safety concerns with pioglitazone

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

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.