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Pragmatic Randomized Controlled Trial for Stepping Down Asthma Controller Treatment in Patients Controlled with Low-Dose Inhaled Corticosteroid and Long-Acting beta(2)-Agonist: Step-Down of Intervention and Grade in Moderate Asthma Study
- Title
- Pragmatic Randomized Controlled Trial for Stepping Down Asthma Controller Treatment in Patients Controlled with Low-Dose Inhaled Corticosteroid and Long-Acting beta(2)-Agonist: Step-Down of Intervention and Grade in Moderate Asthma Study
- Authors
- Kim, Sae-Hoon; Lee, Taehoon; Jang, An-Soo; Park, Chan Sun; Jung, Jae-Woo; Kim, Min-Hye; Kwon, Jae-Woo; Moon, Ji-Yong; Yang, Min-Suk; Lee, Jaechun; Choi, Jeong-Hee; Shin, Yoo Seob; Kim, Hee-Kyoo; Kim, Sujeong; Kim, Joo-Hee; Lee, Suh-Young; Nam, Young-Hee; Kim, Sang-Hoon; Kim, Tae-Bum|Cohort Reality Evolution Adult Ast
- Ewha Authors
- 김민혜
- SCOPUS Author ID
- 김민혜
- Issue Date
- 2021
- Journal Title
- JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
- ISSN
- 2213-2198
2213-2201
- Citation
- JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE vol. 9, no. 10, pp. 3638 - +
- Keywords
- Asthma; Controller treatment; Inhaled corticosteroid; Long-acting beta(2)-agonist; Step-down
- Publisher
- ELSEVIER
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- 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 beta(2)-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; non-inferiority 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. (C) 2021 American Academy of Allergy, Asthma & Immunology
- DOI
- 10.1016/j.jaip.2021.04.042
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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