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Children-Adult Asthma Cohort Study in China

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ClinicalTrials.gov Identifier: NCT03046433
Recruitment Status : Not yet recruiting
First Posted : February 8, 2017
Last Update Posted : May 9, 2017
Sponsor:
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
Information provided by (Responsible Party):
Kunling Shen, Beijing Children's Hospital

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.

Condition or disease
Asthma in Children

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.


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Children-Adult Asthma Cohort Study in China
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Long-term changes on lung function of Chinese children with asthma when treated according to GINA guideline [ Time Frame: 60 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 60 months ]
    Times of acute asthmatic attack will be recorded every year from baseline to 60 months, assessed by questionnaire.

  4. Complications of children with pediatric asthma [ Time Frame: 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046433


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

Sponsors and Collaborators
Beijing Children's Hospital
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

Publications:
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Responsible Party: Kunling Shen, Chief of China National Clinical Research Center for Respiratory Diseases, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT03046433     History of Changes
Other Study ID Numbers: BCHlung008
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kunling Shen, Beijing Children's Hospital:
children
asthma
China

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases