Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Prescription drugs, Administration, oral, Durable medical equipment, Kinetics
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Rainbow Babies and Children's Hospital
Arms of the Study
Arm 1
Experimental
Pioglitazone
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda