| Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | After 14 days | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 | Salmeterol 50 μg | Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.46± 0.027
- OG0011.26± 0.027
- OG0021.37± 0.027
|
|
| |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 5 minutes post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 15 minutes post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 30 minutes post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 1 hour post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 2 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 3 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 4 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 5 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 6 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 8 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 10 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 11 hours 10 minutes post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 11 hours 45 minutes post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 14 hours post-dose at the end of each treatment period (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 20 hours 10 minutes post-dose at the end of each treatment period (Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 20 hours 45 minutes post-dose at the end of each treatment period (Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 22 hours post-dose at the end of each treatment period (Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 23 hours 10 minutes post-dose at the end of each treatment period (Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | Liters | | 23 hours 45 minutes post-dose at the end of each treatment period (Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Indacaterol 300 μg | Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG001 | Placebo to Indacaterol | Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | | OG002 |
|