A multicenter study to evaluate the efficacy and safety of compound methoxyphenamine in the treatment of postinfectious cough
ZHOU Xin, BAO Wu-ping, QU Jie-ming, ZHU Hui-li, DENG Wei-wu, WAN Huan-ying, GUO Xue-jun, QIU Zhong-min, REN Zhen-yi
Published 2011-12-05
Cite as Int J Respir, 2011,31(23): 1761-1765. DOI: 10.3760/cma.j.issn.1673-436x.2011.023.001
Abstract
Objective To evaluate the efficacy and safety of compound methoxyphenamine in the treatment of postinfectious cough.Methods An open,perspective,multicenter clinical trial was conducted.Subjects who meet with the diagnostic of postinfectious cough and with cough symptom score greater than 2 were recruited by six different teaching hospitals at the department of respiration.The test drug compound methoxyphenamine capsule was produced by Japan's Daiichi Sankyo Pharmaceutical Co.Ltd.Japan (brand name:Asmeton Strong capsule).Two capsules of test drug were orally administrated to subjects after meal 3 times per day for a 7-10 days treatment.The primarily endpoint was the evaluation of cough severity.Results There were 441 subjects randomized to study treatment (FAS),with 162 male and 279 female.The average age for FAS is 45.6,with a age range of 18～70.Cough duration of patients enrolled in the study rangs from 1 to 60 days and average cough duration is 29.8days.Of the 394 patients metting Per protocol set (PP),symptoms were relief (56.090％,221 patients),significantly improved (34.01 ％,134 patients),slightly better (5.08％,20 patients),and not improved (4.82 ％,19 patients).The average cough score of daytime and nocturnality,total cough score,and cough severity score were statistically significantly lower ( P ＜ 0.000 1 ).The total cough score and cough severity score were significantly decreased after 48 hrs treatment ( P ＜ 0.000 1 ).442 patients were totally used for safety analysis,in which 88 patients (20.85％) had minor or milder side-effects and 79 patients (18.72％) were confirmed their side-effects were related to methoxyphenamine treatment.Serious side-effects were not observed during whole study.Conclusions Compound methoxyphenamine resulted in clinically important and statistically significant impróve symptoms of patients with postinfectious cough.In addition,compound methoxyphenamine is associated with minor or milder sideeffects.These results suggested that compound methoxyphenamine as a safe and efficient drug can be widely used in postinfectious cough treatment.
Key words:
Postinfectious cough; Treatment; Compound methoxyphenamine
Contributor Information
ZHOU Xin
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
BAO Wu-ping
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
QU Jie-ming
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
ZHU Hui-li
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
DENG Wei-wu
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
WAN Huan-ying
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
GUO Xue-jun
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
QIU Zhong-min
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
REN Zhen-yi
Department of Respirtory Medicine,Shanghai First People's Hospital ,Shanghai J iaotong University ,Shanghai 200080 ,China
