Treatable Traits of Severe Asthma

NCT06811740 | Enrolling By Invitation DMC

• 1 other identifier: 2024-KE-338
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

treatable traits; asthma; severe; AQLQ; ACQ

Outcome Measures

Primary Outcomes (1)

• Asthma Quality of life score (AQLQ)

  Changes in asthma Quality of life score (AQLQ) from baseline at 6 months；Asthma Quality of Life questionnaire (AQLQ) is a scoring scale to evaluate the quality of life of patients with asthma, evaluating the level of asthma control in the past 2 weeks. The AQLQ consisted of 32 questions, which were divided into four sub-areas: symptoms (12 questions), activity limitation (11 questions), emotional function (5 questions) and environmental stimulation (4 questions). Each question was scored on a scale of 1 to 7 points according to its severity, with 1 indicating complete limitation and 7 indicating no limitation at all. The total score is calculated as the average of all questions and the average of each partition.

  6 months

Secondary Outcomes (3)

• Asthma Control Questionnaire score (ACQ-5)

  6 months

• Forced Expiratory Volume in 1 second（FEV1）

  6 months

• Exacerbation

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Implement individualized cluster management based on treatable traits

Procedure: Individualized cluster management

Placebo

OTHER

Routine asthma treatment according to current guidelines

Procedure: Routine asthma treatment

Interventions

Individualized cluster management PROCEDURE

Individualized cluster management for treatable traits

Intervention group

Routine asthma treatment PROCEDURE

Routine asthma treatment according to current guidelines

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Capital Medical University: collaborator
• Peking University Third Hospital: collaborator

Study Sites (3)

Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Peking University Third Hospital

Beijing, Haidian, 100191, China

Location

Beijing Luhe Hospital affiliated to Capital Medical University

Beijing, Tongzhou, 101199, China

Location

Related Publications (6)

• Rose L, Istanboulian L, Carriere L, Thomas A, Lee HB, Rezaie S, Shafai R, Fraser I. Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701567. doi: 10.1183/13993003.01567-2017. Print 2018 Jan.

  PMID: 29326330 BACKGROUND

• Ko FW, Cheung NK, Rainer TH, Lum C, Wong I, Hui DS. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2017 Feb;72(2):122-128. doi: 10.1136/thoraxjnl-2016-208396. Epub 2016 Jul 28.

  PMID: 27471050 BACKGROUND

• 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.

  PMID: 30846468 BACKGROUND

• 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.

  PMID: 33831621 BACKGROUND

• 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.

  PMID: 30230137 BACKGROUND

• 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.

  PMID: 31806719 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2025

Record last verified: 2024-04

Locations

CN (3)