Status:
RECRUITING
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
Lead Sponsor:
Beijing Chao Yang Hospital
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07136025
Start Date
February 1 2025
End Date
January 31 2029
Last Update
August 22 2025
Active Locations (10)
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1
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
2
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
4
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China