Back to resultsPPAR-gamma: a Novel Therapeutic Target for Asthma?
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
placebo
IMP Pioglitozone
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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.
Sites / Locations
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IMP Pioglitazone
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
FEV1 after 12 weeks treatment
Secondary Outcome Measures
Change in symptoms
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
Full Information
NCT ID
NCT01134835
First Posted
May 28, 2010
Last Updated
December 1, 2015
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT01134835
Brief Title
PPAR-gamma: a Novel Therapeutic Target for Asthma?
Official Title
PPAR-gamma: a Novel Therapeutic Target in Asthma?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
safety concerns with pioglitazone
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMP Pioglitazone
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
IMP Pioglitozone
Intervention 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.
Primary Outcome Measure Information:
Title
FEV1 after 12 weeks treatment
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change in symptoms
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27560168
Citation
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.
Results Reference
derived
Learn more about this trial
PPAR-gamma: a Novel Therapeutic Target for Asthma?
We'll reach out to this number within 24 hrs