Effect of Pioglitazone on Inflammation in Cystic Fibrosis

June 13, 2012 updated by: Paul Beringer

Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Actos
No Intervention: 2
Patients in this arm will receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.
Time Frame: 83 days
83 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.
Time Frame: 83 days
83 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Beringer

Investigators

  • Principal Investigator: Paul M Beringer, Pharm.D., University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 17, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-07-00308
  • IND #: 101989

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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