CLINICAL STUDY ON THE APPLICATION OF VINSALPIUM IN THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): SHORT-TERM EVALUATION AND COMPARISON WITH A BRAND NAME DRUG WITH THE SAME SUBSTANCE

Abstract

Background and objectives: Vinsalpium is a combined short-acting bronchodilator (beta₂ adrenergic agonist and anticholinergic), produced domestically with international standard processes in the form of an aerosol solution and has been licensed for circulation in Vietnam (register number: VD-33654-19). This study aimed to evaluate short-term efficacy of the drug in patients with COPD (exacerbation and non-exacerbation) in terms of clinical effectiveness, functionality and side effects compared with brand name drug with the same active element (Combivent, Boehringer Ingelheim. Subjects and methods: Study patients were recruited from 5 treatment facilities with respiratory specialist activities distributed nationwide. The cases included in the study were diagnosed of COPD. Patients were randomly divided into 2 groups, each of which received an aerosol dose of the study drug (Vinsalpium) or the control drug (Combivent). Assessment of clinical symptoms and pulmonary function before and after drug administration was compared between the two groups. Results and discussion: There were 260 patients in the study, 130 patients in each group. The percentage of patients under management with spirometry were 74.2% and without it were 3.8%. The number of patients with frequent exacerbations were 119 (45.8%), the number of patients with at least one admitted severe exacerbation were 104 (40.00%). The number of patients attending by appointment were 163 (67.20%). The number of patients who received medication (including at least one of the short-acting bronchodilators, long-acting bronchodilators, and corticosteroids) prior to examination were 213 (82.00%). The average VAS score before the drug administration was 4.50. The number of patients with old tuberculosis leisons on chest Xray were 33 (12.70%). There were no differences in patient characteristics in the study between the two groups (except that the number of patients with combined old TB lesions were greater in the group using the study drug (p=0.005) than the other). The efficacy and safety of the investigational drug (Vinsalpium) compared to the control drug (Combivent) was equivalent. There were small differences in blood pressure stability pre and post-medication, post-medication VAS score, and VAS score via telephone interview favoring the study drug (p values: 0.03; 0.028; and 0.013, respectively). Conclusions: In 260 study patients, most of them had been diagnosed COPD, were being managed and treated. The study showed that there were patient characteristics that need to be noted in terms of indications for drug, treatment efficacy and BMI value. There were no differences in patient characteristics in study between the two groups (except that the number of patients with combined old tuberculosis lesions was greater in the group using the study drug than the other). Efficacy and safety of the study drug (Vinsalpium ) compared to the control drug (Combivent ) are equivalent. There were small differences in blood pressure stability pre and post-medication, post-medication VAS score, and VAS score via telephone interview favoring Vinsalpium.