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Safety and Efficacy of Pioglitazone as an Anti-Inflammatory for the Treatment of CF Lung Disease

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00322868
First received: May 4, 2006
Last updated: September 20, 2007
Last verified: September 2007
History of Changes
  Purpose

Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.

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.


Condition Intervention
Cystic Fibrosis
 Drug: pioglitazone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Changes in markers of inflammation in induced sputum specimens obtained at Baseline and End of Treatment.
  • Total white cell count, total neutrophil count, and percent neutrophils
  • Active elastase
  • Cytokines: IL8,IL6, TNF, IL-1B
  • Safety Endpoints:
  • Change in bacterial count in induced sputum specimen.
  • Alterations in laboratory evaluations consisting of CBC, serum chemistry profile, CRP, ESR, U/A, and spirometry.
  • Adverse events associated with sputum induction or administration of study drug.

Estimated Enrollment: 20
Study Start Date: April 2006
Study Completion Date: April 2007
Detailed Description:

Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female >= 28 years of age
  • Confirmed diagnosis of cystic fibrosis
  • 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
  • SGOT/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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322868

Locations
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Michael W. Konstan, MD Case University and Rainbow Babies and Children's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00322868     History of Changes
Other Study ID Numbers: CFFTI-Pio001
Study First Received: May 4, 2006
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Prescription drugs
Administration, oral
Durable medical equipment
Kinetics

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Pathologic Processes
Anti-Inflammatory Agents
Pioglitazone
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013