Randomized clinical trial to evaluate mometasone lavage vs spray for patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery

Abstract

Background: There is no consensus regarding the best route of intranasal delivery of corticosteroids in the treatment of chronic rhinosinusitis (CRS). The study objective of this work was to compare the impact of mometasone furoate nasal spray (MFNS) vs mometasone nasal irrigation in the management of CRS patients who have not undergone sinus surgery.

Methods: A double-blind, placebo-controlled, randomized clinical trial was conducted in adults with CRS. Individuals with nasal polyps and/or history of sinus surgery were excluded. Patients were randomized to receive 8 weeks of either MFNS or mometasone nasal irrigation. The primary outcome measure was change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score between the 2 groups. Secondary outcome measures included patient global response to treatment and Lund-Kennedy endoscopy scores.

Results: A total of 43 participants completed the study (n = 22, MFNS; n = 21,mometasone nasal irrigation). Fourteen (64%) participants in the MFNS group and 17 (81%) in the mometasone lavage group had a clinically meaningful improvement in SNOT-22 scores with a proportion difference of 17% (95% confidence interval [CI], -9% to 44%). The least-squares (LS) mean difference between the 2 groups for SNOT-22 was -8.6 (95% CI, -17.7 to 0.58; p = 0.07), whereas the LS mean difference between the 2 groups for Lund-Kennedy endoscopy scores was 0.16 (95% CI, -0.84 to 1.15; p = 0.75). No adverse events were associated with the study.

Conclusion: Both MFNS and mometasone nasal irrigations are beneficial in symptom management of CRS. Our study suggests that patients who perform mometasone lavage do better in a clinically meaningful way, but our results are not definitive and further studies are warranted.

Keywords: chronic rhinosinusitis; nasal lavage; topical intranasal corticosteroid.

Conflict of interest statement

Financial Disclosures: JS is a consultant for Medtronic, Olympus, and Optinose. He is also on the speaker bureau for Optinose. CKC is a consultant for Medtronic. JFP receives royalty income for use of the SNOT-22 instrument. All other authors have no financial disclosures or conflicts of interest.

© 2020 ARS-AAOA, LLC.

Figures

Figure 1.

Flowchart of Patients Enrolled and Included in Analysis

Figure 2.

SNOT-22 Scores by Treatment Group Over Time. The dashed line represents the mometasone nasal irrigation group plus nasal saline spray while the solid line represents the saline nasal irrigation plus MFNS group. The error bars represent the minimum and maximum SNOT-22 values.

Figure 3.

Comparison of Change in SNOT-22 Scores Between the 2 Treatment Groups. *The box and whisker plots represent change in SNOT-22 within each treatment group. The solid dashed line within the box represents the median value, the upper and lower part of the box represents the 75th and 25th percentile, the “whiskers” represent the upper and lower extreme of values, and the open circle represents outliers. The dashed horizontal line represents the clinically meaningful important difference of SNOT-22 score by 9 points.