Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416182
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2006-12-26
Brief Title:
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Chronic sinusitis is a frequent complication in cystic fibrosis The aim of this study is to determine whether Pulmozymedornase alfa would maintain sinus health compared to placebo in patients with cystic fibrosis who have recently undergone sinus surgery
Detailed Description:
AIM To evaluate the effectiveness of Pulmozymedornase alfa in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis CF
PROCEDURES 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months Consent will be obtained following surgery and treatment will begin 1 week post-operatively
Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 25 6 9 and 12 months
Outcome measures will include ciliary function testing pulmonary function testing sinus questionnaires and CT scan
PROCEDURES 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months Consent will be obtained following surgery and treatment will begin 1 week post-operatively
Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 25 6 9 and 12 months
Outcome measures will include ciliary function testing pulmonary function testing sinus questionnaires and CT scan
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