Biologics and Sublingual Immunotherapy

Study Overview
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Brief Summary
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Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.

Detailed Description
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Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM. Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months

Official Title
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Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites

Conditions
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Asthma, Allergic

Intervention / Treatment
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* Biological: omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• >18 years old A total IgE between 30-700 IU/mL Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma; FEV1 >70% at baseline; Positive skin prick test results for D. pteronyssinus, D. farinae Exclusion Criteria: Sensitisation to other allergens with clinical signs not related to HDM Uncontrolled asthma, Other serious diseases or chronic unstable diseases Allergen immunotherapy during the past 5 years Contraindicating allergen immunotherapy and omalizumab treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows: Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: omalizumab<br>standard antiasthmatic therapy and omalizumab | Biological: omalizumab<br>* adding omalizumab to anti asthmatic therapy<br>|
| Active Comparator: oral tablet HDM-immunotherapy<br>standard antiasthmatic therapy and oral immunotherapy | Biological: omalizumab<br>* adding omalizumab to anti asthmatic therapy<br>|
| Active Comparator: combi therapy<br>standard antiasthmatic therapy and omalizumab, and oral immunotherapy | Biological: omalizumab<br>* adding omalizumab to anti asthmatic therapy<br>|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effectiveness of combined therapy : omalizumab+ immunotherapy | Daily dose of inhaled steroids (changes) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgE, asthma, omalizumab, immunotherapy