Trial Outcomes & Findings for Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients (NCT NCT02629965)
NCT ID: NCT02629965
Last Updated: 2019-06-06
Results Overview
At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
COMPLETED
PHASE3
184 participants
Day 43, 60 minutes post-dose after 6 weeks of each treatment
2019-06-06
Participant Flow
This was a randomised, double-blind, active-controlled, 2-way crossover trial to assess the effects of once daily treatment of orally inhaled Tiotropium + Olodaterol FDC 5 μg/5 μg or Tiotropium 5 μg over 12 weeks of treatment in Japanese patients with Chronic obstructive pulmonary disease (COPD).
All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Tiotropium 5 μg / Tiotropium + Olodaterol 5/5 μg FDC
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) in period 1 and Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks
2 treatments were not separated by wash-out periods.
|
Tiotropium + Olodaterol 5/5 μg FDC / Tiotropium 5 μg
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 1 and Tiotropium inhalation solution (2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks.
2 treatments were not separated by wash-out periods.
|
|---|---|---|
|
Period 1
STARTED
|
92
|
92
|
|
Period 1
COMPLETED
|
88
|
90
|
|
Period 1
NOT COMPLETED
|
4
|
2
|
|
Period 2
STARTED
|
88
|
90
|
|
Period 2
COMPLETED
|
87
|
90
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tiotropium 5 μg / Tiotropium + Olodaterol 5/5 μg FDC
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) in period 1 and Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks
2 treatments were not separated by wash-out periods.
|
Tiotropium + Olodaterol 5/5 μg FDC / Tiotropium 5 μg
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) in period 1 and Tiotropium inhalation solution (2.5 microgram per actuation) in period 2 once a day in the morning for a total of 12 weeks.
2 treatments were not separated by wash-out periods.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 1
Unexpected worsening of disease
|
2
|
0
|
|
Period 1
Other than listed above
|
1
|
2
|
|
Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
Baseline characteristics by cohort
| Measure |
Total
n=184 Participants
Total randomised participants in the trial.
|
|---|---|
|
Age, Continuous
|
72.8 Years
STANDARD_DEVIATION 7.1 • n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
Asian
|
184 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated set (TS): TS includes patients who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint.
|
PRIMARY outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=178 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
|
1.875 Litre (L)
Standard Error 0.019
|
1.990 Litre (L)
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
6-minute walk distance \[Meter\] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=178 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=178 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
6-minute Walk Distance [Meter]
|
307.356 Meter (m)
Standard Error 5.170
|
311.524 Meter (m)
Standard Error 5.170
|
SECONDARY outcome
Timeframe: 2 weeks prior to Week 6 per treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of average number of step per day \[step/day\] treatment comparisons in measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Average Number of Step Per Day (Step/Day)
|
3550.400 step/day
Standard Error 93.123
|
3559.901 step/day
Standard Error 93.460
|
SECONDARY outcome
Timeframe: 2 weeks prior to Week 6 per treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of average daily duration \[minute\] of ≥ 4 METs treatment comparisons measured by the activity monitor in the 2 weeks prior to week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=177 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)
|
10.206 minute
Standard Error 0.497
|
9.914 minute
Standard Error 0.499
|
SECONDARY outcome
Timeframe: 2 weeks prior to Week 6 per treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of average daily duration \[minute\] of ≥ 3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=177 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)
|
44.662 minute
Standard Error 0.979
|
45.601 minute
Standard Error 0.979
|
SECONDARY outcome
Timeframe: 2 weeks prior to Week 6 per treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of average daily duration \[minute\] of ≥ 2 METs treatment comparison measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=177 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)
|
171.935 minute
Standard Error 2.506
|
174.192 minute
Standard Error 2.517
|
SECONDARY outcome
Timeframe: 2 weeks prior to Week 6 per treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of average daily active strength \[METs x minute\] of \>=3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=177 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs
|
148.647 Metabolic equivalents * minutes
Standard Error 3.723
|
151.067 Metabolic equivalents * minutes
Standard Error 3.737
|
SECONDARY outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of 60 minute post-dose slow vital capacity \[Litre\] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=178 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)
|
2.962 Litre (L)
Standard Error 0.021
|
3.096 Litre (L)
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Day 43, 30 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of 30 minute post-dose forced expiratory volume in one second (FEV1) \[Litre\] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=180 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)
