Trial Outcomes & Findings for Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01040403)
NCT ID: NCT01040403
Last Updated: 2015-07-15
Results Overview
Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
Results posted on
2015-07-15
Participant Flow
This was a randomised, 4-period incomplete cross-over trial. 233 patients were randomized to one of 14 treatment sequences and 232 of them were treated. It was a double-blind trial in which each treatment period lasted 4 weeks with a washout period of 21 days between each.
Participant milestones
| Measure |
Overall Study
A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
* Olodaterol 5 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution
* Olodaterol 10 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution
|
|---|---|
|
Overall Study
STARTED
|
233
|
|
Overall Study
Completed Olo 5
|
106
|
|
Overall Study
Completed T+O 1.25/5
|
105
|
|
Overall Study
Completed T+O 2.5/5
|
111
|
|
Overall Study
Completed T+O 5/5
|
106
|
|
Overall Study
Completed Olo 10
|
109
|
|
Overall Study
Completed T+O 1.25/10
|
106
|
|
Overall Study
Completed T+O 2.5/10
|
110
|
|
Overall Study
Completed T+O 5/10
|
107
|
|
Overall Study
COMPLETED
|
213
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Overall Study
A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
* Olodaterol 5 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution
* Olodaterol 10 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Not treated
|
1
|
|
Overall Study
Other reason not defined above
|
6
|
Baseline Characteristics
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Overall Study
n=232 Participants
A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
* Olodaterol 5 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution
* Olodaterol 10 µg and placebo
* Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution
* Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution
|
|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29Population: Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.
Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 Response
|
0.071 Litres
Standard Deviation 0.018
|
0.125 Litres
Standard Deviation 0.018
|
0.136 Litres
Standard Deviation 0.018
|
0.155 Litres
Standard Deviation 0.018
|
0.083 Litres
Standard Deviation 0.018
|
0.134 Litres
Standard Deviation 0.018
|
0.166 Litres
Standard Deviation 0.018
|
0.163 Litres
Standard Deviation 0.018
|
SECONDARY outcome
Timeframe: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29Population: FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.
Adjusted means of trough FVC (forced vital capacity) response \[L\] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Trough Forced Vital Capacity (FVC) Response
|
0.114 Litres
Standard Error 0.029
|
0.214 Litres
Standard Error 0.029
|
0.234 Litres
Standard Error 0.029
|
0.215 Litres
Standard Error 0.029
|
0.122 Litres
Standard Error 0.029
|
0.253 Litres
Standard Error 0.029
|
0.253 Litres
Standard Error 0.029
|
0.249 Litres
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29Population: FAS
Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses \[L\] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 AUC 0-3h and FEV1 AUC 0-6h Response
AUC 0-3h
|
0.183 Litres
Standard Deviation 0.020
|
0.258 Litres
Standard Deviation 0.020
|
0.280 Litres
Standard Deviation 0.020
|
0.302 Litres
Standard Deviation 0.020
|
0.191 Litres
Standard Deviation 0.020
|
0.288 Litres
Standard Deviation 0.020
|
0.319 Litres
Standard Deviation 0.020
|
0.334 Litres
Standard Deviation 0.020
|
|
FEV1 AUC 0-3h and FEV1 AUC 0-6h Response
AUC 0-6h
|
0.188 Litres
Standard Deviation 0.020
|
0.267 Litres
Standard Deviation 0.020
|
0.287 Litres
Standard Deviation 0.020
