Respirology (Carlton, Vic.) · 2025
Treatable Trait Guided Asthma Management: A Feasibility Study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Fingleton James, McLachlan Rob, Sparks Jenny, Beasley Richard, Agustí Alvar, Gibson Peter G, Pavord Ian D, Hardy Jo, Weatherall Mark, Eathorne Allie, McDonald Vanessa M, Treatable Traits Study Group
Аннотация
BACKGROUND AND OBJECTIVES: Treatable trait-based personalised medicine improves outcomes in severe asthma clinics. We assessed the feasibility of a randomised controlled trial (RCT) of protocolised treatable trait-guided asthma management in patients not under a severe asthma clinic.
METHODS: Ten week single-group cohort study. Participants had a doctor's diagnosis of asthma, Asthma Control Questionnaire-5 (ACQ-5) score > 1, and ≥ 1 exacerbation in the last year.
INTERVENTION: biomarker-guided asthma medication according to a protocolised algorithm, targeting traits of type-2 inflammation and airflow obstruction. Feasibility outcomes: recruitment rates, acceptability of intervention, willingness to enrol in an RCT, need for 'extended' trait assessment after 10 weeks, and estimation of trait prevalence.
RESULTS: Recruitment ceased with 29/50 participants after 14 months due to difficulties associated with COVID-19. Recruitment rate: 29/118 (25%) of those invited to participate (95% CI 17 to 33). 24/26 (92%) participants found the intervention acceptable and were willing to participate in a future study. After 10 weeks, 65% remained not well controlled (ACQ-5 > 1) and would have required the 'extended' assessment. Participants had a mean (SD) 4.8 (2.3) of 13 traits assessed. ACQ-5 improved during the study by -1.0 (0.3 to 1.8) units, and post-bronchodilator airflow limitation reduced from 59% of participants to 35%. 12/29 (41%) participants received continuous oral corticosteroids at some point during the study.
CONCLUSION: Protocolised treatable trait management was acceptable to participants, associated with significant clinical benefit, and a full RCT appears feasible. Targeting type-2 inflammation and airflow obstruction was insufficient to control asthma in the majority of patients, despite marked systemic corticosteroid exposure.
TRIAL REGISTRATION: ACTRN12620000935932.
METHODS: Ten week single-group cohort study. Participants had a doctor's diagnosis of asthma, Asthma Control Questionnaire-5 (ACQ-5) score > 1, and ≥ 1 exacerbation in the last year.
INTERVENTION: biomarker-guided asthma medication according to a protocolised algorithm, targeting traits of type-2 inflammation and airflow obstruction. Feasibility outcomes: recruitment rates, acceptability of intervention, willingness to enrol in an RCT, need for 'extended' trait assessment after 10 weeks, and estimation of trait prevalence.
RESULTS: Recruitment ceased with 29/50 participants after 14 months due to difficulties associated with COVID-19. Recruitment rate: 29/118 (25%) of those invited to participate (95% CI 17 to 33). 24/26 (92%) participants found the intervention acceptable and were willing to participate in a future study. After 10 weeks, 65% remained not well controlled (ACQ-5 > 1) and would have required the 'extended' assessment. Participants had a mean (SD) 4.8 (2.3) of 13 traits assessed. ACQ-5 improved during the study by -1.0 (0.3 to 1.8) units, and post-bronchodilator airflow limitation reduced from 59% of participants to 35%. 12/29 (41%) participants received continuous oral corticosteroids at some point during the study.
CONCLUSION: Protocolised treatable trait management was acceptable to participants, associated with significant clinical benefit, and a full RCT appears feasible. Targeting type-2 inflammation and airflow obstruction was insufficient to control asthma in the majority of patients, despite marked systemic corticosteroid exposure.
TRIAL REGISTRATION: ACTRN12620000935932.