Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
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|ClinicalTrials.gov Identifier: NCT00322868|
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Drug: pioglitazone|
- 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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This was open-label and no one was masked.|
|Official Title:||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|
|Study Start Date :||April 2006|
|Primary Completion Date :||December 2006|
|Study Completion Date :||April 2007|
U.S. FDA Resources
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
- Sputum White Cell Count [ Time Frame: Day 0 and Day 29 ]The total number of white cells log 10 cells/mL
- Sputum Neutrophil Count [ Time Frame: Day 0 and Day 29 ]sputum neutrophils log 10 (cells/mL)
- Sputum Neutrophil Percent [ Time Frame: Day 0 and Day 29 ]Neutrophils as a percent of the total white cells.
- Sputum Active Elastase [ Time Frame: Day 0 and Day 29 ]Log 10 of Concentration of active Elastase in mcg/mL
- Sputum TNFα [ Time Frame: Day 0 and Day 29 ]The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
- Sputum IL-1ß [ Time Frame: Day 0 and Day 29 ]The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
- Sputum IL-6 [ Time Frame: Day 0 and Day 29 ]The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
- Sputum IL-8 [ Time Frame: Day 0 and Day 29 ]Concentration of Interleukin-8 log 10 (pg/mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322868
|United States, Ohio|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Michael W. Konstan, MD||Case University and Rainbow Babies and Children's Hospital|