NCT04915456

Effect of Postoperative Additive Systemic Steroids in CRSwNP

Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 mucus/serum biomarkers will be measured.

Conditions

• Sinusitis, Chronic

Interventions

Type	Name	Description
DRUG	Systemic Steroid (Prednisolone)	Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS
OTHER	Placebo	Placebo additive to topical steroids in a postoperative setting after FESS

Timeline

• Start date: 2005-01-18
• Primary completion: 2020-04-01
• Completion: 2021-02-01
• First posted: 2021-06-07
• Last updated: 2021-06-07