asthma
Conditions
Interventions
rescue intervention strategy, RIS:If the air quality index (AQI) issued by the monitoring station closest to the participant’s residence exceeds 150 between 20:00 of the previous day and 7:00 of the c
control group:The baseline asthma treatment will be continued, and budesonide/formoterol or SABA as needed for symptom relief are allowed. Each patients will be assessed every 3 months, and step up or
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Female or male aged 18 to 75 years old (including the threshold value) 2)Established diagnosis of asthma by physicians according to Guidelines for asthma prevention and management in China (2020 edition). 3)Subjects are documented to receive treatment with a low-to-medium dose ICS (200 to 800 ? budesonide per day or equivalents) in combination with a LABA for at least 30 days prior to baseline visit. 4)Non-smokers or ex-smokers with a pack history =10 pack years and quitting smoking for at least 6 months. 5)Able to engaged in daily activity. 6) Able to use of a smartphone; 7) Consent to enter the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Subjects with significant other respiratory diseases other than asthma in particular chronic obstructive pulmonary disease, lung cancer, pulmonary embolism, tuberculosis, bronchiectasis, interstitial lung disease, pulmonary hypertension. 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) regime). 4)Subjects with any contraindication to budesonide/formoterol. 5)The subject has an asthma exacerbation within 30 days before the baseline visit. 6)Subjects with respiratory infections that affect asthma control within 2 weeks prior to the baseline visit. 7)The subject is receiving or have ever received treatment with biological agents within 4 months prior to the baseline visit. 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)The subject has 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)The subject has previous or current occupational exposure to dust or hazardous gases. 16)Alcoholics, drug addicts, or substance abusers. 17)Subjects who are participating in other clinical trials. 18)Those who cannot be followed up for a long time or have poor compliance. 19)Female subject who is pregnant or lactating or is going to become pregnant during the study period. 20)The investigator considers that the subject is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the number of asthma exacerbations per patient year; | — |
Secondary
| Measure | Time frame |
|---|---|
| the number of severe asthma exacerbations per patient year;the time to first asthma exacerbation;the time to first severe asthma exacerbation;the percentage of patients with at least one asthma exacerbation;the percentage of patients with at least one severe asthma exacerbation;the percentage of symptom-flee days;the percentage of days free of rescue medication;the changes of FEV1 and FVC from baseline;the changes of mini-AQLQ from baseline; | — |
Countries
China
Contacts
Public ContactYan Hu
Peking University First Hospital
Outcome results
None listed