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

Sponsor:	University Hospitals of Cleveland
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00322868

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

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

Study ID Numbers:	CFFTI-Pio001
Study First Received:	May 4, 2006
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00322868 History of Changes
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:

Anti-Inflammatory Agents
Pioglitazone
Fibrosis
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Therapeutic Uses
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on February 08, 2010