Clinical trial NCT06811740: Treatable Traits of Severe Asthma
Official title: The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asthma
Keywords: treatable traits
asthma
severe
AQLQ
ACQ
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Peking University Third Hospital
First posted: 2025-02-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe or uncontrolled asthma is a complex heterogeneous disease, in which patients may exhibit different types of airway inflammation and often accompany multiple comorbidities and risk factors. Identifying potential modifiable factors that influence prognosis, i.e., "treatable traits," and targeting these traits for individualized, bundled management of patients may help improve the quality of life of asthma patients and enhance asthma control levels. This project aims to investigate the distribution of treatable traits in uncontrolled asthma patients in Beijing by conducting pulmonary function tests, exhaled nitric oxide tests, blood tests, allergen IgE tests, and chest CT scans, as well as detailed questionnaires, on patients from three tertiary hospitals in Beijing. The project will also assess the impact of treatable traits on the quality of life or asthma control levels of uncontrolled asthma patients in a multidimensional manner. Furthermore, the project will select severe asthma patients and establish an individualized, bundled management model based on the treatable traits of severe asthma, through multidisciplinary consultations and shared decision-making with patients. A randomized, parallel-group clinical trial will then be conducted for six months to confirm whether this management model is superior to conventional management in improving the quality of life or asthma control levels of severe asthma patients. The implementation of this project will establish a new model of individualized management for severe asthma based on treatable traits, thereby improving the management level of severe asthma.


Eligibility criteria: Inclusion Criteria

* Must be at least 18 years old and have resided in Beijing for at least 6 months.
* Must meet the diagnostic criteria for asthma as outlined in the 2023 GINA guidelines, have written evidence of variable airflow limitation, and have been receiving asthma treatment for at least 6 months.
* Must meet one or both of the following criteria as defined in the 2023 GINA guidelines for uncontrolled asthma: poor symptom control (defined as an Asthma Control Questionnaire (ACQ-5) score of 0.75 or higher); frequent acute exacerbations (≥2 per year) requiring oral corticosteroids, or severe acute exacerbations (≥1 per year) requiring emergency or hospitalization.
* Willing to undergo a multidisciplinary, multi-dimensional evaluation and sign an informed consent form.
* Must meet the criteria for severe asthma as outlined in the 2023 GINA guidelines

Exclusion Criteria

* Use macrolides within 4 weeks of the screening period
* Use anti-IgE, anti-IL-5, or anti-IL-5R therapy within 4 weeks of the screening period
* Use inhaled ICS + LABA + long-acting muscarinic antagonist (LAMA) within 4 weeks of the screening period
* Be allergic to macrolides
* Have a QTc interval prolongation of \>480ms
* Take a medication that interacts with azithromycin to prolong the QTc interval or cause existing ECG abnormalities, which may lead to arrhythmias.

Primary outcomes:
measure: Asthma Quality of life score (AQLQ)
timeFrame: 6 months
Secondary outcomes:
measure: Asthma Control Questionnaire score (ACQ-5)
timeFrame: 6 months
measure: Forced Expiratory Volume in 1 second（FEV1）
timeFrame: 6 months
measure: Exacerbation
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian
city: Beijing
country: China
facility: Beijing Luhe Hospital affiliated to Capital Medical University
state: Tongzhou
Study officials:
References:
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citation: McDonald VM, Fingleton J, Agusti A, Hiles SA, Clark VL, Holland AE, Marks GB, Bardin PP, Beasley R, Pavord ID, Wark PAB, Gibson PG; participants of the Treatable Traits Down Under International Workshop; Treatable Traits Down Under International Workshop participants:. Treatable traits: a new paradigm for 21st century management of chronic airway diseases: Treatable Traits Down Under International Workshop report. Eur Respir J. 2019 May 9;53(5):1802058. doi: 10.1183/13993003.02058-2018. Print 2019 May.
citation: Wu WW, Zhang X, Li M, Liu Y, Chen ZH, Xie M, Zhao SZ, Wang G, Zhang HP, Wang T, Qin L, Wang L, Oliver BG, Wan HJ, Zhang J, McDonald VM, Marks GB, Li WM, Birring SS, Wang G, Gibson PG. Treatable Traits in Elderly Asthmatics from the Australasian Severe Asthma Network: A Prospective Cohort Study. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2770-2782. doi: 10.1016/j.jaip.2021.03.042. Epub 2021 Apr 5.
citation: McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.
citation: McDonald VM, Clark VL, Cordova-Rivera L, Wark PAB, Baines KJ, Gibson PG. Targeting treatable traits in severe asthma: a randomised controlled trial. Eur Respir J. 2020 Mar 5;55(3):1901509. doi: 10.1183/13993003.01509-2019. Print 2020 Mar.