Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis

NCT ID: NCT00004440


Title
Purpose
OBJECTIVES: I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls. II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.
Details
PROTOCOL OUTLINE: This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period. The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).
Conditions
Cystic Fibrosis
Keywords
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Source
FDA Office of Orphan Products Development
Sponsors
FDA Office of Orphan Products Development, Case Western Reserve University
Status
Completed
Acronym
Last Updated
23 Mar 2015
URL
Official Link
Locations