Study Stopped
safety concerns with pioglitazone
PPAR-gamma: a Novel Therapeutic Target for Asthma?
1 other identifier
interventional
68
1 country
1
Brief Summary
To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Jun 2010
Typical duration for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 3, 2015
December 1, 2015
1.7 years
May 28, 2010
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
FEV1 after 12 weeks treatment
week 12
Secondary Outcomes (1)
Change in symptoms
12 weeks
Study Arms (2)
IMP Pioglitazone
EXPERIMENTALPioglitazone 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 COMPARATORPlacebo 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Related Publications (1)
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.
PMID: 27560168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
June 1, 2010
Primary Completion
February 1, 2012
Study Completion
July 1, 2012
Last Updated
December 3, 2015
Record last verified: 2015-12