| Primary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Seconds | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000507.8± 19.30
- OG001448.3± 19.49
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler. |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | day 1 and day 21 | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | day 1 and day 21 | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Kilo Pascal per second | | day 1 and day 21 | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | day 1 and day 21 | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Liters | | 3 weeks | | | | ID | Title | Description |
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| OG000 | Indacaterol and Glycopyrronium Bromide (QVA149) | QVA149 delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler. |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler. |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 3 weeks | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler. |
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| Secondary | 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. | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Seconds | | 3 weeks | | | | ID | Title | Description |
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| OG000 | Indacaterol and Glycopyrronium Bromide (QVA149) | QVA149 delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. |
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| Secondary | 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). | Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | | Least Squares Mean | Standard Error | Seconds | | Day 1 | | | | ID | Title | Description |
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| OG000 | QVA149 | Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler. | | OG001 | Tiotropium | Tiotropium delivered once daily via HandiHaler® device. | | OG002 | Placebo | Placebo, delivered once daily via single-dose dry powder inhaler |
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