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

- 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

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