Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004440
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CWRU-FDR001185 | None | None | None |