e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

N/AUnknownNCT06021912

General Administration of Military Health, Tunisia300 enrolled

Overview

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.

This is a prospective, observationel study conducted in Pneumology Department at the Military Hospital in collaboration with the Immunology Laboratory We followed patients in 2 groups: Group 1: patients with asthma or allergic rhinitis who had received allergen immunotherapy (AIT). Group 2: patients with asthma or allergic rhinitis who received a conventional treatment

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Increase in IGG1, IGG4

increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is \> 25%.

Time frame: After 6 month of ITA

Deacresed basophil activation

activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group

Time frame: After 6 month of ITA

Secondary Outcomes

Evalution AQLQS score(QUALITY OFLIFE)

Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA

Time frame: After 6 month of ITA

e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts