PPAR-gamma: a Novel Therapeutic Target for Asthma?

Asthma Clinical Trial

Official title:

PPAR-gamma: a Novel Therapeutic Target in Asthma?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134835
• Other study ID #: 08028
• Status: Terminated
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: December 1, 2015
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• placebo
placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 after 12 weeks treatment		week 12	No
Secondary	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	12 weeks	Yes