|
0.307 Litres
Standard Deviation 0.020
|
0.198 Litres
Standard Deviation 0.020
|
0.296 Litres
Standard Deviation 0.020
|
0.320 Litres
Standard Deviation 0.020
|
0.342 Litres
Standard Deviation 0.020
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1Population: FAS
Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response \[L\] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 AUC 0-3h Response After the First Dose
|
0.204 Litres
Standard Deviation 0.017
|
0.181 Litres
Standard Deviation 0.017
|
0.209 Litres
Standard Deviation 0.017
|
0.205 Litres
Standard Deviation 0.017
|
0.188 Litres
Standard Deviation 0.017
|
0.227 Litres
Standard Deviation 0.017
|
0.219 Litres
Standard Deviation 0.017
|
0.230 Litres
Standard Deviation 0.017
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29Population: FAS
Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response \[L\] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 Peak 0-3h Response
|
0.264 Litres
Standard Error 0.023
|
0.353 Litres
Standard Error 0.023
|
0.355 Litres
Standard Error 0.023
|
0.379 Litres
Standard Error 0.023
|
0.267 Litres
Standard Error 0.023
|
0.374 Litres
Standard Error 0.023
|
0.399 Litres
Standard Error 0.023
|
0.412 Litres
Standard Error 0.023
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1Population: FAS
Adjusted means of the FEV1 peak 0-3h response \[L\] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 Peak 0-3h Response After the First Dose
|
0.287 Litres
Standard Error 0.019
|
0.267 Litres
Standard Error 0.019
|
0.300 Litres
Standard Error 0.019
|
0.298 Litres
Standard Error 0.019
|
0.270 Litres
Standard Error 0.019
|
0.324 Litres
Standard Error 0.019
|
0.315 Litres
Standard Error 0.019
|
0.317 Litres
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29Population: FAS
Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses \[L\] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FVC AUC 0-3h and FEV1 AUC 0-6h Responses
AUC 0-3h
|
0.278 Litres
Standard Error 0.032
|
0.422 Litres
Standard Error 0.032
|
0.429 Litres
Standard Error 0.032
|
0.410 Litres
Standard Error 0.032
|
0.279 Litres
Standard Error 0.032
|
0.455 Litres
Standard Error 0.032
|
0.454 Litres
Standard Error 0.032
|
0.479 Litres
Standard Error 0.032
|
|
FVC AUC 0-3h and FEV1 AUC 0-6h Responses
AUC 0-6h
|
0.282 Litres
Standard Error 0.032
|
0.421 Litres
Standard Error 0.032
|
0.432 Litres
Standard Error 0.032
|
0.414 Litres
Standard Error 0.032
|
0.277 Litres
Standard Error 0.032
|
0.466 Litres
Standard Error 0.032
|
0.456 Litres
Standard Error 0.032
|
0.490 Litres
Standard Error 0.032
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1Population: FAS
Adjusted means of the FVC AUC 0-3h response \[L\] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FVC AUC 0-3h Response After First Dose
|
0.333 Litres
Standard Error 0.029
|
0.285 Litres
Standard Error 0.029
|
0.326 Litres
Standard Error 0.029
|
0.319 Litres
Standard Error 0.030
|
0.303 Litres
Standard Error 0.029
|
0.393 Litres
Standard Error 0.030
|
0.363 Litres
Standard Error 0.029
|
0.359 Litres
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29Population: FAS
Adjusted means of the FVC peak 0-3h response \[L\] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FVC Peak 0-3h Response
|
0.415 Litres
Standard Error 0.035
|
0.570 Litres
Standard Error 0.035
|
0.563 Litres
Standard Error 0.035
|
0.542 Litres
Standard Error 0.035
|
0.411 Litres
Standard Error 0.035
|
0.585 Litres
Standard Error 0.035
|
0.593 Litres
Standard Error 0.035
|
0.615 Litres
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1Population: FAS
Adjusted mean of the FVC peak 0-3h response \[L\] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
