| Primary | Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment. | Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period. | Posted | | Mean | Standard Error | Litres | | 1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.057± 0.013
- OG0010.055± 0.013
|
|
| | 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 |
|---|
| Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | ANCOVA | | 0.8937 | | Mean Difference (Final Values) | -0.002 | Standard Error of the Mean | 0.017 | 2-Sided | 95 | -0.035 | 0.031 | | | Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg | No | Superiority or Other | | |
|
| Secondary | Trough FEV1 Response [L] After 2 Weeks of Treatment | Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Individual FEV1 Measurements | Individual FEV1 measurements [L] at each time point on Day 29. The presented means are adjusted. | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FEV1 AUC 0-3h, Response | FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FEV1 Peak 0-3h Response | FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FEV1, AUC (0-6h) Response | FEV1, AUC (0-6h) response [L] on day 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FEV1 (Unsupervised) AUC (6-12h) Response | FEV1 (unsupervised) AUC (6-12h) response [L] on day 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 6 hours (h), 9h and 12h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Trough FVC Response | Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Individual FVC Measurements | Individual FVC measurements [L] at each time point The categories correspond to the planned times for FVC measurements on Day 29. The presented means are adjusted. | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FVC AUC (0-3h) Response | FVC AUC (0-3h) response [L] on days 1, 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FVC AUC (0-6h) Response | FVC AUC (0-6h) response [L] on day 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | FVC Peak 0-3h Response | FVC peak 0-3h response [L] on day 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | PEFR AUC (0-3h) Response | Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres / minute | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | PEFR Peak 0-3h Response | PEFR peak 0-3h response [L/min] on days 1, 15 and 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres / minute | | 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | PEFR AUC (6-12h) Response | PEFR AUC (6-12h) response [L] on day 29. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed). | | Posted | | Mean | Standard Error | Litres / minute | | 1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Weekly Mean Morning PEFR | Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4. The presented means are adjusted. | | Posted | | Mean | Standard Error | Litres / minute | | Weeks 1,2,3 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Weekly Mean Evening PEFR | Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4. The presented means are adjusted. | | Posted | | Mean | Standard Error | Litres / minute | | Weeks 1,2,3 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol]) | Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4. The means presented are the adjusted mean of weekly mean. | | Posted | | Mean | Standard Error | number of occasions / day | | Weeks 1,2,3 and 4 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | Patient Global Rating | Patient global rating scores treatment comparison after 4 weeks The score was evaluated on a 7-point scale :
- 1 : very much better
- 2 : much better
- 3 : a little better
- 4 : no change
- 5 : a little worse
- 6 : much worse
- 7 : very much worse
The presented means are adjusted. | | Posted | | Mean | Standard Error | units on a scale | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | Physician's Global Evaluation | Physician's global evaluation score on days 15 and 29 The score was evaluated on a 8-points scale :
- Poor : 1,2
- Fair : 3,4
- Good : 5,6
- Excellent : 7,8
The presented means are adjusted | | Posted | | Mean | Standard Error | units on a scale | | Days 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination | Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination | Treated Set (TS) including all randomized patients who received at least one dose of study medication. | Posted | | Number | | participants | | 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | Overall Marked Changes From Baseline in Vital Signs | Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate. | | Posted | | Number | | participants | | Baseline to week 14 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | 12-lead ECG Heart Rate | 12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM) Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | BPM | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | 12-lead ECG PR Intervals | 12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds. Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | mS | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| |
| Secondary | 12-lead ECG QRS Intervals | 12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | mS | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
|---|
| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | 12-lead ECG QTcF Intervals | 12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds. Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | mS | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
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| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | 12-lead ECG QTcB Intervals | 12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds. Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | mS | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
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| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | 12-lead ECG QT Intervals | 12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds. Statistics for each planned time from baseline to day 29. | | Posted | | Mean | Standard Deviation | mS | | Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29 | | | | ID | Title | Description |
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| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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| Secondary | AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised) |
- AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.
- FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.
- Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report.
| No patients analyzed in the study report. | Posted | | | | | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Olo 2 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | | OG001 | Olo 5 µg + Tio 5 µg | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
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