Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial.
Adrenergic beta-2 Receptor Agonists
/ administration & dosage
Aged
Albuterol
/ administration & dosage
Bronchodilator Agents
/ administration & dosage
Double-Blind Method
Drug Therapy, Combination
Female
Forced Expiratory Volume
/ drug effects
Humans
Male
Middle Aged
Prospective Studies
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Treatment Outcome
(3–10): dual bronchodilators
COPD
Lung function
Rescue therapy
SABA
Salbutamol
Symptoms
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
22 Oct 2020
22 Oct 2020
Historique:
received:
24
04
2020
accepted:
09
07
2020
entrez:
23
10
2020
pubmed:
24
10
2020
medline:
21
8
2021
Statut:
epublish
Résumé
Short-acting β The Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25 μg, once-daily umeclidinium 62.5 μg or twice-daily salmeterol 50 μg for 24 weeks. Pre-specified subgroup analyses stratified patients by median baseline SABA use (low, < 1.5 puffs/day; high, ≥1.5 puffs/day) to examine change from baseline in trough forced expiratory volume in 1 s (FEV At baseline, patients in the high SABA use subgroup (mean: 3.91 puffs/day, n = 1212) had more severe airflow limitation, were more symptomatic and had worse health status versus patients in the low SABA use subgroup (0.39 puffs/day, n = 1206). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV In high SABA users, there may be a smaller difference in treatment response between dual- and mono-bronchodilator therapy; the reasons for this require further investigation. SABA use may be a confounding factor in bronchodilator trials and in high SABA users; changes in SABA use may be considered a robust symptom outcome. GlaxoSmithKline (study number 201749 [NCT03034915]).
Sections du résumé
BACKGROUND
BACKGROUND
Short-acting β
METHODS
METHODS
The Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25 μg, once-daily umeclidinium 62.5 μg or twice-daily salmeterol 50 μg for 24 weeks. Pre-specified subgroup analyses stratified patients by median baseline SABA use (low, < 1.5 puffs/day; high, ≥1.5 puffs/day) to examine change from baseline in trough forced expiratory volume in 1 s (FEV
RESULTS
RESULTS
At baseline, patients in the high SABA use subgroup (mean: 3.91 puffs/day, n = 1212) had more severe airflow limitation, were more symptomatic and had worse health status versus patients in the low SABA use subgroup (0.39 puffs/day, n = 1206). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV
CONCLUSIONS
CONCLUSIONS
In high SABA users, there may be a smaller difference in treatment response between dual- and mono-bronchodilator therapy; the reasons for this require further investigation. SABA use may be a confounding factor in bronchodilator trials and in high SABA users; changes in SABA use may be considered a robust symptom outcome.
FUNDING
BACKGROUND
GlaxoSmithKline (study number 201749 [NCT03034915]).
Identifiants
pubmed: 33092591
doi: 10.1186/s12931-020-01451-8
pii: 10.1186/s12931-020-01451-8
pmc: PMC7579818
doi:
Substances chimiques
Adrenergic beta-2 Receptor Agonists
0
Bronchodilator Agents
0
Albuterol
QF8SVZ843E
Banques de données
ClinicalTrials.gov
['NCT03034915']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
280Subventions
Organisme : GlaxoSmithKline
ID : study number 201749
Références
BMC Pulm Med. 2015 Aug 21;15:97
pubmed: 26293575
Int J Chron Obstruct Pulmon Dis. 2017 Jan 19;12:367-381
pubmed: 28176892
Respir Care. 2018 Jun;63(6):818-831
pubmed: 29794213
Pulm Pharmacol Ther. 2018 Apr;49:11-19
pubmed: 29277690
J Med Econ. 2017 Jan;20(1):28-36
pubmed: 27564685
Respir Res. 2019 Oct 30;20(1):238
pubmed: 31666084
Lancet Respir Med. 2018 Feb;6(2):117-126
pubmed: 29331313
Lancet Respir Med. 2019 Sep;7(9):745-756
pubmed: 31281061
Prim Care Respir J. 2011 Mar;20(1):46-53
pubmed: 20886200
Eur Respir J. 2002 Mar;19(3):398-404
pubmed: 11936514
Eur Respir J. 2004 Jun;23(6):932-46
pubmed: 15219010
Pharmacol Rev. 2012 Jul;64(3):450-504
pubmed: 22611179
Respir Res. 2014 Oct 07;15:124
pubmed: 25287629
Respir Res. 2019 Mar 26;20(1):60
pubmed: 30914064
Respir Res. 2017 May 8;18(1):86
pubmed: 28482883