The online version of this article (doi:10.1186/s12890-015-0092-1) contains supplementary material, which is available to authorized users.
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.
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.
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.
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.
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.
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.
NCT01822899 Registration date: March 28, 2013
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
Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html (2014). Accessed 17 Dec 2014.
Anoro EU summary of product characteristics, 16 May 2014. http://www.medicines.ie/medicine/16007/SPC/ANORO+55+micrograms+22+micrograms+inhalation+powder,+pre-dispensed/ (2014). Accessed 17 Dec 2014.
ANORO US prescribing information, May 2014. https://www.gsksource.com/gskprm/htdocs/documents/ANORO-ELLIPTA-PI-MG.PDF (2014). Accessed 17 Dec 2014.
Seretide EU summary of product characteristics. http://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler (2013). Accessed 17 Dec 2014.
Singh D, Worsley S, Zhu C-Q, Hardaker L, Church A. Umeclidinium/vilanterol (UMEC/VI) once daily (OD) vs fluticasone/salmeterol combination (FSC) twice daily (BD) in patients with moderate-to-severe COPD and infrequent COPD exacerbations. Eur Respir J. 2014;44 Suppl 58:P290.
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended (latest) by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. http://www.wma.net/en/30publications/10policies/b3/index.html (2008). Accessed 17 Dec 2014.
International Conference on Harmonisation Tripartite Guideline: Guidance for Good Clinical Practice E6 (R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (1996). Accessed 17 Dec 2014.
Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014;2:472–86. CrossRefPubMed
Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D’Andrea P, Chen H, et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013;1:51–60. CrossRefPubMed
- Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial
- BioMed Central
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
Mail Icon II