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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  • Additional Information
    • Affiliation:
      Crisor LLC Research, Clinical Research Institute of Southern Oregon, Medford, OR, USA
      GSK, Upper Providence, PA, USA
      GSK, Stockley Park West, Uxbridge, Middlesex, UK
      Asthma & Allergy Associates, P.C. and Research Center, Colorado Springs, CO, USA
      Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
      Bernstein Clinical Research Center, Cincinnati, OH, USA
      GSK, 980 Great West Road, Brentford, Middlesex, UK
    • Abstract:
      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; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo. No new safety signals were identified.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.
    • Journal Subset:
      Biomedical; Europe; UK & Ireland
    • ISSN:
      1465-9921
    • MEDLINE Info:
      PMID: NLM32532275 NLM UID: 101090633
    • Grant Information:
      n/a//GlaxoSmithKline/
    • Publication Date:
      In Process
    • Publication Date:
      20200617
    • DOI:
      10.1186/s12931-020-01400-5
    • Accession Number:
      143738177
  • Citations
    • ABNT:
      KERWIN, E. et al. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respiratory Research, [s. l.], v. 21, n. 1, p. 1–15, 2020. DOI 10.1186/s12931-020-01400-5. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143738177. Acesso em: 27 set. 2020.
    • AMA:
      Kerwin E, Pascoe S, Bailes Z, et al. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respiratory Research. 2020;21(1):1-15. doi:10.1186/s12931-020-01400-5
    • APA:
      Kerwin, E., Pascoe, S., Bailes, Z., Nathan, R., Bernstein, D., Dahl, R., von Maltzahn, R., Robbins, K., Fowler, A., & Lee, L. (2020). A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respiratory Research, 21(1), 1–15. https://doi.org/10.1186/s12931-020-01400-5
    • Chicago/Turabian: Author-Date:
      Kerwin, Edward, Steven Pascoe, Zelie Bailes, Robert Nathan, David Bernstein, Ronald Dahl, Robyn von Maltzahn, Kevin Robbins, Andrew Fowler, and Laurie Lee. 2020. “A Phase IIb, Randomised, Parallel-Group Study: The Efficacy, Safety and Tolerability of Once-Daily Umeclidinium in Patients with Asthma Receiving Inhaled Corticosteroids.” Respiratory Research 21 (1): 1–15. doi:10.1186/s12931-020-01400-5.
    • Harvard:
      Kerwin, E. et al. (2020) ‘A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids’, Respiratory Research, 21(1), pp. 1–15. doi: 10.1186/s12931-020-01400-5.
    • Harvard: Australian:
      Kerwin, E, Pascoe, S, Bailes, Z, Nathan, R, Bernstein, D, Dahl, R, von Maltzahn, R, Robbins, K, Fowler, A & Lee, L 2020, ‘A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids’, Respiratory Research, vol. 21, no. 1, pp. 1–15, viewed 27 September 2020, .
    • MLA:
      Kerwin, Edward, et al. “A Phase IIb, Randomised, Parallel-Group Study: The Efficacy, Safety and Tolerability of Once-Daily Umeclidinium in Patients with Asthma Receiving Inhaled Corticosteroids.” Respiratory Research, vol. 21, no. 1, June 2020, pp. 1–15. EBSCOhost, doi:10.1186/s12931-020-01400-5.
    • Chicago/Turabian: Humanities:
      Kerwin, Edward, Steven Pascoe, Zelie Bailes, Robert Nathan, David Bernstein, Ronald Dahl, Robyn von Maltzahn, Kevin Robbins, Andrew Fowler, and Laurie Lee. “A Phase IIb, Randomised, Parallel-Group Study: The Efficacy, Safety and Tolerability of Once-Daily Umeclidinium in Patients with Asthma Receiving Inhaled Corticosteroids.” Respiratory Research 21, no. 1 (June 12, 2020): 1–15. doi:10.1186/s12931-020-01400-5.
    • Vancouver/ICMJE:
      Kerwin E, Pascoe S, Bailes Z, Nathan R, Bernstein D, Dahl R, et al. A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids. Respiratory Research [Internet]. 2020 Jun 12 [cited 2020 Sep 27];21(1):1–15. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143738177