| Primary | Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose | At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.875± 0.019
- OG0011.990± 0.019
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect. | <0.001 | | Mean Difference (Final Values) | 0.115 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | 0.077 | 0.153 | | | Adjusted mean of differences between treatments and standard error | | Superiority | | Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values. |
|
| Secondary | 6-minute Walk Distance [Meter] | 6-minute walk distance [Meter] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Meter (m) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | Average Number of Step Per Day (Step/Day) | At day 43 adjusted mean (SE) of average number of step per day [step/day] treatment comparisons in measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | step/day | | 2 weeks prior to Week 6 per treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs) | At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 4 METs treatment comparisons measured by the activity monitor in the 2 weeks prior to week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | minute | | 2 weeks prior to Week 6 per treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs) | At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | minute | | 2 weeks prior to Week 6 per treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs) | At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 2 METs treatment comparison measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | minute | | 2 weeks prior to Week 6 per treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs | At day 43 adjusted mean (SE) of average daily active strength [METs x minute] of >=3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Metabolic equivalents * minutes | | 2 weeks prior to Week 6 per treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | 60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre) | At day 43 adjusted mean (SE) of 60 minute post-dose slow vital capacity [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | 30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre) | At day 43 adjusted mean (SE) of 30 minute post-dose forced expiratory volume in one second (FEV1) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 30 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Secondary | 30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre) | At day 43 adjusted mean (SE) of 30 minute post-dose forced vital capacity (FVC) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 30 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Treatment Period | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Baseline Period | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Test Comparisons of 6-Minute Walk Treatment (6MWT) in-Completer at Treatment Period | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT in-completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) in-Completer at Baseline Period | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each test for 6MWT in-completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage I/II | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage I/II. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |
| Post-Hoc | Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III/IV | At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage III/IV. Adjusted mean was entered instead of mean in statistical analysis. | Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses. | Posted | | Mean | Standard Error | Litre (L) | | Day 43, 60 minutes post-dose after 6 weeks of each treatment | | | | ID | Title | Description |
|---|
| OG000 | Tiotropium 5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. | | OG001 | Tiotropium + Olodaterol 5/5 μg | Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks. |
| |