FVC Peak 0-3h Response After the First Dose
|
0.473 Litres
Standard Error 0.031
|
0.423 Litres
Standard Error 0.031
|
0.481 Litres
Standard Error 0.031
|
0.462 Litres
Standard Error 0.032
|
0.436 Litres
Standard Error 0.031
|
0.547 Litres
Standard Error 0.032
|
0.517 Litres
Standard Error 0.031
|
0.505 Litres
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29Population: FAS
Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
PEF AUC 0-3h and AUC 0-6h Responses
AUC 0-3h
|
25.542 L/min
Standard Error 4.190
|
44.301 L/min
Standard Error 4.202
|
50.698 L/min
Standard Error 4.167
|
55.346 L/min
Standard Error 4.234
|
29.713 L/min
Standard Error 4.183
|
48.032 L/min
Standard Error 4.218
|
53.224 L/min
Standard Error 4.192
|
52.531 L/min
Standard Error 4.205
|
|
PEF AUC 0-3h and AUC 0-6h Responses
AUC 0-6h
|
28.071 L/min
Standard Error 4.125
|
46.822 L/min
Standard Error 4.136
|
54.081 L/min
Standard Error 4.104
|
57.418 L/min
Standard Error 4.166
|
31.831 L/min
Standard Error 4.119
|
51.485 L/min
Standard Error 4.151
|
54.593 L/min
Standard Error 4.127
|
57.367 L/min
Standard Error 4.139
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1Population: FAS
Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
PEF AUC 0-3h Response After the First Dose
|
30.575 L/min
Standard Error 4.047
|
32.891 L/min
Standard Error 4.050
|
35.053 L/min
Standard Error 4.022
|
35.243 L/min
Standard Error 4.084
|
31.724 L/min
Standard Error 4.040
|
33.213 L/min
Standard Error 4.079
|
34.987 L/min
Standard Error 4.051
|
38.846 L/min
Standard Error 4.065
|
SECONDARY outcome
Timeframe: Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29Population: FAS
Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
PEF Peak 0-3h Response
|
46.010 L/min
Standard Error 4.566
|
64.693 L/min
Standard Error 4.581
|
69.610 L/min
Standard Error 4.538
|
76.108 L/min
Standard Error 4.620
|
49.025 L/min
Standard Error 4.557
|
66.767 L/min
Standard Error 4.600
|
73.140 L/min
Standard Error 4.569
|
74.120 L/min
Standard Error 4.584
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1Population: FAS
Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
PEF Peak 0-3h Response After the First Dose
|
52.129 L/min
Standard Error 4.363
|
53.298 L/min
Standard Error 4.366
|
56.565 L/min
Standard Error 4.335
|
57.318 L/min
Standard Error 4.406
|
51.980 L/min
Standard Error 4.355
|
54.966 L/min
Standard Error 4.400
|
56.896 L/min
Standard Error 4.367
|
59.412 L/min
Standard Error 4.370
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29Population: FAS
Adjusted means of the FEV1 measurements \[L\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint -1:00 hr response
|
1.410 Litres
Standard Error 0.018
|
1.464 Litres
Standard Error 0.018
|
1.481 Litres
Standard Error 0.018
|
1.491 Litres
Standard Error 0.018
|
1.414 Litres
Standard Error 0.018
|
1.467 Litres
Standard Error 0.018
|
1.504 Litres
Standard Error 0.018
|
1.500 Litres
Standard Error 0.018
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint -0:10 hr response
|
1.431 Litres
Standard Error 0.020
|
1.487 Litres
Standard Error 0.020
|
1.488 Litres
Standard Error 0.020
|
1.516 Litres
Standard Error 0.020
|
1.447 Litres
Standard Error 0.020
|
1.498 Litres
Standard Error 0.020
|
1.526 Litres
Standard Error 0.020
|
1.527 Litres
Standard Error 0.020
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 0:00 hr response
|
1.419 Litres
Standard Error 0.018
|
1.473 Litres
Standard Error 0.018
|
1.484 Litres
Standard Error 0.018
|
1.503 Litres
Standard Error 0.018
|
1.431 Litres
Standard Error 0.018
|
1.482 Litres
Standard Error 0.018
|
1.514 Litres
Standard Error 0.018
|
1.511 Litres
Standard Error 0.018
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 0:05 hr response
