Children-Adult Asthma Cohort Study in China
1 other identifier
observational
4,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 9, 2017
May 1, 2017
4.8 years
January 25, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline
60 months
Secondary Outcomes (4)
Asthma Quality of Life Questionnaire with Standardized Activities
3 months
Asthma Control Questionnaire
3 months
Frequencies of acute attack of asthma in children
60 months
Complications of children with pediatric asthma
60 months
Eligibility Criteria
Children who was confirmed diagnosis as asthma or cough variant asthma (CVA) at the certain hospitals (sponsor and collaborators)
You may qualify if:
- Age: More than or equal to 6 years old
- Fulfilling the diagnosis criteria of asthma or cough variant asthma (CVA) based on the guideline of China.
- The patients cooperated very well with the doctors to perform lung function test.
- Asthma is defined as fulfilling followings 1-4 or 4 and 5:
- History of variable respiratory symptoms: wheezing, shortness of breath, chest tightness, and coughing. Symptoms are often worse at night or upon awakening, and often triggered by exercise, laughter, allergens, or cold air, viral infections.
- At onset, scattered wheeze in the lungs is heard with prolonged expiratory time.
- The above symptoms and signs were efficient for anti-asthma, or alleviates voluntarily.
- Exclusive of other diseases with wheezing, shortness of breath, chest tightness, and coughing.
- If the manifestation is non-typical, fulfilling one of the followings:
- Documented airflow limitation：
- Positive BD reversibility test: Increase in FEV1 of \>12% from baseline, 15 minutes after inhalation of 200-400 μg albuterol;
- Significantly increased in lung function after anti-inflammatory treatment;
- Increase in FEV1 of \>12%, after 4 to 8 weeks of treatment with inhaled corticosteroids and (or) anti-leukotrienes.
- Positive bronchial challenge test;
- Excessive variability in twice-daily PEF over 2 weeks: Average daily diurnal PEF variability \>13%.
- +7 more criteria
You may not qualify if:
- Subject will be excluded if she or he has one of the following:
- congenital heart disease;
- heart failure;
- liver failure or renal insufficiency;
- kidney disease;
- connective tissue disease;
- immunodeficiency;
- tumor;
- a history of hypertension or diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Children's Hospitallead
- Shengjing Hospitalcollaborator
- Capital Institute of Pediatrics, Chinacollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- China-Japan Friendship Hospitalcollaborator
- Ruijin Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Beijing Chao Yang Hospitalcollaborator
Related Publications (4)
Pedersen SE, Hurd SS, Lemanske RF Jr, Becker A, Zar HJ, Sly PD, Soto-Quiroz M, Wong G, Bateman ED; Global Initiative for Asthma. Global strategy for the diagnosis and management of asthma in children 5 years and younger. Pediatr Pulmonol. 2011 Jan;46(1):1-17. doi: 10.1002/ppul.21321. Epub 2010 Oct 20.
PMID: 20963782BACKGROUNDBoulet LP, FitzGerald JM, Reddel HK. The revised 2014 GINA strategy report: opportunities for change. Curr Opin Pulm Med. 2015 Jan;21(1):1-7. doi: 10.1097/MCP.0000000000000125.
PMID: 25405667BACKGROUNDNational Cooperative Group on Childhood Asthma; Institute of Environmental Health and Related Product Safety, Chinese Center for Disease Control and Prevention; Chinese Center for Disease Control and Prevention. [Third nationwide survey of childhood asthma in urban areas of China]. Zhonghua Er Ke Za Zhi. 2013 Oct;51(10):729-35. Chinese.
PMID: 24406223BACKGROUNDSubspecialty Group of Respiratory Diseases, Society of Pediatrics, Chinese Medical Association; Editorial Board, Chinese Journal of Pediatrics. [Guideline for the diagnosis and optimal management of asthma in children(2016)]. Zhonghua Er Ke Za Zhi. 2016 Mar;54(3):167-81. doi: 10.3760/cma.j.issn.0578-1310.2016.03.003. No abstract available. Chinese.
PMID: 26957061BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Kunling Shen, Study Principal Investigator
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of China National Clinical Research Center for Respiratory Diseases
Study Record Dates
First Submitted
January 25, 2017
First Posted
February 8, 2017
Study Start
June 1, 2017
Primary Completion
March 1, 2022
Study Completion
December 1, 2022
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share