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| Sponsor: | University of Southern California |
|---|---|
| Information provided by: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT00719381 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Pioglitazone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis |
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)
|
Drug: Pioglitazone
Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)
Other Name: Actos
|
|
No Intervention: 2
Patients in this arm will receive no intervention
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paul M Beringer, Pharm.D. | 323-442-1402 | beringer@usc.edu |
| Contact: Adupa Rao, M.D. | 323-442-8522 | aprao@usc.edu |
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90089 | |
| Contact: Adupa Rao, M.D. 323-442-8522 aprao@usc.edu | |
| Contact: Debbie Benitez, R.N. 323-442-8522 DEBBIEBenitez@tenethealth.org | |
| Principal Investigator: | Paul M Beringer, Pharm.D. | University of Southern California |
More Information
| Responsible Party: | Paul Beringer, Pharm.D., University of Southern California School of Pharmacy |
| ClinicalTrials.gov Identifier: | NCT00719381 History of Changes |
| Other Study ID Numbers: | HS-07-00308, IND #: 101989 |
| Study First Received: | July 17, 2008 |
| Last Updated: | July 17, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Cystic Fibrosis Fibrosis Inflammation Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
