Pragmatic Randomized Controlled Trial for Stepping Down Asthma Controller Treatment in Patients Controlled with Low-Dose Inhaled Corticosteroid and Long-Acting β2-Agonist: Step-Down of Intervention and Grade in Moderate Asthma Study
- Authors
- Kim, S.-H.; Lee, T.; Jang, A.-S.; Park, C.S.; Jung, J.-W.; Kim, M.-H.; Kwon, J.-W.; Moon, J.-Y.; Yang, M.-S.; Lee, J.; Choi, J.-H.; Shin, Y.S.; Kim, H.-K.; Kim, S.; Kim, J.-H.; Lee, S.-Y.; Nam, Y.-H.; Kim, S.-H.; Kim, T.-B.
- Issue Date
- Oct-2021
- Publisher
- American Academy of Allergy, Asthma and Immunology
- Keywords
- Asthma; Controller treatment; Inhaled corticosteroid; Long-acting β2-agonist; Step-down
- Citation
- Journal of Allergy and Clinical Immunology: In Practice, v.9, no.10, pp 3638 - 3646.e3
- Journal Title
- Journal of Allergy and Clinical Immunology: In Practice
- Volume
- 9
- Number
- 10
- Start Page
- 3638
- End Page
- 3646.e3
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/54526
- DOI
- 10.1016/j.jaip.2021.04.042
- ISSN
- 2213-2198
2213-2201
- Abstract
- Background: Current asthma guidelines recommend stepping down controller treatment when the condition is well-controlled for a certain time. However, the optimal step-down strategy for well-controlled patients receiving a low-dose inhaled corticosteroid (ICS) with a long-acting β2-agonist (LABA) remains unclear. Objective: This study was a randomized, open-label, three-arm, parallel pragmatic trial comparing two kinds of step-down approaches for maintaining treatment. Methods: Adults with asthma who were aged 18 years or older, and who had been stable with low-dose ICS/LABA for at least 3 months, were enrolled. Subjects (n = 225) were randomly allocated into one of three groups (maintaining low-dose ICS/LABA [G1], discontinuing LABA [G2], and reducing ICS/LABA to once daily [G3]), and were observed for 6 months. The primary end point was a change in Asthma Control Test (ACT) scores between randomization and the final 6-month follow-up. Results: The change in ACT was analyzed in the per-protocol population; noninferiority was not demonstrated in either step-down group compared with the maintenance group (95% confidence interval of the difference, G2 vs G1 = –1.40-0.55; G3 vs G1 = –1.19-0.77). Although over 90% of patients were fine, higher rates of treatment failure were observed in step-down groups (G1: 0%; G2: 9.46%; and G3: 9.09%; P =.027). There were no significant differences between step-down approaches in terms of ACT change or treatment failure. Conclusions: Both step-down methods were not noninferior to maintenance of treatment. Step-down therapy can be attempted when patients are stable, but appropriate monitoring and supervision are necessary with precautions regarding loss of disease control. © 2021 American Academy of Allergy, Asthma & Immunology
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