NCT03705793

Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.

Detailed description

Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The overall goal of this proposed research project is to optimize topical delivery of MF to the paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure nasal saline irrigation. The investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the effectiveness of MF nasal irrigation compared to MF nasal spray.

Conditions

• Chronic Rhinosinusitis (Diagnosis)
• Allergic Rhinosinusitis
• Chronic Eosinophilic Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Mometasone Furoate Nasal Irrigation	Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.
DRUG	Mometasone Nasal Spray	Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-02-15
• Completion: 2020-03-15
• First posted: 2018-10-15
• Last updated: 2025-06-26
• Results posted: 2020-12-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study