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

NCT ID: NCT00322868

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-04-30

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

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitazone

All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda

Group Type: EXPERIMENTAL

pioglitazone

Intervention Type: DRUG

All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Interventions

pioglitazone

All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Intervention Type: DRUG

Other Intervention Names

Actos; Takeda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael W. Konstan

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael W. Konstan, MD

Role: PRINCIPAL_INVESTIGATOR

Case University and Rainbow Babies and Children's Hospital

Locations

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CFFTI-Pio001

Identifier Type: -

Identifier Source: org_study_id