Status:
COMPLETED
Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 a...
Eligibility Criteria
Inclusion
- Male or female \>= 28 years of age
- Confirmed diagnosis of cystic fibrosis
- Forced Expiratory Volume in 1 second (FEV1) \>= 40% predicted
- Clinically stable
- Ability to reproduce spirometry
- Ability to understand and sign the informed consent
Exclusion
- Use of an investigational agent within 4-week period prior to Visit 1
- Chronic daily use of ibuprofen or other NSAIDS
- Chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents
- History of hypersensitivity to beta agonists
- History of hypersensitivity to glitazones
- Oxygen saturation\<92%
- Pregnant, breastfeeding or unwilling to practice acceptable birth control
- History of hemoptysis \>30cc per episode within 30 days prior to Visit 1
- Significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease
- Serum Glutamic-Oxaloacetic Transaminase (SGOT)/(Serum Glutamic Pyruvic Transaminase (SGPT) \>3 times the upper limit of normal at screening, documented biliary cirrhosis,or portal hypertension
- Creatinine \> 1.8 mg/dL at screening
- Inability to swallow pills
- Presence or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data
- Subjects who have routinely taken ibuprofen or other NSAIDS; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00322868
Start Date
April 1 2006
End Date
April 1 2007
Last Update
February 23 2018
Active Locations (1)
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1
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106