PPAR-gamma: A noval therapeutic target for asthma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004112-13-GB

Enrollment

100

Registered

2008-07-16

Start date

2009-06-26

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Actos Pharmaceutical Form: Over encapsulated tablet CAS Number: 111025-46-8 Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged between 18-75 (Male or Female) with a clinical diagnosis of asthma. With a forecd expiratory volume (FEV) in 1 second 50-90% predicted and an increase in FEV1 >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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria include current smokers or an ex-smoker with >10 pack years smoking history. Treatment with leukatriene 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, hepactic impairment, diabetic ketoacidosis), oral or insulin treatment for diabetes, treatment with gemfibrozil or rifampicin.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Forced expiratory volume in 1 second after 12 weeks;Main Objective: To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma;Secondary Objective: To determine the effects of treating patients with asthma with pioglitazone in terms of asthma symptoms, peak flow, asthma control and quality of life, exhaled nitric oxide, bronchial hper-responsiveness, induced sputum cell counts and analysis.	—

Measure

Time frame

Primary end point(s): Forced expiratory volume in 1 second after 12 weeks;Main Objective: To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma;Secondary Objective: To determine the effects of treating patients with asthma with pioglitazone in terms of asthma symptoms, peak flow, asthma control and quality of life, exhaled nitric oxide, bronchial hper-responsiveness, induced sputum cell counts and analysis.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026