A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids.
Administration, Inhalation
Asthma
/ drug therapy
Bronchodilator Agents
/ administration & dosage
Double-Blind Method
Drug Therapy, Combination
Drug Tolerance
Female
Fluticasone
/ administration & dosage
Forced Expiratory Volume
/ drug effects
Glucocorticoids
/ administration & dosage
Humans
Male
Middle Aged
Quinuclidines
/ administration & dosage
Treatment Outcome
Asthma
Forced expiratory volume in 1 s
Inhaled corticosteroid
Long-acting muscarinic antagonist
Umeclidinium
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
12 Jun 2020
12 Jun 2020
Historique:
received:
01
11
2019
accepted:
19
05
2020
entrez:
14
6
2020
pubmed:
14
6
2020
medline:
7
5
2021
Statut:
epublish
Résumé
Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist. This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg). GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.
Sections du résumé
BACKGROUND
BACKGROUND
Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist.
METHODS
METHODS
This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV
RESULTS
RESULTS
The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV
CONCLUSIONS
CONCLUSIONS
UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg).
TRIAL REGISTRATION
BACKGROUND
GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.
Identifiants
pubmed: 32532275
doi: 10.1186/s12931-020-01400-5
pii: 10.1186/s12931-020-01400-5
pmc: PMC7291639
doi:
Substances chimiques
Bronchodilator Agents
0
GSK573719
0
Glucocorticoids
0
Quinuclidines
0
Fluticasone
CUT2W21N7U
Banques de données
ClinicalTrials.gov
['NCT03012061']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
148Subventions
Organisme : GlaxoSmithKline
ID : n/a
Références
N Engl J Med. 2010 Oct 28;363(18):1715-26
pubmed: 20979471
Respir Med. 2015 May;109(5):547-56
pubmed: 25676887
COPD. 2005 Mar;2(1):111-24
pubmed: 17136971
Ann Allergy Asthma Immunol. 2016 Jun;116(6):565-70
pubmed: 27117053
Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9
pubmed: 23026438
Telemed J E Health. 2013 Dec;19(12):897-903
pubmed: 24083367
Thorax. 2014 Apr;69(4):312-9
pubmed: 24253831
Respir Res. 2014 Oct 07;15:124
pubmed: 25287629
Lancet Respir Med. 2017 Sep;5(9):691-706
pubmed: 28822787
J Clin Epidemiol. 1994 Jan;47(1):81-7
pubmed: 8283197
Respir Med. 2015 Jan;109(1):54-62
pubmed: 25452139
Thorax. 2014 May;69(5):443-9
pubmed: 24595666
Respir Res. 2019 May 31;20(1):107
pubmed: 31151458
N Engl J Med. 2012 Sep 27;367(13):1198-207
pubmed: 22938706
Proc Natl Acad Sci U S A. 2007 Oct 2;104(40):15858-63
pubmed: 17898169
Am J Respir Crit Care Med. 2016 Oct 15;194(8):989-997
pubmed: 27089018
J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61
pubmed: 25213048
Respir Med. 2005 May;99(5):553-8
pubmed: 15823451
Eur Respir J. 2002 Mar;19(3):398-404
pubmed: 11936514
Respir Med. 2008 Oct;102(10):1385-91
pubmed: 18632258
COPD. 2005 Mar;2(1):75-9
pubmed: 17136966
Eur Respir Rev. 2012 Mar 1;21(123):66-74
pubmed: 22379176
Lancet Respir Med. 2015 May;3(5):367-76
pubmed: 25682232
Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99
pubmed: 19535666
Am J Respir Crit Care Med. 2015 Jul 15;192(2):209-18
pubmed: 25922973
Respir Med. 2017 Oct;131:148-157
pubmed: 28947022
J Allergy Clin Immunol. 2011 Aug;128(2):308-14
pubmed: 21636120