drugset
drugset / Trial / NCT04163978

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

NCT04163978 ↗

Phase 2 Completed 56 enrolled Sanotize Research and Development corp.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This a single center, randomized controlled trial to evaluate safety \& efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). It is hypothesized that a daily treatment of NOSi over a 6-week period will be safe and effective at reducing clinical symptoms associated with RCRS.

Timeline

Start
2019-10-27
Primary completion
2022-05-03
Completion
2022-05-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 1 mg Other
Subject Nitric Oxide Other / unclassified 240 ml Other

Indications

chronic rhinosinusitis