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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.) 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

Primary: 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.

Secondary: 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.

Secondary: 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.

Secondary: 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

NCT01712516

First Posted

October 19, 2012

Last Updated

July 13, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01712516

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

December 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 indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

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

1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

27.5/12.5 ug twice daily (b.i.d.) 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

Primary: 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, 11h; day 86: 23h15min; 23h45min

Title

Change From Baseline in FVC

Description

Time Frame

Title

Secondary: 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, 12 weeks

Title

Transitional Dyspnea Index (TDI) Focal Score

Description

Time Frame

BL, 12 weeks

Title

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

Description

Time Frame

BL, 12 weeks

Title

Secondary: 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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Novartis Investigative Site

City

*See Various Dept.'s*

State/Province

Arizona

Country

United States

Facility Name

Novartis Investigative Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Facility Name

Novartis Investigative Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

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

Palmdale

State/Province

California

ZIP/Postal Code

93551

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

92120

Country

United States

Facility Name

Novartis Investigative Site

City

Sepulveda

State/Province

California

ZIP/Postal Code

91343

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

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

Deland

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Novartis Investigative Site

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33316-192

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Novartis Investigative Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Novartis Investigative Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

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

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Novartis Investigative Site

City

Opelousas

State/Province

Louisiana

ZIP/Postal Code

70570

Country

United States

Facility Name

Novartis Investigative Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Novartis Investigative Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89520

Country

United States

Facility Name

Novartis Investigative Site

City

Brandon

State/Province

New Jersey

ZIP/Postal Code

33511

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigative Site

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Novartis Investigative Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Novartis Investigative Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28152

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406-7108

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Novartis Investigative Site

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Novartis Investigative Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

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

Pelzer

State/Province

South Carolina

ZIP/Postal Code

29669

Country

United States

Facility Name

Novartis Investigative Site

City

Rock Hll

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Novartis Investigative Site

City

Seneca

State/Province

South Carolina

ZIP/Postal Code

29678

Country

United States

Facility Name

Novartis Investigative Site

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

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

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Novartis Investigative Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Novartis Investigative Site

City

Ft. Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Novartis Investigative Site

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75708

Country

United States

Facility Name

Novartis Investigative Site

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Novartis Investigative Site

City

Armenia

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

Novartis Investigative Site

City

Beuvry

ZIP/Postal Code

62660

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

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

01015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mako

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szazhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Tatabanya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Panama City

State/Province

Panamá

Country

Panama

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

Humenne

State/Province

Slovak Republic

ZIP/Postal Code

066 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

State/Province

Slovak Republic

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

State/Province

Slovak Republic

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Vrable

State/Province

Slovak Republic

ZIP/Postal Code

952 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Galanta

ZIP/Postal Code

92422

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

Martin

ZIP/Postal Code

036 01

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

Spisská Nová Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Golnik

ZIP/Postal Code

4204

Country

Slovenia

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

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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

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