Allergic asthma
Conditions
Interventions
Intervention groups (Group A, Group B and Group C):Group A Intervention:
Patients received specific immunotherapy (AIT) using a single-dose rapid protocol for 52 weeks, with an overall observation p
follow-up after 52 weeks was conducted based on patient condition. If acute asthma exacerbation occurred during treatment, AIT was suspended and patients were switched to Group B for omalizumab therap
Initiation phase (combination therapy): AIT single-dose rapid protocol combined with omalizumab, typically for 7 weeks, followed by maintenance therapy after assessment at week 16 of AIT
Maintenance phase (AIT phase): Specific immunotherapy, with evaluation of whether to continue omalizumab combination
overall observation lasted 52 weeks, followed by follow-up after 52 weeks.
Group C Intervention:
Patients received combination therapy of omalizumab and AIT, following this protocol:
Pre-treatmen
Initiation phase (combination therapy): AIT standard-dose protocol combined with omalizumab, typically for 14 weeks, followed by maintenance therapy after assessment at week 16 of AIT
overall observation lasted 52 weeks, followed by follow-up after 52 weeks.
Sponsors
Fudan University Affiliated Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants who meet all of the following criteria are eligible to enter this study: 1. Children, adolescents, and adults aged 6+; 2. According to the "Diagnosis and Treatment Guidelines for Allergic Asthma in China (2019, First Edition)", asthma patients diagnosed with dust mite allergy; 3. The number of acute asthma attacks in the past year is = 60%; 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not allowed to enter this study: 1. Within 4 or 5 half-lives prior to signing informed consent, have used anti-IgE drugs, other biological agents targeting the IgE or Th2 pathway (such as omalizumab and its biosimilars, anti-IL-4/5/13 monoclonal antibodies), etc; 2. Use systemic immunosuppressive agents (such as methotrexate, cyclosporine, cyclophosphamide, tacrolimus, Tripterygium wilfordii Hook. f.); 3. Allergies to omalizumab, therapeutic drug excipients, or other biosimilars, or a history of severe drug allergies or anaphylactic shock; 4. Patients with total IgE=1500 U/ml or body weight=150 kg; 5. Elevated IgE levels due to reasons other than allergens; 6. When the patient is in the acute phase of asthma attack or acute exacerbation of asthma; 7. Screening for acute active infections that require treatment, including but not limited to pulmonary infections and tuberculosis; 8. There are individuals at high risk of worm infection; 9. The following clinically significant unstable diseases exist: (1) High risk of severe ventricular arrhythmias, such as significant left ventricular dysfunction, NYHA functional class III/IV, family history of long QT syndrome, or known family history of apical torsion ventricular tachycardia; (2) Have experienced a myocardial infarction within the past 6 months prior to screening. History of high-risk coronary heart disease such as unstable angina and acute coronary syndrome; (3) Poorly controlled hypertension [diagnosed as grade 2 or above, with risk factors stratified into high-risk groups, still experiencing systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg when taking one or two antihypertensive drugs]; 10. During the screening period, significant cardiovascular, neurological, psychiatric, metabolic, liver, or other abnormalities of clinical significance were identified that may affect the interpretation of research results and/or the safety of participants, including but not limited to: (1) Severe liver dysfunction [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=5 times the upper limit of normal value, or total bilirubin >=3 times the upper limit of normal value]; Severe renal dysfunction [elevated serum creatinine >3 times the upper limit of normal]; (2) Clinically significant electrocardiographic abnormalities: In the absence of a pacemaker, the 12-lead electrocardiogram shows grade II or III atrioventricular block; QTc interval >=480 ms; rapid arrhythmia requiring clinical management; 11. Patients with poor compliance find it difficult to persist in treatment for a long time due to various reasons; 12. The researchers believe that the subjects have other circumstances that are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of systemic and local adverse reactions, assessment of severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma Control Test (ACT) score;Symptom control of rhinitis: Daily nasal symptom severity score (TNSS); First second forced expiratory volume (FEV1);Percentage of blood eosinophils;The proportion of patients who successfully received AIT treatment;;Dose and frequency of inhaled corticosteroids (ICS) or oral corticosteroids (OCS) or nasal corticosteroids or antihistamines used; Record the duration and proportion of drug discontinuation;; Asthma Quality of Life Questionnaire score (Mini AQLQ),; Asthma daytime and nighttime symptom scores; Asthma and Rhinitis Visual Analog Scale (VAS);Exhaled nitric oxide (FeNO);Total serum IgE;Serum dust mite specific IgE;Serum dust mite specific IgG4; | — |
Countries
China
Contacts
Public ContactJin Meiling
Fudan University Affiliated Zhongshan Hospital
Outcome results
None listed