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NCT Number: NCT01294787

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

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).

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Frankfurt, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

indacaterol and glycopyrronium bromide (QVA149)

Drug

Placebo

Drug

Tiotropium

Drug

Primary outcomes

  1. Exercise Tolerance Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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 outcomes

  1. Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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.

  2. Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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.

  3. Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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.

  4. Pulmonary Function Test Comparison Between QVA149 and Placebo Groups

    Time frame: day 1 and day 21

    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.

  5. Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups

    Time frame: day 1 and day 21

    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.

  6. Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups

    Time frame: day 1 and day 21

    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.

  7. Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups

    Time frame: day 1 and day 21

    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.

  8. Spirometry After Three Weeks of Treatment on Patients Not Exercising

    Time frame: 3 weeks

    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.

  9. Exertional Dyspnea Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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.

  10. Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups

    Time frame: 3 weeks

    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.

  11. Exercise Endurance Comparison Between QVA149 and Tiotropium Groups

    Time frame: 3 weeks

    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.

  12. Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo

    Time frame: Day 1

    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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: BRIGHT

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2011
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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