Effect of Pioglitazone on Inflammation in Cystic Fibrosis
Information source: University of Southern California
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Pioglitazone (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Southern California Official(s) and/or principal investigator(s):
Paul M Beringer, Pharm.D., Principal Investigator, Affiliation: University of Southern California
Overall contact:
Paul M Beringer, Pharm.D., Phone: 323-442-1402, Email: beringer@usc.edu
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.
Clinical Details
Official title: Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis
Study design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.
Secondary outcome: To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.
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. aeruginosa infection (e. g. aerosolized tobramycin, azithromycin)
provide short-term improvement in pulmonary function; however, persistence of the
infection/inflammation causes the inevitable loss of lung function. PPARgamma is a nuclear
transcription factor which is known to reduce activation of NFKB, a central mediator of
airway inflammation in CF. Recent studies demonstrate that PPARgamma expression is reduced
in patients with CF and may offer a potential therapeutic target to combat airway
inflammation in CF. Pioglitazone is a thiazolidinedione whose principal pharmacological
target it PPARgamma. The purpose of this pilot study is to determine the
pharmacokinetics/pharmacodynamics of pioglitazone and effect on reducing airway inflammation
in cystic fibrosis.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Paul M Beringer, Pharm.D., Phone: 323-442-1402, Email: beringer@usc.edu
University of Southern California, Los Angeles, California 90089, United States; Recruiting
Adupa Rao, M.D., Phone: 323-442-8522, Email: aprao@usc.edu
Debbie Benitez, R.N., Phone: 323-442-8522, Email: DEBBIEBenitez@tenethealth.org
Additional Information
Starting date: January 2008
Ending date: June 2009
Last updated: July 17, 2008
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