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

University Hospitals (UH)

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Drug: pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00322868

CFFTI-Pio001

Details and patient eligibility

About

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.

Full 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 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

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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