Trial record 1 of 1 for:    NCT01294787.
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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BRIGHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01294787
First received: February 10, 2011
Last updated: March 19, 2013
Last verified: March 2013

February 10, 2011
March 19, 2013
February 2011
November 2011   (final data collection date for primary outcome measure)
Exercise Tolerance Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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.
The effect of QVA149 compared with placebo on exercise tolerance [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Exercise duration time (measured via constant load cycle ergometry)
Complete list of historical versions of study NCT01294787 on ClinicalTrials.gov Archive Site
  • Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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).
  • The effect of QVA149 compared with placebo on inspiratory capacity (IC) during exercise [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of QVA149 compared with placebo on exertional dyspnea and leg discomfort during exercise [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Measured by the Borg CR10 Scale® (dyspnea, leg discomfort)
Not Provided
Not Provided
 
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • Drug: indacaterol and glycopyrronium bromide (QVA149)
  • Drug: placebo
  • Drug: tiotropium
  • Experimental: indacaterol and glycopyrronium bromide (QVA149)
    QVA149 delivered once daily via single-dose dry powder inhaler.
    Intervention: Drug: indacaterol and glycopyrronium bromide (QVA149)
  • Placebo Comparator: placebo
    Placebo, delivered once daily via single-dose dry powder inhaler.
    Intervention: Drug: placebo
  • Active Comparator: tiotropium
    Tiotropium delivered once daily via HandiHaler® device.
    Intervention: Drug: tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
November 2011
November 2011   (final data collection date for primary outcome measure)

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

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain
 
NCT01294787
CQVA149A2305, 2010-022721-14
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP