House Dust Mite–Induced Pediatric Asthma
Conditions
Interventions
Group A:Subcutaneous allergen immunotherapy (SCIT)
OM-85 oral administration (single course: one capsule daily for 10 consecutive days per month for 3 months)
Group B:Subcutaneous allergen immunotherapy (SCIT)
OM-85 oral administration (double course: 3 months treatment, followed by a 6-month interval, then another 3 months)
Group C:Subcutaneous allergen immunotherapy (SCIT)
Sponsors
Guangzhou Women and Children’s Medical Center,Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5 to 14 2. Diagnosis of dust mite allergic asthma (sIgE >=0.35 KUA/L) 3. At least one acute asthma attack in the past 12 months 4. Standardized anti-asthma treatment for at least one year 5. Sign informed consent
Exclusion criteria
Exclusion criteria: 1. Uncontrolled moderate to severe asthma (FEV1 < 80% predicted value) 2. Received AIT within the past 5 years 3. Allergic to SCIT or OM-85 4. Use of immunosuppressants/biological agents 5. Severe cardiovascular, mental or autoimmune diseases 6. Those deemed unsuitable by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma Exacerbation Rate;Total Immunoglobulin A (IgA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma Control Test (ACT/C-ACT) Score;Forced Expiratory Volume in 1 Second (% Predicted);Fractional Exhaled Nitric Oxide (FeNO);Interferon-gamma (IFN-?);Interleukin-5 (IL-5);Interleukin-13 (IL-13);Interleukin-10 (IL-10);House Dust Mite–Specific IgG4;Total Immunoglobulin G (IgG); | — |
Countries
China
Contacts
Public ContactTingting Shi
Guangzhou Women and Children’s Medical Center,Guangzhou Medical University
Outcome results
None listed