Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

July 14, 2022 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

  • mucopurulent drainage(anterior, posterior, or both)
  • nasal obstruction (congestion)
  • facial pain-pressure-fullness
  • and decreased sense of smell

AND inflammation documented by one or more of the following findings:

  • purulent mucus or edema in the middle meatus or ethmoid region
  • radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria:

  • inability to speak or understand English
  • nasal polyps
  • history of nasal or sinus surgery
  • comorbid mucociliary conditions
  • dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
  • history of oral or systematic antibiotic use in the past 2 weeks
  • history of allergy to MF or other topical steroids
  • pregnant or breastfeeding
  • participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mometasone Furoate Nasal Irrigation
The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
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.
Active Comparator: Mometasone Nasal Spray
The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
Drug: Mometasone Nasal Spray
Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Other Names:
  • Nasonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time Frame: Change from Baseline to Week 8

The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.

All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks")
Change from Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Score <3 on the Clinical Global Impression Scale
Time Frame: Week 8
CGI asks subjects to rate their overall response to treatment using a 7-point Likert scale with anchors of 1=very much improved, 4=no change, and 7=very much worse.
Week 8
Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System
Time Frame: Change from Baseline to Week 8

A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system.

The The Lund Kennedy System grades the pathologic state of the nasal cavity based on the presence of polyps, nasal discharge, and mucosal edema.

Polyps graded from 0 to 2 (0=absent, 1=limited to middle meatus, 2=extending to nasal cavity) Discharge graded from 0 to 2 (0=absent, 1=thin/clear, 2=thick) Edema graded from 0 to 2 (0=absent, 1=mild/moderate, 2=polypoid degeneration). Scores are added for each side of the nose with a minimum score of 0 and maximum score of 12 with higher scores indicating more severe sinonasal inflammation.
Change from Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

February 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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