Asthma
Conditions
Brief summary
To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.
Interventions
OTHERplacebo
placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks
DRUGIMP Pioglitozone
Pioglitazone 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 of either sex with a clinical diagnosis of asthma, * FEV1 ≥ 60% predicted and an increase in FEV1 of greater than 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.
Exclusion criteria
* Current smoking, * \> 10 pack years smoking history, * Treatment with leukotriene 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, hepatic impairment, diabetic ketoacidosis), * Oral or insulin treatment for diabetes, * Treatment with gemfibrozil or rifampicin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 after 12 weeks treatment | week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms | 12 weeks | Change over 12 weeks in daily asthma symptoms, mean morning and evening PEF, Juniper asthma control questionnaire and asthma quality of life questionnaire scores, exhaled nitric oxide level, bronchial hyper-responsiveness, induced sputum cell counts and analysis detailed above, adverse effects |
Countries
United Kingdom
Outcome results
None listed