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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BRIGHT)

Primary Purpose

COPD

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
indacaterol and glycopyrronium bromide (QVA149)
placebo
tiotropium
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, QVA149, tiotropium, exercise, exercise tolerance, combination bronchodilator, moderate to severe COPD

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
  • Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
  • Smoking history ≥ 10 pack years

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
  • Cardiac abnormality
  • History of asthma
  • Contraindications to cardiopulmonary exercise testing
  • Participation in active phase of pulmonary rehabilitation program
  • History of cancer within the past 5 years

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

indacaterol and glycopyrronium bromide (QVA149)

placebo

tiotropium

Arm Description

QVA149 delivered once daily via single-dose dry powder inhaler.

Placebo, delivered once daily via single-dose dry powder inhaler.

Tiotropium delivered once daily via HandiHaler® device.

Outcomes

Primary Outcome Measures

Exercise Tolerance Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.

Secondary Outcome Measures

Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.
Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.
Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.
Pulmonary Function Test Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Spirometry After Three Weeks of Treatment on Patients Not Exercising
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.
Exertional Dyspnea Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness). A reduction in this score indicates an improvement.
Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.
Exercise Endurance Comparison Between QVA149 and Tiotropium Groups
Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.
Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo
The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).

Full Information

First Posted
February 10, 2011
Last Updated
March 19, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01294787
Brief Title
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
BRIGHT
Official Title
A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, QVA149, tiotropium, exercise, exercise tolerance, combination bronchodilator, moderate to severe COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
indacaterol and glycopyrronium bromide (QVA149)
Arm Type
Experimental
Arm Description
QVA149 delivered once daily via single-dose dry powder inhaler.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, delivered once daily via single-dose dry powder inhaler.
Arm Title
tiotropium
Arm Type
Active Comparator
Arm Description
Tiotropium delivered once daily via HandiHaler® device.
Intervention Type
Drug
Intervention Name(s)
indacaterol and glycopyrronium bromide (QVA149)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
tiotropium
Primary Outcome Measure Information:
Title
Exercise Tolerance Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.
Time Frame
3 weeks
Title
Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.
Time Frame
3 weeks
Title
Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.
Time Frame
3 weeks
Title
Pulmonary Function Test Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Time Frame
day 1 and day 21
Title
Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Time Frame
day 1 and day 21
Title
Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Time Frame
day 1 and day 21
Title
Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.
Time Frame
day 1 and day 21
Title
Spirometry After Three Weeks of Treatment on Patients Not Exercising
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.
Time Frame
3 weeks
Title
Exertional Dyspnea Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness). A reduction in this score indicates an improvement.
Time Frame
3 weeks
Title
Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups
Description
The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.
Time Frame
3 weeks
Title
Exercise Endurance Comparison Between QVA149 and Tiotropium Groups
Description
Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.
Time Frame
3 weeks
Title
Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo
Description
The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009) Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity) Smoking history ≥ 10 pack years Exclusion Criteria: Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception Cardiac abnormality History of asthma Contraindications to cardiopulmonary exercise testing Participation in active phase of pulmonary rehabilitation program History of cancer within the past 5 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
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Grosshansdorf
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Rudersdorf
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
Country
Germany
Facility Name
Novartis Investigative Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
Country
Spain
Facility Name
Novartis Investigative Site
City
Barakaldo
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24534204
Citation
Beeh KM, Korn S, Beier J, Jadayel D, Henley M, D'Andrea P, Banerji D. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014 Apr;108(4):584-92. doi: 10.1016/j.rmed.2014.01.006. Epub 2014 Jan 21.
Results Reference
derived

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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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