Clinical trial NCT03046433: Children-Adult Asthma Cohort Study in China
Official title: Children-Adult Asthma Cohort Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma in Children
Keywords: children
asthma
China
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
name: Capital Institute of Pediatrics, China
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: China-Japan Friendship Hospital
name: Ruijin Hospital
name: Xiangya Hospital of Central South University
name: Beijing Chao Yang Hospital
First posted: 2017-02-08
Enrollment: 4000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline
timeFrame: 60 months
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire with Standardized Activities
timeFrame: 3 months
measure: Asthma Control Questionnaire
timeFrame: 3 months
measure: Frequencies of acute attack of asthma in children
timeFrame: 60 months
measure: Complications of children with pediatric asthma
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.
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. No abstract available. Chinese.