| Primary | FEV1 peak0-3 Change From Baseline | Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24. Note, the measured values presented are actually adjusted means. | Full analysis set (FAS) was the same as the treated set which included all randomised patients who were dispensed trial medication and received at least one documents dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.373± 0.037
- OG0010.507± 0.040
- OG0020.547± 0.038
|
|
| | 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 | | 0.0085 | | Mean Difference (Final Values) | 0.134 | Standard Error of the Mean | 0.051 | 2-Sided | 95 | 0.034 | 0.234 | | | Difference calculated as Tio R2.5 minus placebo | No | Superiority or Other | | | | | Mixed Models Analysis |
|
| Secondary | Trough FEV1 Change From Baseline | Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24. The measured values presented are actually adjusted means. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | FVC peak0-3 Change From Baseline | Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0-3h) after 24 weeks of treatment. The measured values presented are actually adjusted means. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Trough FVC Change From Baseline | Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment. The measured values presented are actually adjusted means.. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | FEV1 AUC (0-3h) Change From Baseline | Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h). The measured values presented are actually adjusted means. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | FVC AUC (0-3h) Change From Baseline | Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h). The measured values presented are actually adjusted means. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres | | Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | FEF25-75 Change From Baseline | Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment. The measured values presented are actually adjusted means. | Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model. | Posted | | Mean | Standard Error | Litres per second | | Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Use of PRN Rescue Medication During the Daytime | Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24. The measured values presented are actually adjusted means. | | Posted | | Mean | Standard Error | Number of puffs of rescue medication | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Use of PRN Rescue Medication During the Night-time | Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24. The measured values presented are actually adjusted means. | | Posted | | Mean | Standard Error | Number of puffs of rescue medication | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Use of PRN Rescue Medication During the Day | Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24. The measured values presented are actually adjusted means. | | Posted | | Mean | Standard Error | Number of puffs of rescue medication | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Control of Asthma as Assessed by ACQ Total Score | Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions. The measured values presented are actually adjusted means. | | Posted | | Mean | Standard Error | Units on a scale | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | ACQ Total Score Responders | Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 \ | | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Control of Asthma as Assessed by ACQ6 | Change from baseline in AQC6 score at week 24. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. The measured values presented are actually adjusted means. | | Posted | | Mean | Standard Error | units on a scale | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | ACQ6 Responders | Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 \ | | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period | The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days. | | Posted | | Number | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |
| Secondary | Time to First Asthma Exacerbation During the 48 Week Treatment Period | The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values. | | Posted | | Number | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Respimat | Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG001 | Tio R2.5 | Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler | | OG002 | Tio R5 | Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler |
| |