Asthma
Conditions
Interventions
Biological Therapy Group :Biological Therapy
Non-biological Therapy Group :Conventional therapy
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, baseline visit age>=12 years old. 2. Diagnosed with asthma according to the Global Asthma Initiative (GINA) and/or Chinese standards (i.e. guidelines for the prevention and treatment of bronchial asthma). 3. Meet one of the following criteria (A, B) A. In the past three months, the use of medium to high doses of ICS combined with control drugs has not been controlled (as determined by the doctor), and asthma has not been controlled, covering one or more of the following: (1) Poor symptom control: ACQ-5>=1.5; (2) Acute attacks in the past year: at least one asthma acute attack requiring emergency or hospitalization within the 12 months prior to indexing; (3) FEV1=12 but<18 years old) must obtain written informed consent from the subjects and their legal guardians.
Exclusion criteria
Exclusion criteria: 1. Received biologic therapy within 6 months prior to the baseline visit. 2. The researchers believe that any diseases that may interfere with the participants' participation in this study, such as short life expectancy, severe cognitive impairment, or other expected comorbidities that may affect the participants' ability to fully complete the visit and evaluation arrangements. During the 4-week screening visit, hospitalization or treatment with high-dose oral corticosteroids (>30 mg/day prednisolone) is required for unstable asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function;Fractional exhaled nitric oxide;Venous blood analysis;Cytological classification of induced sputum;Immunoglobulin E(IgE); | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-item Asthma Control Questionnaire(ACQ-5);Mini Asthma Quality of Life Questionnaire(Mini-AQLQ);Pediatric Asthma Quality of Life Questionnaire(PAQLQ);Visual Analogue Scale for Allergic Rhinitis(AR-VAS);Sino-Nasal Outcome Test-22(SNOT-22);Healthcare Resource Utilization Questionnaire(HRUQ); | — |
Countries
China
Contacts
Public ContactRuchong Chen
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed