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Status unknownNCT03046433Updated May 9, 2017

Children-Adult Asthma Cohort Study in China

An observational study in Asthma in Children, sponsored by Beijing Children's Hospital. Status unknown. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Beijing Children's Hospital · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma in Children

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Keywords

  • children
  • asthma
  • China
03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 150 across 993 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 52 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children who was confirmed diagnosis as asthma or cough variant asthma (CVA) at the certain hospitals (sponsor and collaborators)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: More than or equal to 6 years old
  2. Fulfilling the diagnosis criteria of asthma or cough variant asthma (CVA) based on the guideline of China.
  3. 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:

  1. 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.
  2. At onset, scattered wheeze in the lungs is heard with prolonged expiratory time.
  3. The above symptoms and signs were efficient for anti-asthma, or alleviates voluntarily.
  4. Exclusive of other diseases with wheezing, shortness of breath, chest tightness, and coughing.

  5. If the manifestation is non-typical, fulfilling one of the followings:

    • Documented airflow limitation：

      1. Positive BD reversibility test: Increase in FEV1 of >12% from baseline, 15 minutes after inhalation of 200-400 μg albuterol;
      2. Significantly increased in lung function after anti-inflammatory treatment;
      3. 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%.

Cough variant asthma (CVA) is defined as fulfilling following:

  1. Cough at least 4 weeks without sputum and wheeze, worsening at night or upon awakening;
  2. No symptoms of infection, or no effect on long term antibiotic treatment;
  3. The symptoms and signs were efficient for anti-asthma treatment;
  4. Exclusive of other diseases causing wheeze;
  5. Positive exercise challenge test and (or) average daily diurnal PEF variability >13%;
  6. Individual or primary, secondary relatives with allergic history, or positive allergen detection.

Exclusion criteria

Exclusion Criteria:

Subject will be excluded if she or he has one of the following:

  1. congenital heart disease;
  2. heart failure;
  3. liver failure or renal insufficiency;
  4. kidney disease;
  5. connective tissue disease;
  6. immunodeficiency;
  7. tumor;
  8. a history of hypertension or diabetes mellitus.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline

    Time frame: 60 months

Secondary outcomes

  1. Asthma Quality of Life Questionnaire with Standardized Activities

    Time frame: 3 months

  2. Asthma Control Questionnaire

    Time frame: 3 months

  3. Frequencies of acute attack of asthma in children

    Times of acute asthmatic attack will be recorded every year from baseline to 60 months, assessed by questionnaire.

    Time frame: 60 months

  4. Complications of children with pediatric asthma

    Time frame: 60 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 20963782 ↗
  • Boulet 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. PubMed 25405667 ↗
  • National 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. PubMed 24406223 ↗
  • Subspecialty 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. PubMed 26957061 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03046433
Lead sponsor
Beijing Children's Hospital
Collaborators
Shengjing Hospital, Capital Institute of Pediatrics, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, China-Japan Friendship Hospital, Ruijin Hospital, Xiangya Hospital of Central South University, Beijing Chao Yang Hospital
Responsible party
Kunling Shen (Chief of China National Clinical Research Center for Respiratory Diseases, Beijing Children's Hospital) — Principal investigator
First posted
Feb 8, 2017
Start date
Jun 2017 (estimated)
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
May 9, 2017

Study contacts

Baoping Xu, MD,PhD
Contact
xubaopingbch@163.com
861059616308
Kunling Shen, Study Principal Investigator
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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