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
| Autor: | Chan Sun Park, Hee-Kyoo Kim, An-Soo Jang, Young-Hee Nam, Min Suk Yang, Jae-Woo Jung, You Sook, Hyouk-Soo Kwon, Bomi Seo, So-Young Park, Yoo Seob Shin, S. Lee, Young-Joo Cho, Jaechun Lee, So Young Park, Gyu Young Hur, Sae-Hoon Kim, Jae-Woo Kwon, Sun-Young Yoon, Hyun Jung Jin, Ji-Yong Moon, Woo-Jung Song, Tae Hoon Lee, Sujeong Kim, Sang-Ha Kim, Joo-Hee Kim, Tae-Bum Kim, Junghyun Kim, Hye-Kyung Park, Sang Hoon Kim, Jeong Hee Choi, Byoung-Whui Choi, Min-Hye Kim |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
education.field_of_study Intention-to-treat analysis Randomization business.industry medicine.drug_class Population medicine.disease Confidence interval law.invention 03 medical and health sciences 0302 clinical medicine 030228 respiratory system Randomized controlled trial law Internal medicine Bronchodilator Clinical endpoint Immunology and Allergy Medicine 030212 general & internal medicine business education Asthma |
| Zdroj: | The Journal of Allergy and Clinical Immunology: In Practice. 9:3638-3646.e3 |
| ISSN: | 2213-2198 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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