NCT00322868

Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease

A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease. Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.

Detailed description

* Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease * Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment) * Changes in markers of inflammation in the sputum samples will be assessed * Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	pioglitazone	All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-12-01
• Completion: 2007-04-01
• First posted: 2006-05-08
• Last updated: 2018-02-23
• Results posted: 2018-02-23

Locations

1 site across 1 country: United States