Phase II, Randomised, Double-Blind, Cross-over Study to Compare the24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered withthe Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] andPlacebo 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 Administrationin Patients with Moderate to Severe Persistent Asthma
- Conditions
- Moderate to severe persistent asthmaMedDRA version: 13.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2008-006625-14-AT
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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 <90% predicted (ECSC); increase in FEV1 =12% and =200 ml 15 min. after 400 µg salbutamol (albuterol); stable on medium to high dose ICS or low to high dose ICS in combination with a LABA for at least 6 weeks prior to screening; stable on ICS mono component of the former fixed
LABA/ICS treatment for at least 48 hours prior to Visit 1b.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to compare the 24-hour FEV1-time profile of<br>olodaterol versus placebo after 3 weeks of once daily (5 µg, 10 µg) or twice daily (2.5<br>µg and 5 µg) olodaterol inhalation solution administration with the Respimat® Inhaler.<br>;Secondary Objective: Secondary objective is to conduct an exploratory comparison between the different<br>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.
- Secondary Outcome Measures
Name Time Method