Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705793
• Other study ID #: 201801067
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinosinusitis
• Chronic Eosinophilic Rhinosinusitis
• Chronic Rhinosinusitis (Diagnosis)
• Rhinitis, Allergic
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Mösges R, Bachert C, Rudack C, Hauswald B, Klimek L, Spaeth J, Rasp G, Vent J, Hörmann 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Score <3 on the Clinical Global Impression Scale	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
Secondary	Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System	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