Children-Adult Asthma Cohort Study in China

Asthma in Children Clinical Trial

Official title:

Children-Adult Asthma Cohort Study in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03046433
• Other study ID #: BCHlung008
• Status: Not yet recruiting
• Phase: N/A
• First received: January 25, 2017
• Last updated: May 8, 2017
• Start date: June 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2017
• Source: Beijing Children's Hospital
• Contact: Baoping Xu, MD,PhD
• Phone: 861059616308
• Email: xubaopingbch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Biological samples will be collected when recruiting and finishing follow-up.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Children's Hospital	Beijing Chao Yang Hospital, Capital Institute of Pediatrics, China, China-Japan Friendship Hospital, Ruijin Hospital, Shengjing Hospital, Xiangya Hospital of Central South University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline		60 months
Secondary	Asthma Quality of Life Questionnaire with Standardized Activities		3 months
Secondary	Asthma Control Questionnaire		3 months
Secondary	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.	60 months
Secondary	Complications of children with pediatric asthma		60 months