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J Allergy Clin Immunol Pract. 2017 Sep - Oct;5(5):1378-1387.e5. doi: 10.1016/j.jaip.2017.02.006. Epub 2017 Mar 25.

A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma.

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National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton Hospital, London, United Kingdom.
Research in Real Life Ltd, Cambridge, United Kingdom; Optimum Patient Care Global Ltd, Cambridge, United Kingdom.
Cambridge Research Support Ltd, Cambridge, United Kingdom.
Optimum Patient Care, Cambridge, United Kingdom.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Research in Real Life Ltd, Cambridge, United Kingdom; Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom; Observational and Pragmatic Research Institute, Singapore. Electronic address:



Guidelines recommend reducing treatment in patients with well-controlled asthma after 3 months of stability. However, there is inadequate real-life data to guide physicians on therapy change in daily practice.


To assess asthma control after change to and step-down of fluticasone propionate/formoterol fumarate dihydrate (FP/FOR) in real-life patients.


In a randomized controlled, pragmatic, open-label trial, 225 well-controlled patients with asthma were randomized (1:2) to maintain high-dose fluticasone propionate/salmeterol xinafoate (FP/SAL, 1000/100 μg) or switch to FP/FOR (1000/40 μg) daily for 12 weeks (phase 1). One hundred sixteen patients stable on FP/FOR at week 12 were subsequently randomized (1:1) to maintain this therapy, or stepped down to FP/FOR (500/20 μg) daily for 12 weeks (phase 2). The primary end point was the 7-question Asthma Control Questionnaire (ACQ7) score.


In phase 1, FP/FOR (1000/40 μg) (n = 126) was noninferior to FP/SAL (1000/100 μg) (n = 73) for ACQ7 (difference in means, -0.12; 95% CI, -0.32 to 0.09). In phase 2, FP/FOR (500/20 μg) (n = 52) was noninferior to FP/FOR (1000/40 μg) (n = 52) for ACQ7 (difference in means, 0.01; 95% CI, -0.20 to 0.22). There was no significant difference in exacerbation rate between the groups in either phase. However, 1 to 2 exacerbations in 12 months before phase 1 were associated with the occurrence of an exacerbation after step-down (P = .007).


In patients with well-controlled asthma, a change from FP/SAL to FP/FOR did not compromise asthma control. Step-down of FP/FOR was well tolerated; however, in contrast to current guidelines, our data suggest caution in stepping down patients uncontrolled in the last 12 months. Larger step-down studies are required to confirm these findings.


ACQ7; Antiasthmatic agents; Biomarkers; Combination therapy; Fluticasone; Formoterol; Fractional exhaled nitric oxide; Inhaled corticosteroids; Pragmatic trials; Salmeterol; Step-down

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