Clinical trial

Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis

Name
efficacity of EITAG
Description
Allergy is defined as a specific abnormal and excessive reaction of the immune system to exposed allergen . This reaction is reproducible with each new exposure allergen . A recent study by The European Academy of Allergy and Clinical Immunology" (EAACI) estimates that 30% of the population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase in prevalence. Allergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases. It involves administering an increasing dose of allergens to induce immunological tolerance. The efficacy and safety of ITA have already been demonstrated. However, patient response is highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of patients, enabling prediction of response to ITA and follow-up.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-12-30
Trial end
2024-03-30
Status
Recruiting
Treatment
Immunotherapy
Sublingual immunotherapy
Arms:
ITA GROUP, STANDARD TREATMENT
Size
300
Primary endpoint
Increase in IGG1, IGG4
After 6 month of ITA
Deacresed basophil activation
After 6 month of ITA
Eligibility criteria
Inclusion Criteria Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE assay demonstrating the presence of allergens (1 or 2 allergens). A significant impact on the patient's quality of life Rhinitis associated with tracheitis or mild-to-moderate asthma. Patients with poorly controlled asthma despite optimal treatment Ineffective drug treatment Patients willing to adhere to our research protocol Exclusion Criteria: Patients with multi-allergenic asthma (more than 2 allergens) Pregnancy (at the time of ITA initiation). Autoimmune disease Immunosuppressive treatment Poorly controlled asthma HIV infection Cancer Severe psychiatric disorders. Cardiovascular diseases with a risk of complications during administration of adrenaline. Use of beta-blockers. Treatment with ACE inhibitors. Persistent lesions of the oral mucosa (chronic oral aphthosis periodontitis, etc.). Worsening of rhinitis. Acute febrile state. Recent administration of another vaccine (in this case, the ITA should not be administered on the same day). ITA should not be administered on the same day).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum sample'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-09-01

1 organization

1 drug

1 indication

Indication
Allergic Asthma