|
1.169 Litre (L)
Standard Error 0.011
|
1.275 Litre (L)
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Day 43, 30 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (SE) of 30 minute post-dose forced vital capacity (FVC) \[Litre\] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=180 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=179 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)
|
2.857 Litre (L)
Standard Error 0.021
|
3.020 Litre (L)
Standard Error 0.021
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] test comparisons after 6 weeks of each treatment for 6MWT completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=119 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=121 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Treatment Period
|
1.940 Litre (L)
Standard Error 0.022
|
2.072 Litre (L)
Standard Error 0.022
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] test comparisons after 6 weeks of each treatment for 6MWT completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=128 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=128 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Baseline Period
|
1.925 Litre (L)
Standard Error 0.021
|
2.053 Litre (L)
Standard Error 0.021
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] test comparisons after 6 weeks of each treatment for 6MWT in-completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=59 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=58 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Test Comparisons of 6-Minute Walk Treatment (6MWT) in-Completer at Treatment Period
|
1.738 Litre (L)
Standard Error 0.024
|
1.820 Litre (L)
Standard Error 0.024
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] test comparisons after 6 weeks of each test for 6MWT in-completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=50 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=51 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) in-Completer at Baseline Period
|
1.744 Litre (L)
Standard Error 0.026
|
1.830 Litre (L)
Standard Error 0.026
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage I/II. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=97 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=97 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage I/II
|
2.023 Litre (L)
Standard Error 0.023
|
2.106 Litre (L)
Standard Error 0.023
|
POST_HOC outcome
Timeframe: Day 43, 60 minutes post-dose after 6 weeks of each treatmentPopulation: Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.
At day 43 adjusted mean (standard error) of inspiratory capacity \[Litre\] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage III/IV. Adjusted mean was entered instead of mean in statistical analysis.
Outcome measures
| Measure |
Tiotropium 5 μg
n=81 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium inhalation solution (2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=82 Participants
Participants inhaled 2 puffs from the RESPIMAT Inhaler of the Tiotropium + Olodaterol inhalation solution (2.5/2.5 microgram per actuation) once a day in the morning for 2 periods for 6 weeks.
|
|---|---|---|
|
Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III/IV
|
1.697 Litre (L)
Standard Error 0.026
|
1.849 Litre (L)
Standard Error 0.026
|
Adverse Events
Tiotropium 5
Tiotropium + Olodaterol 5/5
Serious adverse events
| Measure |
Tiotropium 5
n=182 participants at risk
Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium fixed dose combination of 2.5 μg per actuation once a day in the morning for 6 weeks.
|
Tiotropium + Olodaterol 5/5
n=180 participants at risk
Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium + Olodaterol fixed dose combination of 2.5/2.5 μg per actuation once a day in the morning for 6 weeks.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Infections and infestations
Bronchitis
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Infections and infestations
Pneumonia
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage IV
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Renal and urinary disorders
Renal impairment
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
2/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.56%
1/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
|
Vascular disorders
Aortic aneurysm
|
0.55%
1/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
0.00%
0/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
Other adverse events
| Measure |
Tiotropium 5
n=182 participants at risk
Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium fixed dose combination of 2.5 μg per actuation once a day in the morning for 6 weeks.
|
Tiotropium + Olodaterol 5/5
n=180 participants at risk
Participants were orally inhaled 2 puffs from the RESPIMAT Inhaler with the Tiotropium + Olodaterol fixed dose combination of 2.5/2.5 μg per actuation once a day in the morning for 6 weeks.
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.0%
11/182 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
10.0%
18/180 • From first drug administration until 12 weeks after last drug administration, up to 15 weeks
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participants administered a trial medicine.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
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