drugset / Trial / NCT02748070

Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

NCT02748070 ↗

Completed 81 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.

Timeline

Start
2015-08
Primary completion
2019-07-15
Completion
2019-07-15

Outcome

Missed primary endpoint

paper there was no clinically meaningful difference observed in SNOT-22 total PMID 33662124 ↗

paper oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores PMID 33662124 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisone Other / unclassified — Oral
Background Fluticasone propionate Other / unclassified — Intranasal