Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311883
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2006-04-04
Brief Title:
Hydroxychloroquine in Cystic Fibrosis
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None