BACKGROUND AND OBJECTIVE: @entity7023 (' @entity7024 ') is a novel, inhaled long-acting muscarinic antagonist. Therapeutic effects of @entity7024 on @entity1030 ( @entity1030 ) have been demonstrated in Caucasian populations in several clinical trials. This was a randomized, double-blind, multi-centre phase-3 clinical trial to evaluate the efficacy and safety of @entity7024 in a Korean population. METHODS: A total of 263 Korean @entity1 with moderate-to-severe @entity1030 were randomized to receive @entity7024 (400    g, bd) (Genuai) or placebo via a dry-powder inhaler. The primary end point was change in trough forced expiratory volume in one second (FEV1 ) at 12 weeks. Other lung function measurements, @entity1030 exacerbation, health status (St George's Respiratory Questionnaire (SGRQ), dyspnoea ( @entity1353 ( @entity1353 ) and safety were assessed throughout the study period. RESULTS: A significant improvement in trough FEV1 from baseline was shown with @entity7024 compared with the placebo (0.126   L, P   <   0.0001). Significant improvements were also demonstrated in peak FEV1 (0.190   L, P   <   0.0001), SGRQ and @entity1353 . Furthermore, @entity7024 significantly reduced the prevalence of exacerbations ( @entity7024 , 5.4%; placebo, 15.6%, P   <   0.05), and the duration of exacerbations was shorter compared with placebo (rate ratio: 0.27; P   <   0.05). @entity7024 (400    g) was well tolerated and the prevalence of adverse events was comparable with the placebo. CONCLUSIONS: Inhaled @entity7024 (400    g) was shown to be safe and efficacious in Korean @entity1 with moderate-to-severe @entity1030 . CLINICAL TRIAL REGISTRATION: NCT01636401 at Clinicaltrials.gov.

Efficacy and safety of XXXX in @entity1 with @entity1030 : A phase 3 randomized clinical trial in a Korean population.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1353 :: ('MESH:D004417', 'Disease') :: ['Transition Dyspnea Index', 'TDI'] @entity7024 :: ('CHEBI:65346', 'Chemical') :: ['aclidinium', 'Aclidinium'] @entity1030 :: ('MESH:D029424', 'Disease') :: ['chronic obstructive pulmonary disease', 'COPD'] @entity7023 :: ('MESH:C542859', 'Chemical') :: ['Aclidinium bromide']
@entity7023 :: (MESH:C542859,Chemical) :: ['aclidinium bromide']