|
1.483 Litres
Standard Error 0.022
|
1.555 Litres
Standard Error 0.022
|
1.553 Litres
Standard Error 0.022
|
1.563 Litres
Standard Error 0.022
|
1.491 Litres
Standard Error 0.022
|
1.576 Litres
Standard Error 0.022
|
1.593 Litres
Standard Error 0.022
|
1.601 Litres
Standard Error 0.022
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 0:30 hr response
|
1.516 Litres
Standard Error 0.021
|
1.570 Litres
Standard Error 0.021
|
1.597 Litres
Standard Error 0.021
|
1.630 Litres
Standard Error 0.021
|
1.524 Litres
Standard Error 0.021
|
1.605 Litres
Standard Error 0.021
|
1.643 Litres
Standard Error 0.021
|
1.660 Litres
Standard Error 0.021
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 1:00 hr response
|
1.521 Litres
Standard Error 0.021
|
1.595 Litres
Standard Error 0.021
|
1.622 Litres
Standard Error 0.021
|
1.633 Litres
Standard Error 0.021
|
1.527 Litres
Standard Error 0.021
|
1.627 Litres
Standard Error 0.021
|
1.658 Litres
Standard Error 0.021
|
1.675 Litres
Standard Error 0.021
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 2:00 hr response
|
1.552 Litres
Standard Error 0.021
|
1.625 Litres
Standard Error 0.021
|
1.656 Litres
Standard Error 0.021
|
1.687 Litres
Standard Error 0.022
|
1.556 Litres
Standard Error 0.021
|
1.661 Litres
Standard Error 0.021
|
1.699 Litres
Standard Error 0.021
|
1.711 Litres
Standard Error 0.021
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 3:00 hr response
|
1.553 Litres
Standard Error 0.022
|
1.648 Litres
Standard Error 0.022
|
1.659 Litres
Standard Error 0.022
|
1.671 Litres
Standard Error 0.022
|
1.567 Litres
Standard Error 0.022
|
1.671 Litres
Standard Error 0.022
|
1.690 Litres
Standard Error 0.022
|
1.716 Litres
Standard Error 0.022
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 4:00 hr response
|
1.543 Litres
Standard Error 0.021
|
1.621 Litres
Standard Error 0.021
|
1.654 Litres
Standard Error 0.021
|
1.659 Litres
Standard Error 0.021
|
1.563 Litres
Standard Error 0.021
|
1.663 Litres
Standard Error 0.021
|
1.676 Litres
Standard Error 0.021
|
1.708 Litres
Standard Error 0.021
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 5:00 hr response
|
1.549 Litres
Standard Error 0.021
|
1.622 Litres
Standard Error 0.021
|
1.626 Litres
Standard Error 0.021
|
1.654 Litres
Standard Error 0.021
|
1.540 Litres
Standard Error 0.021
|
1.640 Litres
Standard Error 0.021
|
1.655 Litres
Standard Error 0.021
|
1.688 Litres
Standard Error 0.021
|
|
Individual FEV1 Measurements at Each Time Point on Day 29
Timepoint 6:00 hr response
|
1.517 Litres
Standard Error 0.022
|
1.605 Litres
Standard Error 0.022
|
1.631 Litres
Standard Error 0.021
|
1.647 Litres
Standard Error 0.022
|
1.547 Litres
Standard Error 0.022
|
1.636 Litres
Standard Error 0.022
|
1.656 Litres
Standard Error 0.022
|
1.687 Litres
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29Population: FAS
Adjusted means of the FVC measurements \[L\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint -1:00 hr response
|
2.877 Litres
Standard Error 0.029
|
2.961 Litres
Standard Error 0.029
|
2.996 Litres
Standard Error 0.029
|
2.954 Litres
Standard Error 0.029
|
2.877 Litres
Standard Error 0.029
|
3.006 Litres
Standard Error 0.029
|
3.012 Litres
Standard Error 0.029
|
3.007 Litres
Standard Error 0.029
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint -0:10 hr response
|
2.891 Litres
Standard Error 0.032
|
3.007 Litres
Standard Error 0.032
|
3.009 Litres
Standard Error 0.031
|
3.012 Litres
Standard Error 0.032
|
2.904 Litres
Standard Error 0.032
|
3.036 Litres
Standard Error 0.032
|
3.032 Litres
Standard Error 0.032
|
3.032 Litres
Standard Error 0.032
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 0:00 hr response
|
2.882 Litres
