Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

Qianfoshan Hospital

Status: Active, not recruiting

Conditions: Allergic Asthma

Treatments: Biological: Allergen-specific immunotherapy(AIT); Biological: omalizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06771934

YXLL-KY-2024(061)

Details and patient eligibility

About

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

Enrollment: 60 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

1. Chinese patients,aged 6 years and older，female or male
2. Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
3. Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
4. The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
5. Patients who will initiate AIT or omalizumab combined with AIT according to real life clinical standards of practice.

Exclusion criteria

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

1. Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
2. Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.

4．Pregnant or planning pregnancy.

Trial design

60 participants in 2 patient groups

Allergen-specific immunotherapy alone group (AIT alone group)

Description:

Patients start to receive allergen-specific immunotherapy 1 to 3 months after asthma is under control.

Treatment:

Biological: Allergen-specific immunotherapy(AIT)

the omalizumab combined with allergen-specific immunotherapy group

Description:

Omalizumab treatment was administered 4 to 8 weeks before the initiation of standardized allergen-specific immunotherapy. After the initiation of standardized allergen-specific immunotherapy, the overlapping treatment with allergen-specific immunotherapy (AIT) and omalizumab was continued.

Treatment:

Biological: omalizumab

Biological: Allergen-specific immunotherapy(AIT)