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

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00322868

Run by

University Hospitals Cleveland Medical Center

People needed

21

Starts

2006-04-01

Expected to finish

2007-04-01

Last updated by the study team

2018-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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