A study to compare the efficacy and safety of different dosings of olodaterol administered with the Respimat® Inhaler in patients with moderate to severe asthma

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2 actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] and Placebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg], Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administration in Patients with Moderate to Severe Persistent Asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006625-14-DE

Enrollment

180

Registered

2010-12-09

Start date

2011-02-23

Completion date

Unknown

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe persistent asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: BI 1744 2.5 µg Solution for Inhalation Product Code: BI 1744 CL Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Olodaterol Current Sponsor code: BI 1744 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of either sex; aged =18 = 70 years; a current diagnosis and a documented minimum 3 month history of asthma (GINA treatment steps 3 and 4); prebronchodilator FEV1=60% predicted and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years), upper respiratory tract infection in the past 4 weeks prior to screening visit 1b, oral or other systemic corticosteroids in the past 6 weeks; patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to compare the 24-hour FEV1-time profile of olodaterol versus placebo after 3 weeks of once daily (5 µg, 10 µg) or twice daily (2.5 µg and 5 µg) olodaterol inhalation solution administration with the Respimat® Inhaler. ;Secondary Objective: Secondary objective is to conduct an exploratory comparison between the different active treatments.;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint will be AUC 0-24h response after three weeks of treatment.;Timepoint(s) of evaluation of this end point: After each three weeks of treatment	—

Measure

Time frame

Main Objective: The primary objective of the trial is to compare the 24-hour FEV1-time profile of olodaterol versus placebo after 3 weeks of once daily (5 µg, 10 µg) or twice daily (2.5 µg and 5 µg) olodaterol inhalation solution administration with the Respimat® Inhaler. ;Secondary Objective: Secondary objective is to conduct an exploratory comparison between the different active treatments.;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint will be AUC 0-24h response after three weeks of treatment.;Timepoint(s) of evaluation of this end point: After each three weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): KEY SECONDARY ENDPOINT: 1. The key secondary efficacy endpoints will be FEV1 AUC0-12 h and FEV1 AUC12-24 h response after 3 weeks of treatment. OTHER SECONDARY ENDPOINTS 2. Peak expiratory flow (PEF) a.m. and p.m. (L/min) measured by patients at home using the AM3® device (weekly and overall means obtained will be compared). 3. Peak FEV1 (L) (within 24 hours post-dose) measured following the morning trial-drug inhalation at the end of each 3 week period of randomised treatment. 4. Trough FEV1 (L) at the end of each 3 week treatment period. Trough FEV1 (L) at the end of each 3 week treatment period. Trough FEV1 is defined as the mean of the two FEV1 values (performed at 23:00 and 23:50 hours after the last morning trial-drug inhalation) at the end of the dosing interval. 5. Trough forced vital capacity (FVC) (L) at the end of each dosing interval (as defined above for FEV1) determined at the end of each 3 week period of randomised treatment. 6. FVC (AUC0-12h) and FVC (AUC12-24h) response and peak FVC (L) (within 24 hours post-dose) measured following each dosing determined at the end of each 3 week treatment period. 7. PEF (AUC0-12 h), PEF (AUC12-24 h) and PEF (AUC0-24 h) response and peak PEF (L/min) (within 24 hours post-dose) measured following each dosing determined at the end of each 3 week treatment period. 8. PEF (home measured) variability: PEF variability (L/min) is the absolute difference between morning and evening PEF value divided by the mean of these two values (weekly and overall means obtained after each period of randomised treatment will be compared). 9. Use of PRN salbutamol (albuterol) rescue medication during the entire study period.: Number of puffs of rescue therapy used per day (i.e. the full 24 hour period, the daytime and the night time evaluated separately and together; weekly and overall means obtained each period of randomised treatment will be compared). 10. Control of asthma as assessed by	—

Measure

Time frame

Secondary end point(s): KEY SECONDARY ENDPOINT: 1. The key secondary efficacy endpoints will be FEV1 AUC0-12 h and FEV1 AUC12-24 h response after 3 weeks of treatment. OTHER SECONDARY ENDPOINTS 2. Peak expiratory flow (PEF) a.m. and p.m. (L/min) measured by patients at home using the AM3® device (weekly and overall means obtained will be compared). 3. Peak FEV1 (L) (within 24 hours post-dose) measured following the morning trial-drug inhalation at the end of each 3 week period of randomised treatment. 4. Trough FEV1 (L) at the end of each 3 week treatment period. Trough FEV1 (L) at the end of each 3 week treatment period. Trough FEV1 is defined as the mean of the two FEV1 values (performed at 23:00 and 23:50 hours after the last morning trial-drug inhalation) at the end of the dosing interval. 5. Trough forced vital capacity (FVC) (L) at the end of each dosing interval (as defined above for FEV1) determined at the end of each 3 week period of randomised treatment. 6. FVC (AUC0-12h) and FVC (AUC12-24h) response and peak FVC (L) (within 24 hours post-dose) measured following each dosing determined at the end of each 3 week treatment period. 7. PEF (AUC0-12 h), PEF (AUC12-24 h) and PEF (AUC0-24 h) response and peak PEF (L/min) (within 24 hours post-dose) measured following each dosing determined at the end of each 3 week treatment period. 8. PEF (home measured) variability: PEF variability (L/min) is the absolute difference between morning and evening PEF value divided by the mean of these two values (weekly and overall means obtained after each period of randomised treatment will be compared). 9. Use of PRN salbutamol (albuterol) rescue medication during the entire study period.: Number of puffs of rescue therapy used per day (i.e. the full 24 hour period, the daytime and the night time evaluated separately and together; weekly and overall means obtained each period of randomised treatment will be compared). 10. Control of asthma as assessed by

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Countries

Austria, Germany, Hungary, Slovakia, Slovenia, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026