Effect of Postoperative Additive Systemic Steroids in CRSwNP

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Treatments: Prednisolone

Criteria

Inclusion Criteria:

• CRSwNP

• refractory to medical therapy

• no previous sinus surgery

• Lund-Kennedy-Score ≥ 1

• Lund-Mackay-Score ≥ 10

Exclusion Criteria:

• ciliary impairment

• autoimmune disease

• cystic fibrosis

• immunodeficiency