PPAR-gamma: A noval therapeutic target for asthma
- Conditions
- AsthmaMedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
- Registration Number
- EUCTR2008-004112-13-GB
- Lead Sponsor
- ottingham University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Patients aged between 18-75 (Male or Female) with a clinical diagnosis of asthma. With a forecd expiratory volume (FEV) in 1 second 50-90% predicted and an increase in FEV1 >12% following inhaled salbutamol 400µg or peak expiratory flow (PEF) variability >12% during run-in.
Allowed medication:0-800µg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist.
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
Exclusion criteria include current smokers or an ex-smoker with >10 pack years smoking history. Treatment with leukatriene antagonists, liver or cardiovascular disease, oral steroid treatment or exacerbation within 6 weeks. Females who are pregnant, lactating or not using adequate contraception. Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepactic impairment, diabetic ketoacidosis), oral or insulin treatment for diabetes, treatment with gemfibrozil or rifampicin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Forced expiratory volume in 1 second after 12 weeks;Main Objective: To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma;Secondary Objective: To determine the effects of treating patients with asthma with pioglitazone in terms of asthma symptoms, peak flow, asthma control and quality of life, exhaled nitric oxide, bronchial hper-responsiveness, induced sputum cell counts and analysis.
- Secondary Outcome Measures
Name Time Method