NCT00004440

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Interventions

Type	Name	Description
DRUG	ibuprofen

Timeline

• Start date: 1996-08-01
• Completion: 1999-06-01
• First posted: 1999-10-19
• Last updated: 2015-03-25