Trial Outcomes & Findings for Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease (NCT NCT01809262)
NCT ID: NCT01809262
Last Updated: 2014-06-30
Results Overview
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
24 hours post-dosing
Results posted on
2014-06-30
Participant Flow
A Pharmacokinetic sub-study to characterise the pharmacokinetics of 2 μg to 20 μg Olodaterol was planned in a subset of 18 patients. After preliminary evaluation of the data, an open-label extension was planned to investigate the safety, tolerability, and pharmacokinetics of single doses of 40 μg Olodaterol in the 18 patients of the PK sub-study.
This was a randomised, Double-Blind, Placebo-Controlled, 5-Way crossover trial. Each treatment was only administered once in a single dose with a washout period of at least 14 days between treatments.
Participant milestones
| Measure |
Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg
Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg
Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg
Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg
Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg
Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo
Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg
Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo
Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg
Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg
Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
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Period 1 (First Dose + Washout)
STARTED
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4
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Period 1 (First Dose + Washout)
COMPLETED
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Period 1 (First Dose + Washout)
NOT COMPLETED
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0
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0
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0
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0
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1
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0
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0
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0
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Period 2 (Second Dose + Washout)
STARTED
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4
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Period 2 (Second Dose + Washout)
COMPLETED
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Period 2 (Second Dose + Washout)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 3 (Third Dose + Washout)
STARTED
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Period 3 (Third Dose + Washout)
COMPLETED
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Period 3 (Third Dose + Washout)
NOT COMPLETED
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0
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1
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Period 4 (Fourth Dose + Washout)
STARTED
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Period 4 (Fourth Dose + Washout)
COMPLETED
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4
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3
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Period 4 (Fourth Dose + Washout)
NOT COMPLETED
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0
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0
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0
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Period 5 (Fifth Dose + Washout)
STARTED
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4
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3
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Period 5 (Fifth Dose + Washout)
COMPLETED
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4
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4
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Period 5 (Fifth Dose + Washout)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg
Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg
Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg
Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg
Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg
Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo
Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg
Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo
Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg
Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
|
Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg
Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
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|---|---|---|---|---|---|---|---|---|---|---|
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Period 1 (First Dose + Washout)
Adverse Event
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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Period 3 (Third Dose + Washout)
Adverse Event
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Study Total
n=36 Participants
Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
|
|---|---|
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Age, Continuous
|
65.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
|
0.916 L
Standard Error 0.014
|
0.986 L
Standard Error 0.014
|
1.015 L
Standard Error 0.014
|
1.029 L
Standard Error 0.014
|
1.035 L
Standard Error 0.014
|
SECONDARY outcome
Timeframe: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
FEV1 AUC 0 - 3 Hours
|
0.997 L
Standard Error 0.011
|
1.105 L
Standard Error 0.011
|
1.152 L
Standard Error 0.011
|
1.158 L
Standard Error 0.011
|
1.189 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
FEV1 AUC 0 - 12 Hours
|
0.954 L
Standard Error 0.012
|
1.053 L
Standard Error 0.011
|
1.093 L
Standard Error 0.011
|
1.108 L
Standard Error 0.012
|
1.138 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
FEV1 AUC 0 - 24 Hours
|
0.923 L
Standard Error 0.011
|
1.009 L
Standard Error 0.011
|
1.040 L
Standard Error 0.011
|
1.061 L
Standard Error 0.011
|
1.085 L
Standard Error 0.011
|
SECONDARY outcome
Timeframe: 12h, 14h, 22h, 23h and 24h post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
FEV1 AUC 12 - 24 Hours
|
0.891 L
Standard Error 0.012
|
0.965 L
Standard Error 0.012
|
0.987 L
Standard Error 0.012
|
1.014 L
Standard Error 0.012
|
1.032 L
Standard Error 0.012
|
SECONDARY outcome
Timeframe: 0 to 3 hours post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Peak FEV1 From 0 to 3 Hours
|
1.043 L
Standard Error 0.013
|
1.164 L
Standard Error 0.013
|
1.209 L
Standard Error 0.013
|
1.219 L
Standard Error 0.014
|
1.256 L
Standard Error 0.013
|
SECONDARY outcome
Timeframe: 0 to 3 hours post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
|
3.134 L
Standard Error 0.035
|
3.440 L
Standard Error 0.035
|
3.489 L
Standard Error 0.035
|
3.485 L
Standard Error 0.035
|
3.589 L
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 0 to 3 hours post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.
