Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

NCT03705793 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201801067
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

mometasone irrigation chronic rhinosinusitis; mometasone spray; rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change in Sino-Nasal Outcome Test Scores (SNOT-22)

  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 Outcomes (2)

• Number of Participants Who Score <3 on the Clinical Global Impression Scale

  Week 8

• Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System

  Change from Baseline to Week 8

Study Arms (2)

Mometasone Furoate Nasal Irrigation

EXPERIMENTAL

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

Mometasone Nasal Spray

ACTIVE COMPARATOR

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

Interventions

Mometasone Furoate Nasal Irrigation DRUG

Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.

Mometasone Furoate Nasal Irrigation

Mometasone Nasal Spray DRUG

Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.

Also known as: Nasonex

Mometasone Nasal Spray

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

• Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Bachert C, Baraniuk J, Baroody FM, Benninger MS, Brook I, Chowdhury BA, Druce HM, Durham S, Ferguson B, Gwaltney JM Jr, Kaliner M, Kennedy DW, Lund V, Naclerio R, Pawankar R, Piccirillo JF, Rohane P, Simon R, Slavin RG, Togias A, Wald ER, Zinreich SJ; American Academy of Allergy, Asthma and Immunology; American Academy of Otolaryngic Allergy; American Academy of Otolaryngology-Head and Neck Surgery; American College of Allergy, Asthma and Immunology; American Rhinologic Society. Rhinosinusitis: Establishing definitions for clinical research and patient care. Otolaryngol Head Neck Surg. 2004 Dec;131(6 Suppl):S1-62. doi: 10.1016/j.otohns.2004.09.067.

  PMID: 15577816 BACKGROUND

• Ray NF, Baraniuk JN, Thamer M, Rinehart CS, Gergen PJ, Kaliner M, Josephs S, Pung YH. Healthcare expenditures for sinusitis in 1996: contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):408-14. doi: 10.1016/s0091-6749(99)70464-1.

  PMID: 10069873 BACKGROUND

• Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.

  PMID: 21493210 BACKGROUND

• Kalish LH, Arendts G, Sacks R, Craig JC. Topical steroids in chronic rhinosinusitis without polyps: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2009 Dec;141(6):674-83. doi: 10.1016/j.otohns.2009.08.006.

  PMID: 19932837 BACKGROUND

• Rudmik L, Hoy M, Schlosser RJ, Harvey RJ, Welch KC, Lund V, Smith TL. Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Apr;3(4):281-98. doi: 10.1002/alr.21096. Epub 2012 Oct 8.

  PMID: 23044832 BACKGROUND

• Thomas WW 3rd, Harvey RJ, Rudmik L, Hwang PH, Schlosser RJ. Distribution of topical agents to the paranasal sinuses: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Sep;3(9):691-703. doi: 10.1002/alr.21172. Epub 2013 May 31.

  PMID: 23729216 BACKGROUND

• Harvey RJ, Schlosser RJ. Local drug delivery. Otolaryngol Clin North Am. 2009 Oct;42(5):829-45, ix. doi: 10.1016/j.otc.2009.07.005.

  PMID: 19909862 BACKGROUND

• Snidvongs K, Pratt E, Chin D, Sacks R, Earls P, Harvey RJ. Corticosteroid nasal irrigations after endoscopic sinus surgery in the management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2012 Sep-Oct;2(5):415-21. doi: 10.1002/alr.21047. Epub 2012 May 7.

  PMID: 22566474 BACKGROUND

• Bachert C, Meltzer EO. Effect of mometasone furoate nasal spray on quality of life of patients with acute rhinosinusitis. Rhinology. 2007 Sep;45(3):190-6.

  PMID: 17956016 BACKGROUND

• Mosges R, Bachert C, Rudack C, Hauswald B, Klimek L, Spaeth J, Rasp G, Vent J, Hormann K. Efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis. Adv Ther. 2011 Mar;28(3):238-49. doi: 10.1007/s12325-010-0105-7. Epub 2011 Feb 3.

  PMID: 21318604 BACKGROUND

• Derendorf H, Meltzer EO. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008 Oct;63(10):1292-300. doi: 10.1111/j.1398-9995.2008.01750.x.

  PMID: 18782107 BACKGROUND

MeSH Terms

Conditions

Disease; Rhinitis, Allergic, Perennial; Rhinosinusitis

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pawina JIramongkolchai, MD
• Organization: Washington University in St. Louis

pawina@wustl.edu

314-362-5296

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: January 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: March 15, 2020
• Last Updated: June 26, 2025
• Results First Posted: December 19, 2020

Record last verified: 2025-06

Locations

US (2)