Asthma in Children
Conditions
Interventions
rescue intervention strategy:The hourly AQI data will be recorded according to the data issued by the monitoring station closest to the subject’s residence (data come from China Environmental Monitori
control:The baseline asthma treatment will be continued, and budesonide/formoterol or SABA as needed for symptom relief are allowed. Each patient will be assessed every 3 months, and step up or step d
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Female or male aged 6 to 18 years old (including the threshold value) 2) Established diagnosis of asthma by physicians according to Guideline for the diagnosis and optimal management of asthma in children (2016). 3) Subjects are documented to receive treatment of levels 2 to 4 as recommended by the " Guideline for the diagnosis and optimal management of asthma in children (2016)" for at least 30 days prior to the baseline visit. This includes low to medium-high dose inhaled corticosteroids (equivalent to 200 to 800 µg/day of beclomethasone, including the threshold), or combination therapy with LABA and/or leukotriene receptor antagonists on the basis of low to medium-high dose inhaled corticosteroids. 4) Able to engaged in daily activity.
Exclusion criteria
Exclusion criteria: 1) Subjects with significant other respiratory diseases other than asthma in particular lung cancer, pulmonary embolism, tuberculosis, bronchiectasis, interstitial lung disease, pulmonary hypertension, cystic fibrosis. 2) Significant alternative diagnoses that may mimic asthma, such as allergic bronchopulmonary aspergillosis/mycosis, allergic granulomatosis with polyangitis, idiopathic hypereosinophilic syndrome, dysfunctional breathing, panic attacks, and overt psychosocial problems. 3) The subject has changed asthma medication within 4 weeks prior to the baseline visit (except those using the Symbicort Maintenance and Reliever Therapy (SMART) regimen). 4) The subject has an asthma exacerbation within 30 days before the baseline visit. 5) Subjects with respiratory infections that affect asthma control within 2 weeks prior to the baseline visit. 6) The subject is receiving or have ever received treatment with biological agents within 4 months prior to the baseline visit. 7) The subject previously treated with bronchial thermoplasty. 8) The subject is receiving or have ever received treatment with systemic glucocorticoid within 30 days prior to baseline visit. 9) Subjects complicated with severe or active underlying disorders (e.g. sever mental illness, neurological disease, malignant tumor, severe chronic liver disease, uncontrolled hypertension, uncontrolled diabetes, heart failure, active autoimmune disease, renal failure,etc.). 10) Subjects have received treatment with systemic immunosuppressant/immunomodulatory drugs (e.g.methotrexate, cyclosphorine, etc.) within 6 months prior to baseline visit. 11) Subjects who never perform outdoor activities. 12) Subjects who are expected to move out of the area of their residence during the study period. 13) Subjects who are expected to travel frequently and leave the area of their residence for more than 30 days per year. 14) Subjects who plan to carry out interior renovation during the study period. 15) Alcoholics, drug addicts, or substance abusers. 16) Subjects who are participating in other clinical trials. 17) Those who cannot be followed up for a long time or have poor compliance. 18) The investigator considers that the subject is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annual frequency of acute exacerbations of bronchial asthma.; | — |
Countries
China
Contacts
Public ContactLeping Ye
Peking University First Hospital
Outcome results
None listed