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ERJ Open Res. 2016 May 26;2(2). pii: 00106-2015. eCollection 2016 Apr.

Add-on LABA in a separate inhaler as asthma step-up therapy versus increased dose of ICS or ICS/LABA combination inhaler.

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Academic Primary Care, University of Aberdeen, Aberdeen, UK; Observational and Pragmatic Research Institute, Singapore, Singapore.
Washington Hospital Center and George Washington University School of Medicine, Washington, DC, USA.
Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
University Paris Descartes (EA2511), Cochin Hospital Group (AP-HP), Paris, France.
University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
Emma Children's Hospital AMC, Amsterdam, The Netherlands.
Blizard Institute, Queen Mary University of London, London, UK.
Observational and Pragmatic Research Institute, Singapore, Singapore.
National Jewish Health and the University of Colorado Denver, Denver, CO, USA.


Asthma management guidelines recommend adding a long-acting β2-agonist (LABA) or increasing the dose of inhaled corticosteroid (ICS) as step-up therapy for patients with uncontrolled asthma on ICS monotherapy. However, it is uncertain which option works best, which ICS particle size is most effective, and whether LABA should be administered by separate or combination inhalers. This historical, matched cohort study compared asthma-related outcomes for patients (aged 12-80 years) prescribed step-up therapy as a ≥50% extrafine ICS dose increase or add-on LABA, via either a separate inhaler or a fine-particle ICS/LABA fixed-dose combination (FDC) inhaler. Risk-domain asthma control was the primary end-point in comparisons of cohorts matched for asthma severity and control during the baseline year. After 1:2 cohort matching, the increased extrafine ICS versus separate ICS+LABA cohorts included 3232 and 6464 patients, respectively, and the fine-particle ICS/LABA FDC versus separate ICS+LABA cohorts included 7529 and 15 058 patients, respectively (overall mean age 42 years; 61-62% females). Over one outcome year, adjusted OR (95% CI) for achieving asthma control were 1.25 (1.13-1.38) for increased ICS versus separate ICS+LABA and 1.06 (1.05-1.09) for ICS/LABA FDC versus separate ICS+LABA. For patients with asthma, increased dose of extrafine-particle ICS, or add-on LABA via ICS/LABA combination inhaler, is associated with significantly better outcomes than ICS+LABA via separate inhalers.

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