Skip to main content
main-content

01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Pulmonary Medicine 1/2015

Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial

Zeitschrift:
BMC Pulmonary Medicine > Ausgabe 1/2015
Autoren:
Dave Singh, Sally Worsley, Chang-Qing Zhu, Liz Hardaker, Alison Church
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12890-015-0092-1) contains supplementary material, which is available to authorized users.

Competing interests

DS has served as consultant to Almirall, AstraZeneca, Boehringer Ingleheim, Chiesi, Cipla, GSK, Novartis, Nycomed and Roche; has received research grants from Almirall, AstraZeneca, Boehringer Ingleheim, Chiesi, Cipla, GSK, Novartis, Nycomed and Roche; has received payment for lectures including service on speakers bureaus from Almirall, AstraZeneca, Boehringer Ingleheim, Chiesi, Cipla, GSK, Novartis, Nycomed, Roche and Takeda. All other authors (SW, C-QZ, LH and AC) are employed by and hold stock in GSK.

Authors’ contribution

DS contributed to the conception and design of the study and data interpretation. SW contributed to the conception and design of the study, acquisition of data and data interpretation. C-QZ contributed to the data analyses and data interpretation. LH contributed to the conception and design of the study and data interpretation. AC contributed to the conception and design of the study and data interpretation. Employees of the sponsor were involved in the conception, design and conduct of the study, and in data collection and analysis. All authors, including authors employed by the sponsor, participated in the development of the manuscript, and had access to the data from the study. The decision to submit for publication was that of the authors alone.

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 1:1 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
Zusatzmaterial
Additional file 1: List of institutions and Independent Ethics Committees/Institutional Review Boards for Study DB2116134. (DOC 122 kb)
12890_2015_92_MOESM1_ESM.doc
Additional file 2: Study design Figure. Abbreviations: BDI, Baseline Dyspnoea Index; CAT, COPD Assessment Test; FP/SAL, fluticasone propionate/salmeterol; FEV1, forced expiratory volume in 1 s; ITT, intent-to-treat; mMRC, modified Medical Research Council SGRQ-C, St George’s Respiratory Questionnaire for COPD; TDI, Transition Dyspnoea Index; UMEC, umeclidinium; VI, vilanterol. (PDF 425 kb)
12890_2015_92_MOESM2_ESM.pdf
Additional file 3: Online supplement. Online supplement containing additional details regarding COPD medications, treatment compliance and adverse events. (DOC 30 kb)
12890_2015_92_MOESM3_ESM.doc
Additional file 4: Table S1. Proportion of patients achieving an increase FEV1 ≥ 0.100 L above baseline at various times post-dose on Day 1 (ITT population; post hoc analyses). (DOC 38 kb)
12890_2015_92_MOESM4_ESM.doc
Additional file 5: Table S2. Results from the analyses reporting proportions of patients achieving lung function improvements for selected other endpoints (ITT population). (DOC 37 kb)
12890_2015_92_MOESM5_ESM.doc
Additional file 6: Table S3. Results from the analyses of FVC other endpoints (selected) (ITT population). (DOC 43 kb)
12890_2015_92_MOESM6_ESM.doc
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2015

BMC Pulmonary Medicine 1/2015 Zur Ausgabe

Neu im Fachgebiet Innere Medizin

Meistgelesene Bücher aus der Inneren Medizin

2017 | Buch

Rheumatologie aus der Praxis

Entzündliche Gelenkerkrankungen – mit Fallbeispielen

Dieses Fachbuch macht mit den wichtigsten chronisch entzündlichen Gelenk- und Wirbelsäulenerkrankungen vertraut. Anhand von über 40 instruktiven Fallbeispielen werden anschaulich diagnostisches Vorgehen, therapeutisches Ansprechen und der Verlauf …

Herausgeber:
Rudolf Puchner

2016 | Buch

Ambulant erworbene Pneumonie

Was, wann, warum – Dieses Buch bietet differenzierte Diagnostik und Therapie der ambulant erworbenen Pneumonie zur sofortigen sicheren Anwendung. Entsprechend der neuesten Studien und Leitlinien aller wichtigen Fachgesellschaften.

Herausgeber:
Santiago Ewig

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Innere Medizin und bleiben Sie gut informiert – ganz bequem per eMail.

© Springer Medizin 

Bildnachweise