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Randomized Controlled Trial
. 2021 Oct;9(10):3638-3646.e3.
doi: 10.1016/j.jaip.2021.04.042. Epub 2021 May 1.

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

Sae-Hoon Kim  1 , Taehoon Lee  2 , An-Soo Jang  3 , Chan Sun Park  4 , Jae-Woo Jung  5 , Min-Hye Kim  6 , Jae-Woo Kwon  7 , Ji-Yong Moon  8 , Min-Suk Yang  9 , Jaechun Lee  10 , Jeong-Hee Choi  11 , Yoo Seob Shin  12 , Hee-Kyoo Kim  13 , Sujeong Kim  14 , Joo-Hee Kim  15 , Suh-Young Lee  16 , Young-Hee Nam  17 , Sang-Hoon Kim  18 , Tae-Bum Kim  19 ; Cohort for Reality and Evolution of Adult Asthma (COREA) Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Sae-Hoon Kim et al. J Allergy Clin Immunol Pract. 2021 Oct.

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.

Keywords: Asthma; Controller treatment; Inhaled corticosteroid; Long-acting β(2)-agonist; Step-down.

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