Safety and Efficacy of Pioglitazone as an Anti-Inflammatory for the Treatment of CF Lung Disease
Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: pioglitazone (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Hospitals of Cleveland Official(s) and/or principal investigator(s):
Michael W. Konstan, MD, Principal Investigator, Affiliation: Case University and Rainbow Babies and Children's Hospital
Summary
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States
Additional Information
Starting date: April 2006
Ending date: April 2007
Last updated: September 20, 2007
|
