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.
* 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Sputum White Cell Count
The total number of white cells log 10 cells/mL
Time frame: Day 0 and Day 29
Sputum Neutrophil Count
sputum neutrophils log 10 (cells/mL)
Time frame: Day 0 and Day 29
Sputum Neutrophil Percent
Neutrophils as a percent of the total white cells.
Time frame: Day 0 and Day 29
Sputum Active Elastase
Log 10 of Concentration of active Elastase in mcg/mL
Time frame: Day 0 and Day 29
Sputum TNFα
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Time frame: Day 0 and Day 29
Sputum IL-1ß
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Time frame: Day 0 and Day 29
Sputum IL-6
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
Time frame: Day 0 and Day 29
Sputum IL-8
Concentration of Interleukin-8 log 10 (pg/mL)
Time frame: Day 0 and Day 29
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