Efficacy and safety of intranasal bencycloquidium bromide in nasal symptoms of common cold: a phase 3, multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND

Common cold is one of the most prevalent illnesses affecting human health. Nasal symptoms are the most bothersome and characteristic manifestations, yet few safe and effective treatments are currently available.

AIM: This phase 3, randomized, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of bencycloquidium bromide (BCQB) nasal spray in nasal symptoms of common cold.

METHODS

Participants with cold symptoms for ≤48 h and a rhinorrhea visual analogue scale (VAS) score ≥5 were enrolled. Participants were randomized 1:1 to receive either BCQB or placebo for 4 ± 1 days. Patients self-recorded VAS scores for rhinorrhea, sneezing, nasal congestion and itching daily. Efficacy and safety were assessed.

RESULTS

A total of 480 patients were randomized and treated. The area under the curve (AUC) for rhinorrhea VAS scores over treatment period was significantly lower in the BCQB group than in the placebo group (13.01 ± 7.19 vs. 16.01 ± 8.00; P < 0.001). Daily improvement in the average rhinorrhea VAS score was significantly greater in the BCQB group from day 2 through day 4 (P < 0.005). BCQB also demonstrated significant efficacy for nasal congestion (AUC: 10.90 ± 7.42 vs. 13.63 ± 8.64; P < 0.001) and sneezing (AUC: 7.84 ± 7.18 vs. 9.30 ± 8.64; P = 0.046). The incidence of adverse events (AEs) was similar between the two groups, and no severe AEs were reported. BCQB was well-tolerated, with no systemic anticholinergic adverse effects observed.

CONCLUSIONS

BCQB nasal spray is effective and safe for treating rhinorrhea, nasal congestion and sneezing associated with common cold.

TRIAL REGISTRATION: The trial was registered at chictr.org.cn (ChiCTR2500107341).