A clinical study on the combination of bencycloquidium bromide and montelukast in the treatment of moderate to severe allergic rhinitis.

BACKGROUND

Bencycloquidium bromide (BCQB) is a novel synthesized quaternary ammonium salt compound based on the classic anticholinergic drug ipratropium bromide. This study was to compare the efficacy of BCQB and montelukast (MNT) combination therapy to that of MNT monotherapy in the treatment of moderate to severe allergic rhinitis ((M/S)AR).

METHODS

This study enrolled enrolled 300 patients with (M/S)AR. The participants were randomized to receive BCQB (180 μg each time, qid) plus MNT (10 mg qn) (BCQB + MNT group) or MNT alone (10 mg qn) for 4 weeks. The visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching, and the rhinoconjunctivitis quality of life questionnaire (RQLQ) were assessed before and at the end of treatments. Adverse events were recorded in detail.

RESULTS

FAS analysis was performed on a total of 133 and 134 patients, in the BCQB + MNT group and in MNT group, respectively. The baseline information was comparable. Both treatments significantly reduced the score of total VAS and 4 main VAS symptoms compared to baseline. However, the BCQB + MNT group exhibited significantly greater decrease in scores for rhinorrhea and nasal congestion compared to MNT alone. After 2 weeks of treatment, the BCQB + MNT group showed significantly larger decrease in the RQLQ score in terms of daily living, nonnasal and ocular symptoms, behavioral problems, nasal symptoms, and ocular symptoms compared to MNT alone. At the end of the trial, both treatments significantly reduced the total RQLQ score from baseline; however, the BCQB + MNT group showed significant decrease in scores compared to MNT alone. Mild and transient adverse events were recorded, which were similar between the 2 groups.

CONCLUSION

The combination of BCQB and MNT had a greater overall effect, compared to MNT monotherapy in improving nasal symptoms such as nasal congestion and rhinorrhea, as well as quality of life in the treatment of (M/S)AR.