Effect of Pioglitazone on Inflammation in Cystic Fibrosis
Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis
2 other identifiers
interventional
24
1 country
1
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 body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 14, 2012
June 1, 2012
1.4 years
July 17, 2008
June 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.
83 days
Secondary Outcomes (1)
To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.
83 days
Study Arms (2)
1
ACTIVE COMPARATORTreatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)
2
NO INTERVENTIONPatients in this arm will receive no intervention
Interventions
Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- Clinically stable (FEV1 within 10% of baseline)
- FEV1 \> 40% predicted
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul Beringerlead
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul M Beringer, Pharm.D.
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 14, 2012
Record last verified: 2012-06