A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Time to Peak Bronchodilator Response
|
102.0 minutes
Standard Deviation 57.4
|
92.6 minutes
Standard Deviation 55.1
|
98.6 minutes
Standard Deviation 53.8
|
83.8 minutes
Standard Deviation 46.6
|
96.9 minutes
Standard Deviation 39.9
|
SECONDARY outcome
Timeframe: 0 to 3 hours post-dosingPopulation: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.
Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Time to Onset of Response
|
148.9 minutes
Standard Deviation 56.2
|
91.5 minutes
Standard Deviation 73.6
|
57.5 minutes
Standard Deviation 68.5
|
59.9 minutes
Standard Deviation 69.6
|
38.2 minutes
Standard Deviation 48.1
|
SECONDARY outcome
Timeframe: Visits 1,2,4,5,6Population: Safety set which consisted of all randomised patients who had taken at least one dose of study medication.
Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Number of Patients Requiring Rescue Medication on a Test-day
|
4 Number of Patients
|
4 Number of Patients
|
0 Number of Patients
|
1 Number of Patients
|
1 Number of Patients
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Safety set
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Outcome measures
| Measure |
Placebo
n=35 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Cardiac disorders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Blood bilirubin increased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.9 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Visit 6Population: Safety set.
Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
Outcome measures
| Measure |
Placebo
n=18 Participants
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=18 Participants
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=17 Participants
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=17 Participants
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=18 Participants
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Potassium (N=17, 18, 17, 17, 18)
|
1.03 mmol/L
Inter-Quartile Range NA • Interval 0.99 to 1.07
|
1.01 mmol/L
Inter-Quartile Range NA • Interval 0.98 to 1.03
|
0.99 mmol/L
Inter-Quartile Range NA • Interval 0.95 to 1.03
|
0.98 mmol/L
Inter-Quartile Range NA • Interval 0.97 to 1.02
|
0.97 mmol/L
Inter-Quartile Range NA • Interval 0.92 to 1.01
|
|
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Calcium (N=18, 18, 17, 17, 18)
|
1.02 mmol/L
Inter-Quartile Range NA • Interval 0.99 to 1.03
|
1.00 mmol/L
Inter-Quartile Range NA • Interval 0.99 to 1.03
|
1.00 mmol/L
Inter-Quartile Range NA • Interval 0.98 to 1.01
|
1.01 mmol/L
Inter-Quartile Range NA • Interval 1.0 to 1.03
|
1.01 mmol/L
Inter-Quartile Range NA • Interval 0.99 to 1.04
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Olo 2 mcg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Olo 5 mcg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Olo 10 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Olo 20 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=35 participants at risk
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 participants at risk
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 participants at risk
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 participants at risk
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 participants at risk
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
5.7%
2/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/34 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/34 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/34 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
Other adverse events
| Measure |
Placebo
n=35 participants at risk
Single dose of matching placebo delivered by the Respimat inhaler.
|
Olo 2 mcg
n=35 participants at risk
Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
|
Olo 5 mcg
n=35 participants at risk
Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
|
Olo 10 mcg
n=34 participants at risk
Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
|
Olo 20 mcg
n=35 participants at risk
Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.6%
3/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/34 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
5.9%
2/34 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
5.7%
2/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/34 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
5.7%
2/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/34 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
0.00%
0/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/35 • 2 weeks
Single dose including washout phase
|
2.9%
1/34 • 2 weeks
Single dose including washout phase
|
5.7%
2/35 • 2 weeks
Single dose including washout phase
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place