Kodgule Rahul, Magar Pankaj, Shivnitwar Sachin K, Wu Wen, Pendse Amol, Creado Sheldon, Patil Saiprasad, Barkate Hanmant, Tandon Monika
Research and Development, Glenmark Pharmaceuticals Limited, Mumbai, IND.
Pulmonology, Pulse Multispecialty Hospital, Pune, IND.
Cureus. 2024 Dec 16;16(12):e75836. doi: 10.7759/cureus.75836. eCollection 2024 Dec.
Background Cough in common cold is often associated with rhinorrhoea and nasal congestion, requiring treatment with a cough suppressant, decongestant, and antihistamine. Bilastine is a non-sedating antihistamine, a preferred option over sedating antihistamines. A combination of bilastine, dextromethorphan, and phenylephrine is expected to provide non-sedating treatment for cough associated with a common cold or allergy. Methods In this open-label, randomized, active-controlled, multicentre, clinical trial, adult and adolescent subjects with acute dry cough received bilastine 6.6 mg/dextromethorphan 20 mg/phenylephrine 10 mg syrup (BDP) thrice daily or Alex syrup (chlorpheniramine maleate 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) for seven days. The objective of the study was to evaluate the efficacy and safety of a fixed-dose combination syrup of bilastine, dextromethorphan, and phenylephrine in cough relief in patients with cough associated with a common cold or allergy. Results Of 134 randomized subjects, 67 received BDP and the remaining 67 received Alex® syrup. The least-square mean (LSM) standard error (SE) change in cough severity from baseline on day 4 was 37.86 mm (2.012) in the BDP group (p < 0.001), with a mean difference between the two groups of -4.09 mm (95% CI: -9.68, 1.51). The confidence interval was within the non-inferiority (NI) limits of 30 mm, proving non-inferiority to Alex syrup (p-value for NI < 0.001). The drowsiness score was significantly lower in the BDP group on day 2 (difference -0.46, p = 0.004), day 4 (difference -0.99, p < 0.001), and day 8 (difference -0.97, p < 0.001). No serious or severe adverse event was reported, and adverse events were comparable between the two groups. Conclusion Bilastine/dextromethorphan/phenylephrine combination syrup is efficacious, safe, non-sedating, and non-inferior to Alex syrup in the treatment of acute dry cough due to a common cold or allergy.
普通感冒引起的咳嗽常伴有流涕和鼻塞，需要使用止咳药、减充血剂和抗组胺药进行治疗。比拉斯汀是一种非镇静性抗组胺药，比镇静性抗组胺药更受青睐。比拉斯汀、右美沙芬和去氧肾上腺素的组合有望为普通感冒或过敏相关咳嗽提供非镇静性治疗。方法：在这项开放标签、随机、活性对照、多中心临床试验中，患有急性干咳的成人和青少年受试者接受比拉斯汀6.6毫克/右美沙芬20毫克/去氧肾上腺素10毫克糖浆（BDP），每日三次，或服用亚历克斯糖浆（马来酸氯苯那敏4毫克/右美沙芬20毫克/去氧肾上腺素10毫克），持续七天。该研究的目的是评估比拉斯汀、右美沙芬和去氧肾上腺素固定剂量组合糖浆对普通感冒或过敏相关咳嗽患者缓解咳嗽的疗效和安全性。结果：在134名随机分组的受试者中，67人接受BDP，其余67人接受亚历克斯®糖浆。BDP组第4天咳嗽严重程度相对于基线的最小二乘均值（LSM）标准误差（SE）变化为37.86毫米（2.012）（p < 0.001），两组之间的平均差异为-4.09毫米（95%置信区间：-9.68，1.51）。置信区间在30毫米的非劣效性（NI）范围内，证明不劣于亚历克斯糖浆（NI的p值< 0.001）。在第2天（差异-0.46，p = 0.004）、第4天（差异-0.99，p < 0.001）和第8天（差异-0.97，p < 0.001），BDP组的嗜睡评分显著更低。未报告严重或重度不良事件，两组之间的不良事件具有可比性。结论：比拉斯汀/右美沙芬/去氧肾上腺素组合糖浆在治疗普通感冒或过敏引起的急性干咳方面有效、安全、无镇静作用，且不劣于亚历克斯糖浆。
