GlaxoSmithKline and Innoviva announce positive results from Phase III clinical study of new lung disease drug Trelegy Ellipta for asthma treatment

recently, British drugcompany GlaxoSmithKline (GSK) and partner Innoviva jointly announced the positive results of the critical phase III clinical study CAPTAIN (NCT02924688) for the treatment of asthma in theof lung
disease (http://Trelegy Ellipta (fluoric brominamium/Villentero, FF/UMEC/VI) for the treatment of asthmaThe study was conducted in a randomized, double-blind, positivedrug(http://control, 6 parallel groups, and a global multicenter study, in asthma patients who were treated with ICS/LABA (?250mcg/paraceane fluorobutiasone or equivalent) and were under-controlled, assessed once a day ff/UMEC/VI (10) 0/31.25/25, 100/62.5/25, 200/31.25/25, 200/62.5/25 mcg) vsonce-daily FF/VI (100/25 and 200/25 mcg) for efficacy and safetythe study was conducted in 15 countries around the world and involved a total of 2,436 patients randomly assigned to six treatment groups, each with about 400 patientsThe main endpoint of the study was the change in the relative baseline of the first second of the first-second strong exhalation (FEV1) valley in week 24, and the key secondary endpoint was the annualized rate of moderate/severe asthma attacksThe results showed that the study reached the main end point: (1) compared to Relvar/Breo (FF/VI) 100/25mcg, FF/UMEC/VI 100/62.5/25 mcg significantly improved lung function (measured by the relative baseline change of fEV1 valley value in the 24th week of treatment), and the data were statistically significant (p.0.001, 9 5%CI: 66-153 ml) ;(2) compared to Relvar/Breo (FF/VI)200/25mcg, FF/UMEC/VI 200/62.5/25mcg significantly improved lung function by 92 ml and the data were statistically significant (p 0.001, 95%CI: 49-135 ml)In terms of critical secondary endpoints, THE ANNUALIZATION RATE OF MODERATE/SEVERE ASTHMA ATTACKS DECREASED BY 13% (95% CI: 5.2-28.1) COMPARED TO RELVAR/BREO (FF/VI, 100/25 AND 200/25), BUT NOT STATISTICALLY SIGNIFICANTTherefore, all subsequentanalysis(http://are considered descriptive 　　The study also assessed the efficacy of two additional doses of FF/UMEC/VI (100/31.25/25 and 200/31.25/25 mcg) relative to Relvar/Breo (FF/VI, 100/25 and 200/25) data showed that the two doses of FF/UMEC/VI have similar increases in FEV1 valley values with FF/UMEC/VI 100/62.5/25 and 200/62.5/25, with no difference in seizure rate security studies, the security profile of FF/UMEC/VI is consistent with the security profile of individual components and their combinations Adverse events were similar in all six treatment groups, with the most common adverse events including nasopharyngitis (13-15%), headache (5-9%), upper respiratory tract infections (3-6%) and bronchitis (3-5%)