Standard Error 0.029
|
2.981 Litres
Standard Error 0.029
|
3.002 Litres
Standard Error 0.029
|
2.982 Litres
Standard Error 0.029
|
2.889 Litres
Standard Error 0.029
|
3.020 Litres
Standard Error 0.029
|
3.020 Litres
Standard Error 0.029
|
3.016 Litres
Standard Error 0.029
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 0:05 hr response
|
2.999 Litres
Standard Error 0.033
|
3.130 Litres
Standard Error 0.033
|
3.120 Litres
Standard Error 0.033
|
3.087 Litres
Standard Error 0.033
|
3.009 Litres
Standard Error 0.033
|
3.141 Litres
Standard Error 0.033
|
3.147 Litres
Standard Error 0.033
|
3.148 Litres
Standard Error 0.033
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 0:30 hr response
|
3.018 Litres
Standard Error 0.033
|
3.171 Litres
Standard Error 0.033
|
3.145 Litres
Standard Error 0.033
|
3.172 Litres
Standard Error 0.034
|
3.019 Litres
Standard Error 0.033
|
3.190 Litres
Standard Error 0.034
|
3.192 Litres
Standard Error 0.033
|
3.219 Litres
Standard Error 0.033
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 1:00 hr response
|
3.036 Litres
Standard Error 0.034
|
3.174 Litres
Standard Error 0.034
|
3.190 Litres
Standard Error 0.034
|
3.162 Litres
Standard Error 0.034
|
3.032 Litres
Standard Error 0.034
|
3.204 Litres
Standard Error 0.034
|
3.215 Litres
Standard Error 0.034
|
3.239 Litres
Standard Error 0.034
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 2:00 hr response
|
3.077 Litres
Standard Error 0.034
|
3.216 Litres
Standard Error 0.034
|
3.234 Litres
Standard Error 0.034
|
3.208 Litres
Standard Error 0.035
|
3.071 Litres
Standard Error 0.034
|
3.258 Litres
Standard Error 0.035
|
3.249 Litres
Standard Error 0.034
|
3.275 Litres
Standard Error 0.034
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 3:00 hr response
|
3.067 Litres
Standard Error 0.035
|
3.222 Litres
Standard Error 0.035
|
3.233 Litres
Standard Error 0.035
|
3.200 Litres
Standard Error 0.036
|
3.081 Litres
Standard Error 0.035
|
3.264 Litres
Standard Error 0.036
|
3.267 Litres
Standard Error 0.035
|
3.303 Litres
Standard Error 0.035
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 4:00 hr response
|
3.054 Litres
Standard Error 0.035
|
3.181 Litres
Standard Error 0.035
|
3.204 Litres
Standard Error 0.034
|
3.183 Litres
Standard Error 0.035
|
3.054 Litres
Standard Error 0.034
|
3.266 Litres
Standard Error 0.035
|
3.227 Litres
Standard Error 0.035
|
3.281 Litres
Standard Error 0.035
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 5:00 hr response
|
3.061 Litres
Standard Error 0.035
|
3.193 Litres
Standard Error 0.035
|
3.188 Litres
Standard Error 0.035
|
3.178 Litres
Standard Error 0.035
|
3.019 Litres
Standard Error 0.035
|
3.222 Litres
Standard Error 0.035
|
3.214 Litres
Standard Error 0.035
|
3.252 Litres
Standard Error 0.035
|
|
Individual FVC Measurements at Each Time Point on Day 29
Timepoint 6:00 hr response
|
3.035 Litres
Standard Error 0.035
|
3.163 Litres
Standard Error 0.035
|
3.197 Litres
Standard Error 0.035
|
3.179 Litres
Standard Error 0.035
|
3.028 Litres
Standard Error 0.035
|
3.228 Litres
Standard Error 0.035
|
3.208 Litres
Standard Error 0.035
|
3.261 Litres
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29Population: FAS
Adjusted means of the PEF measurements \[L/min\] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint -1:00 hr response
|
246.557 L/min
Standard Error 4.061
|
260.901 L/min
Standard Error 4.064
|
263.662 L/min
Standard Error 4.037
|
269.754 L/min
Standard Error 4.110
|
249.356 L/min
Standard Error 4.054
|
263.134 L/min
Standard Error 4.092
|
267.013 L/min
Standard Error 4.064
|
266.913 L/min
Standard Error 4.067
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint -0:10 hr response
|
245.661 L/min
Standard Error 4.165
|
264.412 L/min
Standard Error 4.180
|
265.177 L/min
Standard Error 4.139
|
271.793 L/min
Standard Error 4.204
|
253.921 L/min
Standard Error 4.157
|
264.808 L/min
Standard Error 4.211
|
268.772 L/min
Standard Error 4.168
|
266.506 L/min
Standard Error 4.183
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 0:00 hr response
|
245.758 L/min
Standard Error 3.892
|
262.239 L/min
Standard Error 3.895
|
264.202 L/min
Standard Error 3.870
|
270.565 L/min
Standard Error 3.926
|
251.517 L/min
Standard Error 3.886
|
263.757 L/min
Standard Error 3.921
|
267.623 L/min
Standard Error 3.895
|
266.187 L/min
Standard Error 3.898
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 0:05 hr response
|
254.967 L/min
Standard Error 4.259
|
267.969 L/min
Standard Error 4.272
|
273.340 L/min
Standard Error 4.235
|
275.329 L/min
Standard Error 4.307
|
259.301 L/min
Standard Error 4.252
|
271.071 L/min
Standard Error 4.289
|
276.004 L/min
Standard Error 4.262
|
275.727 L/min
Standard Error 4.275
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 0:30 hr response
|
257.326 L/min
Standard Error 4.548
|
275.045 L/min
Standard Error 4.563
|
279.309 L/min
Standard Error 4.519
|
286.288 L/min
Standard Error 4.603
|
264.909 L/min
Standard Error 4.539
|
280.836 L/min
Standard Error 4.582
|
287.502 L/min
Standard Error 4.550
|
288.289 L/min
Standard Error 4.566
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 1:00 hr response
|
261.890 L/min
Standard Error 4.420
|
279.892 L/min
Standard Error 4.434
|
287.635 L/min
Standard Error 4.393
|
289.866 L/min
Standard Error 4.472
|
263.293 L/min
Standard Error 4.412
|
283.326 L/min
Standard Error 4.452
|
288.427 L/min
Standard Error 4.422
|
288.585 L/min
Standard Error 4.437
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 2:00 hr response
|
269.187 L/min
Standard Error 4.606
|
287.181 L/min
Standard Error 4.621
|
295.820 L/min
Standard Error 4.578
|
300.076 L/min
Standard Error 4.661
|
272.318 L/min
Standard Error 4.597
|
291.503 L/min
Standard Error 4.640
|
298.394 L/min
Standard Error 4.609
|
294.627 L/min
Standard Error 4.625
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 3:00 hr response
|
269.067 L/min
Standard Error 4.649
|
292.962 L/min
Standard Error 4.665
|
296.736 L/min
Standard Error 4.620
|
303.099 L/min
Standard Error 4.707
|
274.334 L/min
Standard Error 4.641
|
295.008 L/min
Standard Error 4.685
|
296.641 L/min
Standard Error 4.652
|
300.582 L/min
Standard Error 4.669
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 4:00 hr response
|
266.451 L/min
Standard Error 4.485
|
286.382 L/min
Standard Error 4.499
|
297.483 L/min
Standard Error 4.460
|
297.415 L/min
Standard Error 4.536
|
274.466 L/min
Standard Error 4.478
|
293.986 L/min
Standard Error 4.517
|
293.617 L/min
Standard Error 4.488
|
302.539 L/min
Standard Error 4.502
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 5:00 hr response
|
272.141 L/min
Standard Error 4.500
|
287.917 L/min
Standard Error 4.514
|
293.878 L/min
Standard Error 4.474
|
295.911 L/min
Standard Error 4.550
|
269.220 L/min
Standard Error 4.492
|
293.039 L/min
Standard Error 4.531
|
294.713 L/min
Standard Error 4.502
|
300.335 L/min
Standard Error 4.517
|
|
Individual PEF Measurements at Each Time Point on Day 29
Timepoint 6:00 hr response
|
268.680 L/min
Standard Error 4.523
|
284.028 L/min
Standard Error 4.537
|
295.843 L/min
Standard Error 4.497
|
295.703 L/min
Standard Error 4.575
|
270.707 L/min
Standard Error 4.515
|
290.283 L/min
Standard Error 4.556
|
293.466 L/min
Standard Error 4.526
|
299.234 L/min
Standard Error 4.541
|
SECONDARY outcome
Timeframe: Weeks 1 and 4Population: FAS
Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol \[albuterol\] dose (100 mcg per puff).
