Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population.
Respirology
; 20(8): 1222-8, 2015 Nov.
Article
en En
| MEDLINE
| ID: mdl-26370136
ABSTRACT
BACKGROUND AND OBJECTIVE:
Aclidinium bromide ('aclidinium') is a novel, inhaled long-acting muscarinic antagonist. Therapeutic effects of aclidinium on chronic obstructive pulmonary disease (COPD) 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 aclidinium in a Korean population.METHODS:
A total of 263 Korean patients with moderate-to-severe COPD were randomized to receive aclidinium (400 µg, 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, COPD exacerbation, health status (St George's Respiratory Questionnaire (SGRQ), dyspnoea (Transition Dyspnea Index (TDI) and safety were assessed throughout the study period.RESULTS:
A significant improvement in trough FEV1 from baseline was shown with aclidinium 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 TDI. Furthermore, aclidinium significantly reduced the prevalence of exacerbations (aclidinium, 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). Aclidinium (400 µg) was well tolerated and the prevalence of adverse events was comparable with the placebo.CONCLUSIONS:
Inhaled aclidinium (400 µg) was shown to be safe and efficacious in Korean patients with moderate-to-severe COPD. CLINICAL TRIAL REGISTRATION NCT01636401 at Clinicaltrials.gov.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Tropanos
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Antagonistas Muscarínicos
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Enfermedad Pulmonar Obstructiva Crónica
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Risk_factors_studies
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
Respirology
Año:
2015
Tipo del documento:
Article