Hydroxychloroquine in Cystic Fibrosis
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis|
- Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis. Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Bonnie S Slovis, MD||Vanderbilt University|