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Weekly Mean Number of Puffs of Rescue Medication Used Per Day
Week 4
|
1.391 number of puffs per day
Standard Error 0.164
|
1.502 number of puffs per day
Standard Error 0.163
|
1.299 number of puffs per day
Standard Error 0.163
|
1.444 number of puffs per day
Standard Error 0.164
|
1.561 number of puffs per day
Standard Error 0.162
|
1.344 number of puffs per day
Standard Error 0.165
|
1.198 number of puffs per day
Standard Error 0.164
|
1.315 number of puffs per day
Standard Error 0.163
|
|
Weekly Mean Number of Puffs of Rescue Medication Used Per Day
Week 1
|
1.511 number of puffs per day
Standard Error 0.146
|
1.298 number of puffs per day
Standard Error 0.145
|
1.191 number of puffs per day
Standard Error 0.147
|
1.446 number of puffs per day
Standard Error 0.147
|
1.423 number of puffs per day
Standard Error 0.145
|
1.465 number of puffs per day
Standard Error 0.147
|
1.172 number of puffs per day
Standard Error 0.146
|
1.244 number of puffs per day
Standard Error 0.146
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: FAS
Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29. The score was evaluated on a 8-points scale : * Poor : 1,2 * Fair : 3,4 * Good : 5,6 * Excellent : 7,8
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Physicians Global Evaluation
Day 1
|
4.618 units on a scale
Standard Error 0.090
|
4.631 units on a scale
Standard Error 0.090
|
4.484 units on a scale
Standard Error 0.089
|
4.579 units on a scale
Standard Error 0.091
|
4.747 units on a scale
Standard Error 0.090
|
4.464 units on a scale
Standard Error 0.091
|
4.634 units on a scale
Standard Error 0.090
|
4.690 units on a scale
Standard Error 0.090
|
|
Physicians Global Evaluation
Day 29
|
4.985 units on a scale
Standard Error 0.093
|
5.146 units on a scale
Standard Error 0.091
|
5.248 units on a scale
Standard Error 0.091
|
5.070 units on a scale
Standard Error 0.094
|
5.109 units on a scale
Standard Error 0.092
|
5.280 units on a scale
Standard Error 0.093
|
5.165 units on a scale
Standard Error 0.092
|
5.227 units on a scale
Standard Error 0.092
|
SECONDARY outcome
Timeframe: Day 29Population: FAS
Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29. 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
Outcome measures
| Measure |
Olo 5
n=107 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=107 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=109 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=104 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=107 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Patients Global Rating
|
3.357 units on a scale
Standard Error 0.102
|
3.135 units on a scale
Standard Error 0.102
|
2.916 units on a scale
Standard Error 0.102
|
3.208 units on a scale
Standard Error 0.104
|
3.262 units on a scale
Standard Error 0.102
|
2.880 units on a scale
Standard Error 0.103
|
3.130 units on a scale
Standard Error 0.102
|
2.936 units on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline and 30 min post-dose on day 29Population: TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.
Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).
Outcome measures
| Measure |
Olo 5
n=105 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=111 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=106 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=106 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=108 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Pulse Rate Recorded in Conjunction With Spirometry
|
-2.4 bpm
Standard Deviation 10.4
|
-2.8 bpm
Standard Deviation 10.3
|
-3.1 bpm
Standard Deviation 10.3
|
-1.8 bpm
Standard Deviation 9.5
|
-2.1 bpm
Standard Deviation 8.5
|
-3.6 bpm
Standard Deviation 9.6
|
-2.4 bpm
Standard Deviation 10.5
|
-1.0 bpm
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline and 30 min post-dose on day 29Population: TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.
Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).
Outcome measures
| Measure |
Olo 5
n=105 Participants
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=105 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=111 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=106 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=108 Participants
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=106 Participants
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=108 Participants
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
|
T+O 5/10
n=107 Participants
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry
Systolic blood pressure
|
-7.2 mmHg
Standard Deviation 15.0
|
-6.0 mmHg
Standard Deviation 12.8
|
-5.6 mmHg
Standard Deviation 15.0
|
-4.8 mmHg
Standard Deviation 13.9
|
-3.4 mmHg
Standard Deviation 14.7
|
-5.5 mmHg
Standard Deviation 15.2
|
-3.8 mmHg
Standard Deviation 14.2
|
-2.2 mmHg
Standard Deviation 13.0
|
|
Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry
Diastolic blood pressure
|
-3.8 mmHg
Standard Deviation 9.1
|
-2.8 mmHg
Standard Deviation 8.6
|
-2.5 mmHg
Standard Deviation 9.8
|
-3.0 mmHg
Standard Deviation 9.8
|
-3.0 mmHg
Standard Deviation 8.6
|
-3.0 mmHg
Standard Deviation 9.1
|
-2.5 mmHg
Standard Deviation 9.7
|
-0.4 mmHg
Standard Deviation 9.2
|
Adverse Events
Olo 5
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
T+O 1.25/5
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
T+O 2.5/5
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
T+O 5/5
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Olo 10
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
T+O 1.25/10
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
T+O 2.5/10
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
T+O 5/10
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olo 5
n=108 participants at risk
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=109 participants at risk
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=113 participants at risk
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=109 participants at risk
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=109 participants at risk
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=110 participants at risk
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=110 participants at risk
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/10
n=111 participants at risk
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
1.8%
2/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Cardiac disorders
Tachycardia
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.91%
1/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.91%
1/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Infections and infestations
Aspergillosis
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.88%
1/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.92%
1/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.88%
1/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.92%
1/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.91%
1/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.91%
1/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.91%
1/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.88%
1/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
1.8%
2/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.88%
1/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
0.00%
0/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
Other adverse events
| Measure |
Olo 5
n=108 participants at risk
Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/5
n=109 participants at risk
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/5
n=113 participants at risk
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/5
n=109 participants at risk
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
Olo 10
n=109 participants at risk
Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
|
T+O 1.25/10
n=110 participants at risk
Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 2.5/10
n=110 participants at risk
Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
T+O 5/10
n=111 participants at risk
Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.2%
11/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
11.0%
12/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
7.1%
8/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
2.8%
3/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
6.4%
7/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
7.3%
8/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
3.6%
4/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
1.8%
2/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.6%
6/108 • From first drug administration until 21 days after the last administration, up to 75 days
|
3.7%
4/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
2.7%
3/113 • From first drug administration until 21 days after the last administration, up to 75 days
|
7.3%
8/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
5.5%
6/109 • From first drug administration until 21 days after the last administration, up to 75 days
|
6.4%
7/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
2.7%
3/110 • From first drug administration until 21 days after the last administration, up to 75 days
|
3.6%
4/111 • From first drug administration until 21 days after the last administration, up to 75 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER