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Randomized Controlled Trial
. 2025 Jun;30(6):480-492.
doi: 10.1111/resp.70016. Epub 2025 Mar 12.

Treatable Trait Guided Asthma Management: A Feasibility Study

James Fingleton  1 , Rob McLachlan  1   2 , Jenny Sparks  2 , Richard Beasley  2 , Alvar Agustí  3 , Peter G Gibson  4 , Ian D Pavord  5 , Jo Hardy  2 , Mark Weatherall  6 , Allie Eathorne  2 , Vanessa M McDonald  4 ; Treatable Traits Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Treatable Trait Guided Asthma Management: A Feasibility Study

James Fingleton et al. Respirology. 2025 Jun.

Abstract

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.

Keywords: asthma; clinical trial; inflammometry; phenotypes; treatable trait.

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Conflict of interest statement

J.F. reports personal fees and non‐financial support from AstraZeneca and GSK outside the submitted work. R.B. reports research funding from AstraZeneca, Genentech, Teva, and Cure Kids NZ, and personal fees from AstraZeneca, Teva, Avillion, and Cipla; outside the submitted work. A.A. reports research funding from AstraZeneca, GSK, and the Menarini Foundation, and personal fees from AstraZeneca, Chiesi, GSK, the Menarini Foundation, MSD, Sanofi, and Zambon; outside the submitted work. P.G.G. reports research funding from GSK and personal fees from AstraZeneca, GSK, Novartis, and Sanofi; outside the submitted work. I.D.P. reports research funding, personal fees, and non‐financial support from Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Roche‐Genentech, GSK, Knopp, Merck, Novartis, Sanofi‐Regeneron, and Teva; outside the submitted work; and royalties related to the Leicester Cough Questionnaire from Bayer, Ismed, and Merck outside the submitted work. J.H. reports non‐financial support from AstraZeneca outside the submitted work. V.M.M. reports personal fees and non‐financial support from GSK, Boehringer Ingelheim, and the Menarini Foundation outside the submitted work. A.E., J.S., M.W., and R.M. declare no conflicts of interest. R.B. and V.M.M. are Editorial Board members of Respirology and co‐authors of this article. They were excluded from all editorial decision‐making related to the acceptance of this article for publication.

Figures

FIGURE 1
FIGURE 1
Study schematic.
FIGURE 2
FIGURE 2
Participant flow through the study.
FIGURE 3
FIGURE 3
FEV1 and PROM change during the study. The four sub‐panels show changes in FEV1 in litres as well as ACQ, AQLQ, and SGRQ scores during the course of the study.
FIGURE 4
FIGURE 4
Corticosteroid treatment level. Figure shows corticosteroid treatment level during the study. Details of corticosteroid treatment levels are given in Table 1d.
FIGURE 5
FIGURE 5
Composite biomarker status.
See this image and copyright information in PMC

References

    1. Fingleton J., Hardy J., and Beasley R., “Treatable Traits of Chronic Airways Disease,” Current Opinion in Pulmonary Medicine 24, no. 1 (2018): 24–31, 10.1097/MCP.0000000000000445. - DOI - PubMed
    1. Agusti A., Bel E., Thomas M., et al., “Treatable Traits: Toward Precision Medicine of Chronic Airway Diseases,” European Respiratory Journal 47 (2016): 410–419. - PubMed
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    1. McDonald V. M., Fingleton J., Agusti A., et al., “Treatable Traits: A New Paradigm for 21st Century Management of Chronic Airway Diseases: Treatable Traits Down Under International Workshop Report,” European Respiratory Journal 53, no. 5 (2019): 1802058, 10.1183/13993003.02058-2018. - DOI - PubMed
    1. Clark V. L., Gibson P. G., Genn G., Hiles S. A., Pavord I. D., and McDonald V. M., “Multidimensional Assessment of Severe Asthma: A Systematic Review and Meta‐Analysis,” Respirology 22 (2017): 1262–1275. - PubMed

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