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A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids

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العنوان: A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids
المؤلفون: Zelie Bailes, Steven Pascoe, Laurie Lee, Edward Kerwin, Robyn von Maltzahn, Andrew Fowler, David I. Bernstein, Robert A. Nathan, Kevin Robbins, Ronald Dahl
المصدر: Respiratory Research
Respiratory Research, Vol 21, Iss 1, Pp 1-15 (2020)
بيانات النشر: BioMed Central, 2020.
سنة النشر: 2020
مصطلحات موضوعية: Spirometry, Male, Quinuclidines, medicine.drug_class, Population, Placebo, Fluticasone propionate, 03 medical and health sciences, 0302 clinical medicine, Forced expiratory volume in 1 s, Double-Blind Method, Inhaled corticosteroid, Bronchodilator, Forced Expiratory Volume, Administration, Inhalation, Medicine, Umeclidinium, Humans, 030212 general & internal medicine, education, Glucocorticoids, Asthma, lcsh:RC705-779, education.field_of_study, medicine.diagnostic_test, business.industry, Research, lcsh:Diseases of the respiratory system, Drug Tolerance, Middle Aged, medicine.disease, Bronchodilator Agents, Long-acting muscarinic antagonist, Treatment Outcome, 030228 respiratory system, Tolerability, Anesthesia, Salbutamol, Fluticasone, Drug Therapy, Combination, Female, business, medicine.drug
الوصف: Background Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist. 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 (FEV1) and clinic FEV1 3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV1, evening FEV1, morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study. 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 FEV1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; pp1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; pp 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 GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.
اللغة: English
تدمد: 1465-993X
1465-9921
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::18a6c1045320a84d2f1143254bd35a39
http://europepmc.org/articles/PMC7291639
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....18a6c1045320a84d2f1143254bd35a39
قاعدة البيانات: OpenAIRE
الوصف
تدمد:1465993X
14659921