Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD : a post hoc analysis of the EMAX randomised controlled trial
(2020) In Therapeutic Advances in Respiratory Disease 14.- Abstract
Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use... (More)
Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population (n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section.
(Less)
- author
- Kerwin, Edward M. ; Boucot, Isabelle H. ; Vogelmeier, Claus F. ; Maltais, Francois ; Naya, Ian P. ; Tombs, Lee ; Jones, Paul W. ; Lipson, David A. ; Keeley, Tom and Bjermer, Leif LU
- organization
- publishing date
- 2020-05-28
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- bronchodilator therapy, COPD, E-RS:COPD, rescue medication, symptoms
- in
- Therapeutic Advances in Respiratory Disease
- volume
- 14
- publisher
- SAG
- external identifiers
-
- pmid:32462979
- scopus:85085539669
- ISSN
- 1753-4658
- DOI
- 10.1177/1753466620926949
- language
- English
- LU publication?
- yes
- id
- acaf4887-f391-4f1d-b362-0649d5bc2812
- date added to LUP
- 2020-06-17 13:30:45
- date last changed
- 2025-04-04 14:43:27
@article{acaf4887-f391-4f1d-b362-0649d5bc2812,
abstract = {{<p>Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population (n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section.</p>}},
author = {{Kerwin, Edward M. and Boucot, Isabelle H. and Vogelmeier, Claus F. and Maltais, Francois and Naya, Ian P. and Tombs, Lee and Jones, Paul W. and Lipson, David A. and Keeley, Tom and Bjermer, Leif}},
issn = {{1753-4658}},
keywords = {{bronchodilator therapy; COPD; E-RS:COPD; rescue medication; symptoms}},
language = {{eng}},
month = {{05}},
publisher = {{SAG}},
series = {{Therapeutic Advances in Respiratory Disease}},
title = {{Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD : a post hoc analysis of the EMAX randomised controlled trial}},
url = {{http://dx.doi.org/10.1177/1753466620926949}},
doi = {{10.1177/1753466620926949}},
volume = {{14}},
year = {{2020}},
}