NCT06811740Enrolling by invitation
Treatable Traits of Severe Asthma
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 5 Feb 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- Asthma
- NCT number
- NCT06811740
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jan 2024 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use anti-IgE, anti-IL-5, or anti-IL-5R therapy within 4 weeks of the screening period
Other illness
- Be allergic to macrolides
Lab values
- 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.
Other
- Use macrolides within 4 weeks of the screening period
- Use inhaled ICS + LABA + long-acting muscarinic antagonist (LAMA) within 4 weeks of the screening period
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Luhe Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.