Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Anti-Inflammatory Agents; Pioglitazone

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