PPAR-gamma: a Novel Therapeutic Target for Asthma?

University of Nottingham

Status and phase: Terminated; Phase 4

Conditions: Asthma

Treatments: Other: placebo; Drug: IMP Pioglitozone

Study type: Interventional

Funder types: Other

Identifiers

NCT01134835

08028

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

IMP Pioglitazone

Experimental group

Description:

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.

Treatment:

Drug: IMP Pioglitozone

Placebo

Placebo Comparator group

Description:

Placebo 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.

Treatment:

Other: placebo