Biologics and Sublingual Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: omalizumab.
- Who it may be relevant to
- Registry conditions: Asthma, Allergic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
Overview
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
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
Interventions
- Biological omalizumab
adding omalizumab to anti asthmatic therapy
Primary outcome measures
- Assess the effectiveness of combined therapy : omalizumab+ immunotherapy [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Batard T, Taille C, Guilleminault L, Bozek A, Floch VB, Pfaar O, Canonica WG, Akdis C, Shamji MH, Mascarell L. Allergen Immunotherapy for the Prevention and Treatment of Asthma. Clin Exp Allergy. 2025 Feb;55(2):111-141. doi: 10.1111/cea.14575. Epub 2024 Oct 4. PMID 39363801
Identifiers
NCT: NCT06027073 · CM-01966