PPAR-gamma: a Novel Therapeutic Target for Asthma?

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Treatments: Pioglitazone

Criteria

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.