Sae-Hoon Kim1, Taehoon Lee2, An-Soo Jang3, Chan Sun Park4, Jae-Woo Jung5, Min-Hye Kim6, Jae-Woo Kwon7, Ji-Yong Moon8, Min-Suk Yang9, Jaechun Lee10, Jeong-Hee Choi11, Yoo Seob Shin12, Hee-Kyoo Kim13, Sujeong Kim14, Joo-Hee Kim15, Suh-Young Lee16, Young-Hee Nam17, Sang-Hoon Kim18, Tae-Bum Kim19. 1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. 2. Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. 3. Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea. 4. Department of Internal Medicine, Inje Unversity, Haeundae Paik Hospital, Busan, Korea. 5. Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea. 6. Department of Internal Medicine, Ewha Woman University College of Medicine, Seoul, Korea. 7. Department of Internal Medicine, Kangwon University School of Medicine, Chuncheon, Korea. 8. Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea. 9. Department of Internal Medicine, SMG-SNU Borame Medical Center, Seoul, Korea. 10. Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea. 11. Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea; Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea. 12. Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea. 13. Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea. 14. Department of Internal Medicine, School of Medicine Kyungbook National University, Daegu, Korea. 15. Department of Internal Medicine, Hallym University College of Medicine, Anyang, Korea. 16. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. 17. Department of Internal Medicine, Dong-A University School of Medicine, Busan, Korea. 18. Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea. 19. Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: tbkim@amc.seoul.kr.
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.
RCT Entities:
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.