PPAR-gamma: a Novel Therapeutic Target for Asthma?

Phase 4

Terminated

• Conditions: Asthma
• Interventions: Drug: IMP Pioglitozone; Other: placebo

• Registration Number: NCT01134835
• Lead Sponsor: University of Nottingham

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-28
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2012-02
• Study Completion: 2012-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMP Pioglitazone	IMP 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.
Placebo	placebo	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.

Primary Outcome Measures

Name	Time	Method
FEV1 after 12 weeks treatment	week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom