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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergen-specific immunotherapy alone group (AIT alone group) | Patients start to receive allergen-specific immunotherapy 1 to 3 months after asthma is under control. |
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| the omalizumab combined with allergen-specific immunotherapy group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergen-specific immunotherapy(AIT) | Biological | Allergen-Specific Immunotherapy(AIT) Protocol: using the house dust mite allergen preparation (Alutard, ALK Company, Denmark). The treatment course was divided into the initial treatment stage and the maintenance treatment stage. The initial treatment stage, also known as the dose accumulation stage, involved injecting the vaccine once a week and usually lasted for 15 weeks. For highly sensitive patients, treatment was carried out according to the dose guidelines for "high sensitivity". The maximum dose in the initial treatment stage was the maintenance dose. After reaching the maintenance dose, the first maintenance injection was given 2 weeks later, the second maintenance injection was given 4 weeks later, and thereafter, a vaccine injection was carried out every 4 - 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence rate of adverse reactions in standardized allergen immunotherapy | Adverse reactions of allergen immunotherapy (AIT) can be divided into local adverse reactions and systemic adverse reactions according to the occurrence sites. Local adverse reactions mainly include itching, redness, swelling, induration and even necrosis at the allergen injection sites. Systemic adverse reactions of AIT include cough, dyspnea, urticaria, asthma attacks and so on, and can lead to anaphylactic shock in severe cases.In this study, the incidence rates of adverse reactions in the two groups of patients were taken as the main research indicators to evaluate the role of omalizumab in the process of desensitization treatment. | The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year. |
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Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
4．Pregnant or planning pregnancy.
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The study population consists of patients with moderate to severe allergic asthma who are aged 6 years or older in the Chinese population, have dust mites as the main allergens, and are receiving standardized allergen-specific immunotherapy or omalizumab combined with standardized allergen-specific immunotherapy in our hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital,The First Affliated Hospital of Shandong First Medical University | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| C562694 | Epilepsy, Idiopathic Generalized |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| omalizumab | Biological | Omalizumab Treatment Protocol: The dosage and administration frequency (once every 2 weeks or once every 4 weeks) of omalizumab were determined based on the patients' pretreatment serum total IgE (kU/L), age, and body weight (kg). Each dosage ranged from 15 to 600 mg and was administered subcutaneously. If the dosage was ≤ 150 mg, it was injected subcutaneously at 1 site; otherwise, it was injected subcutaneously at 1 to 4 sites respectively. After the first 3 injections, patients were observed in the hospital for at least 2 hours, and after the 4th and subsequent injections, they were observed for at least 30 minutes. During the treatment period, the background medications for asthma control were adjusted according to the patient's condition. |
|
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |