NCT07136025Recruiting
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- Asthma
- NCT number
- NCT07136025
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Feb 2025 to the primary completion date, 31 Jan 2029
- 10 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
- Chest surgery or abdominal surgery in the past 3 months
- Eye surgery had been performed within the past 3 months
- Myocardial infarction within the previous 3 months
- Macrolide use within 4 weeks before the screening period
- Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period
- Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period 4. Allergy to macrolides
Other illness
- The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
- Anti-tuberculosis treatment is ongoing
Lab values
- QTc interval prolongation \>480ms
- Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
Other
- Women who are pregnant and lactating
Who the study is looking for
- Age ≥18 years, and \<80 years with a definite diagnosis of asthma for at least 6 months
- Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
- They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
- Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tiantan Hospital Affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.