Evaluating asthma biologic use and outcomes in Chinese patients
An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
This study is testing how well asthma medications called biologics work for patients in China and how they affect their health and quality of life over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 32 sites (Beijing and 31 other locations) |
| Trial ID | NCT06605885 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the use of biologics in asthma treatment and the resulting clinical outcomes among patients in China. Approximately 200 patients diagnosed with asthma and prescribed biologics will be enrolled across 50 sites. Participants will undergo clinical assessments and standard medical care, with follow-ups at 24 and 52 weeks to collect data on their health status and quality of life. The study will utilize existing medical records and patient-reported outcomes to evaluate the effectiveness of biologics in managing asthma.
Who should consider this trial
Good fit: Ideal candidates include Chinese individuals of any age with a physician-confirmed diagnosis of asthma who have been prescribed biologics.
Not a fit: Patients who have participated in an interventional study within the last 3 months or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of biologics for asthma treatment in the Chinese population.
How similar studies have performed: While there have been studies on asthma biologics, this specific observational approach in the Chinese population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Chinese, Female or Male 2. Age: no limitation 3. Physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests). 4. Participants or their legal guardians must be able to provide informed consent. 5. Prescription of asthma biologics at enrolment. Exclusion Criteria: 6. Participation in an interventional study within the last 3 months. 7. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
Where this trial is running
Beijing and 31 other locations
- Research Site — Beijing, China (Recruiting)
- Research Site — Changsha, China (Recruiting)
- Research Site — Changsha, China (Withdrawn)
- Research Site — Chengdu, China (Not_yet_recruiting)
- Research Site — Foshan, China (Recruiting)
- Research Site — Fuzhou, China (Recruiting)
- Research Site — Guangzhou, China (Recruiting)
- Research Site — Guangzhou, China (Not_yet_recruiting)
- Research Site — Hangzhou, China (Recruiting)
- Research Site — Hefei, China (Recruiting)
- Research Site — Huhhot, China (Withdrawn)
- Research Site — Jinan, China (Recruiting)
- Research Site — Kunming, China (Recruiting)
- Research Site — Nanchang, China (Recruiting)
- Research Site — Nanjing, China (Recruiting)
- Research Site — Ningbo, China (Recruiting)
- Research Site — Qingdao, China (Not_yet_recruiting)
- Research Site — Quanzhou, China (Recruiting)
- Research Site — Shanghai, China (Recruiting)
- Research Site — Shenyang, China (Not_yet_recruiting)
- Research Site — Shenzhen, China (Recruiting)
- Research Site — Shijiazhuang, China (Recruiting)
- Research Site — Suining, China (Recruiting)
- Research Site — Taiyuan, China (Not_yet_recruiting)
- Research Site — Tianjin, China (Recruiting)
- Research Site — Urumqi, China (Recruiting)
- Research Site — Wenzhou, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
- Research Site — Wuxi, China (Recruiting)
- Research Site — Xi'an, China (Not_yet_recruiting)
- Research Site — Zhengzhou, China (Recruiting)
- Research Site — Zhuhai, China (Recruiting)
Study contacts
- Principal investigator: YuBiao Guo — The Fifth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.