NCT07136025 The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
| NCT ID | NCT07136025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Chao Yang Hospital |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-02-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis. * 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 * Anti-tuberculosis treatment is ongoing * Women who are pregnant and lactating * 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 * QTc interval prolongation \>480ms * Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07136025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07136025 currently recruiting?
Yes, NCT07136025 is actively recruiting participants. Contact the research team at kewuhuang@126.com for enrollment information.
Where is the NCT07136025 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Guangzhou, China and 6 additional locations.
Who is sponsoring the NCT07136025 clinical trial?
NCT07136025 is sponsored by Beijing Chao Yang Hospital. The trial plans to enroll 200 participants.
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