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

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Title: A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma.
Author(s): Usmani, OS
Kemppinen, A
Gardener, E
Thomas, V
Konduru, PR
Callan, C
McLoughlin, A
Woodhead, V
Brady, A
Juniper, EF
Barnes, PJ
Price, D
Item Type: Journal Article
Abstract: BACKGROUND: 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. OBJECTIVE: To assess asthma control after change to and step-down of fluticasone propionate/formoterol fumarate dihydrate (FP/FOR) in real-life patients. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
Publication Date: 25-Mar-2017
Date of Acceptance: 10-Feb-2017
URI: http://hdl.handle.net/10044/1/46154
DOI: 10.1016/j.jaip.2017.02.006
ISSN: 2213-2198
Publisher: Elsevier
Start Page: 1378
End Page: 1387.e5
Journal / Book Title: Journal of Allergy and Clinical Immunology: In Practice
Volume: 5
Issue: 5
Keywords: Science & Technology
Life Sciences & Biomedicine
Allergy
Immunology
ACQ7
Biomarkers
Combination therapy
Fluticasone
Formoterol
Fractional exhaled nitric oxide
Inhaled corticosteroids
Pragmatic trials
Salmeterol
Step-down
Antiasthmatic agents
INHALED CORTICOSTEROID-THERAPY
EXHALED NITRIC-OXIDE
PNEUMONIA
QUESTIONNAIRE
EXACERBATION
METAANALYSIS
VALIDATION
MARKERS
RISK
ACQ7
Antiasthmatic agents
Biomarkers
Combination therapy
Fluticasone
Formoterol
Fractional exhaled nitric oxide
Inhaled corticosteroids
Pragmatic trials
Salmeterol
Step-down
Publication Status: Published
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine



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