poland

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

10457

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

11475

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030303

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200515

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310013

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330162

Country

Romania

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Gijon

State/Province

Asturias

ZIP/Postal Code

33290

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

State/Province

Castilla y Leon

ZIP/Postal Code

24400

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla y Leon

ZIP/Postal Code

47011

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Salt

State/Province

Cataluña

ZIP/Postal Code

17190

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Boi de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08830

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Mérida

State/Province

Extremadura

ZIP/Postal Code

06800

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

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Donetsk

ZIP/Postal Code

83099

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61172

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kiev

ZIP/Postal Code

02232

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kiev

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Luhansk

ZIP/Postal Code

91055

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Lviv

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Poltava

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Zaporizhzhya

ZIP/Postal Code

69104

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Hanoi

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh City

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

31539467

Citation

Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.

Results Reference

derived

PubMed Identifier

26177074

Citation

Mahler DA, Kerwin E, Ayers T, FowlerTaylor A, Maitra S, Thach C, Lloyd M, Patalano F, Banerji D. FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1068-79. doi: 10.1164/rccm.201505-1048OC.

Results Reference

derived

Learn more about this trial

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A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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