A randomized comparison of bencycloquidium bromide, mometasone furoate and a combination for persistent allergic rhinitis

J Allergy Clin Immunol Pract. 2024 Dec 31:S2213-2198(24)01284-4. doi: 10.1016/j.jaip.2024.12.035. Online ahead of print.

Abstract

Background: Moderate to severe persistent allergic rhinitis (AR) poses a substantial socioeconomic burden.

Objectives: We aimed to establish the superiority of bencycloquidium bromide (BCQB) nasal spray and BCQB combined with mometasone furoate nasal spray (MFNS) over MFNS alone in adults with moderate-to-severe persistent AR.

Methods: In this multicentre, randomised controlled clinical trial (NCT05038202), adults with moderate-to-severe persistent AR were randomly assigned to receive the BCQB, MFNS, or a combination treatment, for 4-week periods. The mean changes from baseline in the daily reflective runny nose, nasal congestion, sneezing, nasal itching scores, total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores were recorded. The exploratory endpoints and adverse events were also assessed.

Results: BCQB led to a significant improvement in the mean change from baseline in daily reflective runny nose during the 4-week treatment, in comparison to MFNS (least-squares [LS] mean difference, -0.27; 95% confidence interval [CI], -0.44 to -0.09; P=.004). BCQB combined with MFNS significantly improved runny nose, nasal congestion, sneezing, TNSS, and RQLQ scores compared to MFNS alone, except for nasal itching. BCQB significantly decreased the percentage change in eosinophilic cationic protein, eotaxin, vasoactive intestinal peptide, and interleukin-6 levels. Treatment-emergent adverse events were similar among the three groups.

Conclusion: BCQB was superior to the MFNS in reducing daily runny nose symptoms. The combination of BCQB and MFNS was superior to MFNS alone in alleviating TNSS in patients with moderate-to-severe persistent AR with a predominant symptom of runny nose.

Keywords: allergic rhinitis; cholinergic antagonists; clinical trial; moderate-to-severe.