Trial record 5 of 6 for:    asthma pioglitazone

PPAR-gamma: a Novel Therapeutic Target for Asthma?

This study has been terminated.
(safety concerns with pioglitazone)
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01134835
First received: May 28, 2010
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.


Condition Intervention Phase
Asthma
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
Pioglizatone
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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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:
Asthma
Pioglitazone
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014