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Effect of Pioglitazone on Inflammation in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00719381
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
Paul Beringer, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Pioglitazone Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis
Study Start Date : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling. [ Time Frame: 83 days ]

Secondary Outcome Measures :
  1. To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis. [ Time Frame: 83 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719381

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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Paul Beringer
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Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
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Responsible Party: Paul Beringer, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00719381    
Other Study ID Numbers: HS-07-00308
IND #: 101989
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hypoglycemic Agents
Physiological Effects of Drugs