Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2006-12
- Completion
- 2007-04
Outcome
Mixed primary results
registry MEAN Baseline: 82.47 (Standard Deviation 11.88) Percent (%) of white blood cells MEAN Post-Treatment: 74.44 (Standard Deviation 17.07) Percent (%) of white blood cells NCT00322868 ↗
registry analysis (superiority or other test); Baseline vs Post-Treatment; p = 0.0288; t-test, 1 sided NCT00322868 ↗
registry analysis (superiority or other test); Baseline vs Post-Treatment; p = 0.2772; t-test, 1 sided NCT00322868 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pioglitazone | Small molecule | 30 mg | Oral |