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Effect of Pioglitazone on Inflammation in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pioglitazone

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)

Patients in this arm will receive no intervention

Outcomes

Primary Outcome Measures

To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.

Secondary Outcome Measures

To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.

Full Information

NCT ID

NCT00719381

First Posted

July 17, 2008

Last Updated

June 13, 2012

Sponsor

Paul Beringer

1. Study Identification

Unique Protocol Identification Number

NCT00719381

Brief Title

Effect of Pioglitazone on Inflammation in Cystic Fibrosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul Beringer

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)

Arm Title

Arm Type

No Intervention

Arm Description

Patients in this arm will receive no intervention

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Other Intervention Name(s)

Actos

Intervention Description

Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)

Primary Outcome Measure Information:

Title

To determine the effect of pioglitazone on sputum biomarkers of lung inflammation and remodeling.

Time Frame

83 days

Secondary Outcome Measure Information:

Title

To characterize the pharmacokinetics, pharmacodynamics and safety of pioglitazone in patients with cystic fibrosis.

Time Frame

83 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul M Beringer, Pharm.D.

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90089

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Pioglitazone on Inflammation in Cystic Fibrosis

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