Effect of Pioglitazone on Inflammation in Cystic Fibrosis

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul Beringer
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Age greater than 18 years

• Clinically stable (FEV1 within 10% of baseline)

• FEV1 > 40% predicted

Exclusion Criteria:

• 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