Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04915456
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2021-05-24
Brief Title:
Effect of Postoperative Additive Systemic Steroids in CRSwNP
Sponsor:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Organization:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study Overview
Official Title:
Prospective Randomized Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps
Status:
COMPLETED
Status Verified Date:
2021-06
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:
This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis CRSwNP All patients receive a functional endoscopic sinus surgery FESS followed by topical steroid spray for 3 months Postoperatively patients will be randomized to either an additional systemic steroid or a placebo for 1 month Patients will be followed for 2 years Effect on Nasal Polyp score NPS Lund-Kennedy-Score LKS recurrence rates smell scores Rhinosinusitis Disability Index RSDI Short-Form 36 SF-36 and mucusserum biomarkers will be measured
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None