Viewing Study NCT03046433


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Study NCT ID: NCT03046433
Status: UNKNOWN
Last Update Posted: 2017-05-09
First Post: 2017-01-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Children-Adult Asthma Cohort Study in China
Sponsor: Beijing Children's Hospital
Organization:

Study Overview

Official Title: Children-Adult Asthma Cohort Study in China
Status: UNKNOWN
Status Verified Date: 2017-05
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is a multicenter and prospective cohort study of children diagnosed with asthma. Clinical symptoms and signs, quality of life, blood test, and lung function were detected every three months. FeNO detection, chest imaging, and induced sputum smear were detected when necessary. Biological samples will be collected when recruiting and finishing follow-up.
Detailed Description: Asthma is one of the most common chronic diseases all over the world. GINA (Global Initiative for Asthma) reported that nearly 300 million were diagnosed with asthma, while in China even reach to 30 million. In recent years, the prevalence of pediatric asthma and severe cases in China has increased considerably. In 2013, the third national survey carried out in 43 cities in 27 provinces and found that asthma prevalence among children aged 0-14 years old reached to 3.02%, with the highest prevalence in Shanghai (7.57%), while in year of 2000, the rat was 1.09%. However, the research about mechanism, risk factors, individualized prevention and treatment strategy of asthma in China is still not perfect and there is no basic data and multicenter cohort study. Therefore, this multicenter cohort study is conducted, in order to set up a complete database, biobank and long term follow up of Chinese children, and establish foundations for basic research and precise medicine.

Pediatric patients more than or equal to 6 years old diagnosed with asthma will be recruited in this study. After evaluating the baseline, the patients were followed up. Visiting doctors and filling in a questionnaire for every three months, the clinical symptoms, physical examination, will be detected. Chest X ray, blood tests, lung function test and FeNO test would be done when necessary. And, biological samples of blood, urine and throat swab will be collected when recruiting and finishing follow-up. The trial will be completed in 60 months, with 4000 subjects recruited from 8 hospitals.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: