PPAR-gamma: a Novel Therapeutic Target for Asthma?

This study has been terminated.
(safety concerns with pioglitazone)
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
First received: May 28, 2010
Last updated: October 4, 2012
Last verified: October 2012
To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.

Condition Intervention Phase
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PPAR-gamma: a Novel Therapeutic Target in Asthma?

Resource links provided by NLM:

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • FEV1 after 12 weeks treatment [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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

Enrollment: 68
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMP
Drug: 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.
Placebo Comparator: Placebo


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01134835

United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01134835     History of Changes
Other Study ID Numbers: 08028
Study First Received: May 28, 2010
Last Updated: October 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2015