Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
68 participants
INTERVENTIONAL
2010-06-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IMP Pioglitazone
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.
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 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 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks
Interventions
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placebo
placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* \> 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.
18 Years
75 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Locations
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Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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Anderson JR, Mortimer K, Pang L, Smith KM, Bailey H, Hodgson DB, Shaw DE, Knox AJ, Harrison TW. Evaluation of the PPAR-gamma Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial. PLoS One. 2016 Aug 25;11(8):e0160257. doi: 10.1371/journal.pone.0160257. eCollection 2016.
Other Identifiers
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08028
Identifier Type: -
Identifier Source: org_study_id