Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00004440|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: ibuprofen||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||75 participants|
|Masking:||None (Open Label)|
|Study Start Date :||August 1996|
|Study Completion Date :||June 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004440
|Study Chair:||Michael W Konstan||Case Western Reserve University|