Effect of Pioglitazone on Inflammation in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Beringer, University of Southern California
ClinicalTrials.gov Identifier:
NCT00719381
First received: July 17, 2008
Last updated: June 13, 2012
Last verified: June 2012
  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 1

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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling. [ Time Frame: 83 days ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 24
Study Start Date: January 2008
Study Completion Date: June 2009
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719381

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Paul Beringer
Investigators
Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
  More Information

No publications provided

Responsible Party: Paul Beringer, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00719381     History of Changes
Other Study ID Numbers: HS-07-00308, IND #: 101989
Study First Received: July 17, 2008
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014