Asthma
Conditions
Interventions
Intervention Group:Digital Asthma Management Platform Implementation:A digital management platform was deployed for asthma patient care, facilitating health education, clinician-patient communication,
Control Group:None
Biological Agent Group:The physician assessed that the asthmatic patient had an indication for biological agent use, and the patient consented to its use after being informed of their condition.
Control group:Standard asthma treatment, including combination therapy of basic inhaled corticosteroids and controller medications
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Adult: (1) Patients must be at least 16 years old at the time of signing the informed consent form; (2) Physician-confirmed asthma diagnosis with documented evidence of reversible airflow limitation (e.g., bronchodilator reversibility test or equivalent objective verification); (3) Capacity to operate electronic devices (by participant or guardian) and willingness to use the designated digital management platform; (4) Written informed consent signed and dated by the participant and/or legally authorized representative prior to any study procedures, with commitment to complete follow-up and data submission. Children: (1) Patients aged 0-16 years old; (2) Asthma diagnosis meets the diagnostic criteria of the "Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children"; (3) Guardians possess the ability to use electronic devices and agree to use the designated electronic management platform; (4) Guardians and children sign the informed consent form, committing to complete follow-ups and data submission. Prospective Study: (1) Male or female, aged >=12 years at the baseline visit. (2) Diagnosed with asthma according to the Global Initiative for Asthma (GINA) and/or Chinese guidelines (i.e., the Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma). (3) Meets one of the following criteria (A or B): A. In the past 3 months, asthma remains uncontrolled despite the use of medium-to-high dose ICS combined with controller medications (as determined by the physician). Uncontrolled asthma is defined as meeting one or more of the following criteria: 1) Poor symptom control: ACQ-5 = 1.5. 2) History of exacerbation in the past year: at least one asthma exacerbation requiring emergency department visit or hospitalization within the 12 months prior to the index date. 3) Airflow limitation: pre-bronchodilator FEV1 < 80% predicted (with FEV1/FVC below the lower limit of normal). 4) Or, at least two courses of systemic corticosteroids (OCS) for acute exacerbations within the 12 months prior to the index date (each course lasting at least 3 days). B. Within the past 12 months, systemic corticosteroids or other systemic immunosuppressants (at any dose level) have been used for the treatment of severe asthma for approximately 50% or more of the time (primarily not for the treatment of other diseases). (4) Willing and able to provide informed consent and comply with required clinical visits, study procedures, and assessments. (5) Able to understand and complete study-related questionnaires. (6) Voluntarily agrees to participate in the study and provides signed written informed consent.
Exclusion criteria
Exclusion criteria: Adult: (1) Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory diseases excluding asthma; (2) Any clinically significant disorder (e.g., cardiovascular, respiratory [non-asthma], gastrointestinal, hepatic/renal, neurological, musculoskeletal, endocrine/metabolic, malignancy, psychiatric, or major physical impairment) that, in the investigator's judgment, may: - Increase risk to the participant from study involvement, - Interfere with study results interpretation, - Compromise the participant's ability to complete the study; (3) Requirement for systemic/oral corticosteroid therapy for conditions other than asthma; (4) Participation in another interventional clinical trial involving investigational drugs within 3 months prior to enrollment. Children: (1) Presence of other severe diseases, such as congenital pulmonary dysplasia, cystic fibrosis, immunodeficiency, neuromuscular diseases, cerebral palsy, etc.; (2) Lack of a stable internet environment at home or refusal to use electronic device management; (3) Guardians have language or cognitive barriers that prevent them from cooperating with the study procedures. Prospective Study: (1) Received biological agent treatment within 6 months prior to the baseline visit. (2) Any condition that, in the investigator's opinion, may interfere with the subject's participation in the study, such as short life expectancy, severe cognitive impairment, or other comorbidities expected to affect the subject's ability to adequately complete the scheduled visits and assessments. (3) This study will prospectively and consecutively enroll subjects, who will be categorized into either a group initiating biological agent therapy or a non-biological agent group. The decision on whether to initiate biological agent therapy will be based on the physician's assessment of the patient's condition, while the final decision to use such treatment will be made by the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary Function Tests (PFTs);Fractional Exhaled Nitric Oxide (FeNO); | — |
Countries
China
Contacts
Public ContactWenjun Wang
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed