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Review
. 2023 Jan-Dec:20:14799731231202257.
doi: 10.1177/14799731231202257.

How can the findings of the EMAX trial on long-acting bronchodilation in chronic obstructive pulmonary disease be applied in the primary care setting?

Edward M Kerwin  1 , Paul W Jones  2 , Leif H Bjermer  3 , François Maltais  4 , Isabelle H Boucot  2 , Ian P Naya  2 , David A Lipson  5   6 , Chris Compton  2 , Lee Tombs  7 , Claus F Vogelmeier  8
Affiliations
Review

How can the findings of the EMAX trial on long-acting bronchodilation in chronic obstructive pulmonary disease be applied in the primary care setting?

Edward M Kerwin et al. Chron Respir Dis. 2023 Jan-Dec.

Abstract

This review addresses outstanding questions regarding initial pharmacological management of chronic obstructive pulmonary disease (COPD). Optimizing initial treatment improves clinical outcomes in symptomatic patients, including those with low exacerbation risk. Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) dual therapy improves lung function versus LAMA or LABA monotherapy, although other treatment benefits have been less consistently observed. The benefits of dual bronchodilation in symptomatic patients with COPD at low exacerbation risk, and its duration of efficacy and cost effectiveness in this population, are not yet fully established. Questions remain on the impact of baseline symptom severity, prior treatment, degree of reversibility to bronchodilators, and smoking status on responses to dual bronchodilator treatment. Using evidence from EMAX (NCT03034915), a 6-month trial comparing the LAMA/LABA combination umeclidinium/vilanterol with umeclidinium and salmeterol monotherapy in symptomatic patients with COPD at low exacerbation risk who were inhaled corticosteroid-naïve, we describe how these findings can be applied in primary care.

Keywords: Symptomatic chronic obstructive pulmonary disease; initial maintenance therapy; long-acting bronchodilators; long-acting muscarinic antagonist/long-acting β2-agonist dual therapy; primary care.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EMK has served on advisory boards, speaker panels or received travel reimbursement for Amphastar, AstraZeneca, Boehringer Ingelheim, Connect Biopharma, GSK, Mylan, Novartis, Pearl, Sunovion, Teva and Theravance, and has received consulting fees from Cipla and GSK. PWJ is an Emeritus Professor of Respiratory Medicine at St George’s, University of London, and a former full-time employee of GSK at the time of protocol development and contributed to study design and protocol on behalf of GSK. He is a part-time consultant at GSK and holds stocks/shares. IHB, DAL and CC are employees of GSK and hold stock and shares in GSK. LHB has received honoraria for giving a lecture or attending an advisory board for Airsonett, ALK-Abelló, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Meda, Novartis and Teva. FM has received research grants for participating in multicenter trials for AstraZeneca, Boehringer Ingelheim, GSK, Sanofi and Novartis, and has received unrestricted research grants and personal fees from Boehringer Ingelheim, Grifols and Novartis. IPN was an employee of GSK at the time of the EMAX trial, holds stocks and shares in GSK, and was a contingent worker on assignment at AstraZeneca. LT is a contingent worker on assignment at GSK. CFV has received grants from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Grifols, Mundipharma, Novartis, and the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), and has received personal fees from AstraZeneca, Boehringer Ingelheim, Berlin Chemie/Menarini, Chiesi, CSL Behring, GSK, Grifols, MedUpdate, Novartis and Teva. DISKUS and ELLIPTA are owned by/licensed to the GSK group of companies.

Figures

Figure 1.
Figure 1.
EMAX study design. CAT, COPD Assessment Test; CID, clinically important deterioration; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms–COPD; FEV1, forced expiratory volume in 1 s; SAC-TDI, self-administered computerized-Transition Dyspnea Index; SAL, salmeterol; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.
Figure 2.
Figure 2.
Lung function improvements in dual versus monotherapy in symptomatic patients with low exacerbation risk. The primary analysis (including lung function, breathlessness, and rescue medication use) was a mixed model repeated measures analysis based on a two-sided hypothesis testing approach. This article is available under a CC-BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/). CI, confidence interval; FEV1, forced expiratory volume in 1 s; SAL, salmeterol; UMEC, umeclidinium; VI, vilanterol.
Figure 3.
Figure 3.
Breathlessness (a) and rescue medication-free days (b) in dual versus monotherapy in symptomatic patients with low exacerbation risk. Data shown are (a) mean (95% CI) SAC-TDI score and (b) mean (95% CI) percentage change from baseline in rescue medication-free days. The primary analysis (including lung function, breathlessness, and rescue medication use) was a mixed model repeated measures analysis based on a two-sided hypothesis testing approach. This article is available under a CC-BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/). CFB, change from baseline; CI, confidence interval; SAC-TDI, self-administered computerized-Transition Dyspnea Index; SAL, salmeterol; UMEC, umeclidinium; VI, vilanterol.
Figure 4.
Figure 4.
Simplified algorithm for pharmacological management of patients with symptomatic COPD in primary care. *For patients presenting with asthma features, ICS-containing regiments should be considered; †Consideration should be given when prescribing patients with monotherapy, since dual LAMA/LABA therapy has greater efficacy across a number of outcomes, a similar safety profile, and is cost-effective compared with monotherapy. CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist mMRC, modified Medical Research Council; SABA, short-acting β2-agonist.
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