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Enrolling by Invitation

NCT Number: NCT06811740

Treatable Traits of Severe Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized cluster management

Procedure

Individualized cluster management for treatable traits

Routine asthma treatment

Procedure

Routine asthma treatment according to current guidelines

Primary outcomes

  1. Asthma Quality of life score (AQLQ)

    Time frame: 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 outcomes

  1. Asthma Control Questionnaire score (ACQ-5)

    Time frame: 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.

  2. Forced Expiratory Volume in 1 second(FEV1)

    Time frame: 6 months

    Changes in lung function Forced Expiratory Volume in 1 second(FEV1) from baseline

  3. Exacerbation

    Time frame: 6 months

    the number of acute asthma attacks within 6 months

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Capital Medical University
  • Peking University Third Hospital

Registry information

Official study title

The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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