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Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

NCT03705793 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-06-26

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jay F Piccirillo, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-02-15
Completion
2020-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705793 on ClinicalTrials.gov