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Asthma in ChildrenNCT03046433

Children-Adult Asthma Cohort Study in China

An observational study of Asthma in Children, run by Beijing Children's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Asthma in Children
How many people
4,000 participants
Where
No sites listed yet
Study dates
Jun 2017to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • 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;
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  • immunodeficiency;
  • tumor;
  • a history of hypertension or diabetes mellitus.

Trial locations and contacts

No sites are listed yet.

Baoping Xu, MD,PhD contact

861059616308

xubaopingbch@163.com

Kunling Shen, Study Principal Investigator contact

About this study

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.

Keywords
children, asthma, China
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 60 months

Secondary outcomes (4)

  1. Asthma Quality of Life Questionnaire with Standardized Activities

    Measured: 3 months

  2. Asthma Control Questionnaire

    Measured: 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.

    Measured: 60 months

  4. Complications of children with pediatric asthma

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2017 (estimated)
  2. Study startJun 2017 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03046433
Sponsor's protocol ID
BCHlung008
Status last verified
May 2017
First submitted
25 Jan 2017
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma in Children, run by Beijing Children's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Baoping Xu, MD,PhD (861059616308, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03046433, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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