Clinical trial NCT00322868: Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
Official title: A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Prescription drugs
Administration, oral
Durable medical equipment
Kinetics
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2006-05-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Sputum White Cell Count
timeFrame: Day 0 and Day 29
measure: Sputum Neutrophil Count
timeFrame: Day 0 and Day 29
measure: Sputum Neutrophil Percent
timeFrame: Day 0 and Day 29
measure: Sputum Active Elastase
timeFrame: Day 0 and Day 29
measure: Sputum TNFα
timeFrame: Day 0 and Day 29
measure: Sputum IL-1ß
timeFrame: Day 0 and Day 29
measure: Sputum IL-6
timeFrame: Day 0 and Day 29
measure: Sputum IL-8
timeFrame: Day 0 and Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Case University and Rainbow Babies and Children's Hospital
name: Michael W. Konstan, MD
role: PRINCIPAL_INVESTIGATOR
References: