Treatable Traits of Severe Asthma

Not Applicable

• Conditions: Asthma

• Registration Number: NCT06811740
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-04
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-06
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma Quality of life score (AQLQ)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire score (ACQ-5)	6 months	Changes in Asthma Control Questionnaire score (ACQ-5) from baseline at 6 months；ACQ-5 (Asthma Control Questionnaire) is a scoring scale for assessing asthma control. It consists of 5 simple questions to assess a patient's level of asthma control in the past week. Each problem was scored on a scale of 0-6 according to its severity. The average score of the five problems \<0.75 was asthma control, 0.75 \~ 1.5 was asthma partial control, and \>1.5 was asthma uncontrolled.
Forced Expiratory Volume in 1 second（FEV1）	6 months	Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline
Exacerbation	6 months	the number of acute asthma attacks within 6 months

Trial Locations

Locations (3)

Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Haidian, China

Beijing Luhe Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Tongzhou, China