Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: single dose of 2 mcg; Drug: single dose of 5 mcg; Drug: single dose of 10 mcg; Drug: single dose of 20 mcg; Drug: single dose of 40 mcg; Drug: single dose of placebo

• Registration Number: NCT01809262
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Results First Submitted: 2014-03-28
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Results First Posted: 2014-06-30
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
olodaterol 2 mcg	single dose of 2 mcg	solution for inhalation
olodaterol 5 mcg	single dose of 5 mcg	solution for inhalation
olodaterol 10 mcg	single dose of 10 mcg	solution for inhalation
olodaterol 20 mcg	single dose of 20 mcg	solution for inhalation
olodaterol 40 mcg	single dose of 40 mcg	solution for inhalation
placebo	single dose of placebo	solution for inhalation

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment	24 hours post-dosing	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.

Secondary Outcome Measures

Name	Time	Method
FEV1 AUC 0 - 24 Hours	-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing	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.
FEV1 AUC 0 - 3 Hours	-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing	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.
FEV1 AUC 0 - 12 Hours	-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing	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.
FEV1 AUC 12 - 24 Hours	12h, 14h, 22h, 23h and 24h post-dosing	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.
Peak FEV1 From 0 to 3 Hours	0 to 3 hours post-dosing	Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours	0 to 3 hours post-dosing	Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
Time to Peak Bronchodilator Response	0 to 3 hours post-dosing	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.
Time to Onset of Response	0 to 3 hours post-dosing	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.
Number of Patients Requiring Rescue Medication on a Test-day	Visits 1,2,4,5,6	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.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	2 weeks	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).
Laboratory Testing: Average Change From Baseline of Potassium and Calcium	Baseline and Visit 6	Laboratory testing: Average change from baseline of potassium and calcium measured on test-days

Trial Locations

Locations (1)

1222.3.1 Atrium medisch centrum; 🇳🇱 Heerlen, Netherlands