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Effect of Pioglitazone on Inflammation in Cystic Fibrosis

Sponsor
Paul Beringer (Other)
Overall Status
Completed
CT.gov ID
NCT00719381
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
17
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling. [83 days]

    Secondary Outcome Measures

    1. To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis. [83 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 21, 2008
    Last Update Posted:
    Jun 14, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Inflammation
    Pioglitazone

    Study Results

    No Results Posted as of Jun 14, 2012