A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 µg (2 actuations of 2.5 µg) and µg (2 actuations of 5 µg)] of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler as Add-on Therapy in Patients with severe persistent Asthma.
- Conditions
- Patients with severe persistent asthma
- Registration Number
- EUCTR2005-005615-21-NL
- Lead Sponsor
- Boehringer Ingelheim bv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 115
1.Patients (male or female) must have a history of frequent (nocturnal) asthma symptoms (episodic breathlessness, wheezing, chest tightness).
2.Patients must have a 5-yr history of asthma and a current diagnosis of severe, persistent asthma and must meet the following spirometric criteria:
Post bronchodilator (30 min following inhalation of 400 µg salbutamol) FEV1 < 80% of predicted and FEV1 < 70% of FVC (At visit 1).
3.Patients must be symptomatic and at least 6 weeks on a high, stable dose of inhaled corticosteroids + a long-acting beta adrenergic (additional sustained release theophylline and/or leukotriene modifier and/or oral glucocorticosteroids are allowed in stable doses)
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
1.Patients with a significant disease other than asthma (i.e. (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study)
2.Patients with clinically relevant abnormal baseline haematology or blood chemistry will be excluded.
3.Patients with a recent history (i.e., six months or less) of myocardial infarction.
4.Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.
5.Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to demonstrate superiority of lung function response to two doses [5 mcg (2 actuations of 2.5 mcg) and 10 mcg (2 actuations of 5 mcg)] of tiotropium inhalation solution delivered by the Respimat inhaler once daily compared to placebo at the end of the 8-week periods of randomised treatment.;Secondary Objective: To assess the safety of tiotropium add-on therapy in severe asthmatics treated with inhaled steroids and long-acting beta-adrenergics;Primary end point(s): The primary efficacy endpoint is the peak FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period.
- Secondary Outcome Measures
Name Time Method