Status:
COMPLETED
Effect of Pioglitazone on Inflammation in Cystic Fibrosis
Lead Sponsor:
Paul Beringer
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of pioglitazone on reducing airway inflammation in cystic fibrosis and characterize the amount and timecourse of pioglitazone elimination from the ...
Detailed Description
Progressive loss of lung function due to chronic infection and inflammation is the primary cause of morbidity and mortality in patients with CF. Current therapies directed at treatment of chronic P. a...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Clinically stable (FEV1 within 10% of baseline)
- FEV1 \> 40% predicted
Exclusion
- History of hypoglycemic events
- Hepatic disease (AST, ALT \> 2.5x ULN)
- Renal disease (GFR \< 60 ml/min - 1.73m2)
- Currently receiving beta-blocker, oral corticosteroids, statin, angiotensin receptor blocker, trimethoprim-sulfamethoxazole, gemfibrozil, or rifampin therapies.
- Allergy to thiazolidinediones
- Pregnancy or attempting to conceive, breast feeding
- Hematocrit \< 30
- Congestive heart failure
- Pulmonary hypertension
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00719381
Start Date
January 1 2008
End Date
June 1 2009
Last Update
June 14 2012
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90089