Cystic Fibrosis Clinical Trial
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
Verified date | February 2018 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | April 2007 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rainbow Babies and Children's Hospital | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sputum White Cell Count | The total number of white cells log 10 cells/mL | Day 0 and Day 29 | |
Primary | Sputum Neutrophil Count | sputum neutrophils log 10 (cells/mL) | Day 0 and Day 29 | |
Primary | Sputum Neutrophil Percent | Neutrophils as a percent of the total white cells. | Day 0 and Day 29 | |
Primary | Sputum Active Elastase | Log 10 of Concentration of active Elastase in mcg/mL | Day 0 and Day 29 | |
Primary | Sputum TNFa | The concentration of Tumor Necrosis Factor-a (TNFa) log 10 (pg/mL) | Day 0 and Day 29 | |
Primary | Sputum IL-1ß | The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL) | Day 0 and Day 29 | |
Primary | Sputum IL-6 | The concentration of Interleukin-6 (IL-6) log 10 (pg/mL) | Day 0 and Day 29 | |
Primary | Sputum IL-8 | Concentration of Interleukin-8 log 10 (pg/mL) | Day 0 and Day 29 |
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