e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

Last updated: August 26, 2023
Sponsor: General Administration of Military Health, Tunisia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Common Cold

Asthma

Allergy

Treatment

Immunotherapy

Clinical Study ID

NCT06021912
efficacity of EITAG
  • Ages 5-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria Patients with symptoms of Asthma or moderate or severe persistentallergic rhinitis allergic rhinitis, with a positive prick test or specific IgE assaydemonstrating the presence of allergens (1 or 2 allergens). A significant impact on thepatient's quality of life Rhinitis associated with tracheitis or mild-to-moderate asthma.Patients with poorly controlled asthma despite optimal treatment Ineffective drug treatmentPatients willing to adhere to our research protocol

Exclusion

Exclusion Criteria: Patients with multi-allergenic asthma (more than 2 allergens) Pregnancy (at the time of ITAinitiation). Autoimmune disease Immunosuppressive treatment Poorly controlled asthma HIVinfection Cancer Severe psychiatric disorders. Cardiovascular diseases with a risk ofcomplications during administration of adrenaline. Use of beta-blockers. Treatment with ACEinhibitors. 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).

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Immunotherapy
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
March 30, 2024

Study Description

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

Connect with a study center

  • Military Hospital of Tunis

    Tunis, Montfleury 1008
    Tunisia

    Active - Recruiting

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