Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial.
BMC Pulm Med
; 15: 91, 2015 Aug 19.
Article
en En
| MEDLINE
| ID: mdl-26286141
ABSTRACT
BACKGROUND:
Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta2 agonist [LABA]) and the LABA/inhaled corticosteroid fluticasone propionate/salmeterol (FP/SAL) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD). This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment.METHODS:
Patients (n = 717) were randomised 11 to once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 500/50 mcg. Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety.RESULTS:
Improvements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval 0.046-0.113; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (both p < 0.001). UMEC/VI statistically significantly improved all other lung function measures versus FP/SAL. Both treatments demonstrated a clinically meaningful improvement in symptoms (Transition Dyspnoea Index ≥1 unit) and QoL (St George's Respiratory Questionnaire Total score ≥4 unit decrease from baseline) over 12 weeks. The incidence of adverse events was 28 % (UMEC/VI) and 29 % (FP/SAL); nasopharyngitis and headache were most common.CONCLUSIONS:
Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in significant and sustained improvements in lung function versus twice-daily FP/SAL 500/50 mcg in patients with moderate-to-severe COPD and with no exacerbations in the year prior to enrolment. TRIAL REGISTRATION NCT01822899 Registration date March 28, 2013.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Quinuclidinas
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Enfermedad Pulmonar Obstructiva Crónica
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Combinación Fluticasona-Salmeterol
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
BMC Pulm Med
Año:
2015
Tipo del documento:
Article
País de afiliación:
Reino Unido