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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Großhansdorf, Germany
Novartis Investigative Site
Hamburg, Germany
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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.
Time frame: day 1 and day 21
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Novartis Investigative Site
Lübeck, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Rüdersdorf, Germany
Novartis Investigative Site
Wiesbaden, Germany
Novartis Investigative Site
Alicante, Spain
Novartis Investigative Site
Badalona, Spain
Novartis Investigative Site
Barakaldo, Spain
...and 3 more locations
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.
Time frame: day 1 and day 21
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.
Time frame: day 1 and day 21
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.
Time frame: day 1 and day 21
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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.
Time frame: 3 weeks
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).
Time frame: Day 1