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e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma (EITAG)

G

General Administration of Military Health, Tunisia

Status

Enrolling

Conditions

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

Treatments

Drug: Immunotherapy

Study type

Observational

Funder types

NETWORK

Identifiers

NCT06021912
efficacity of EITAG

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

5 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

300 participants in 2 patient groups

ITA GROUP
Description:
Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA).
Treatment:
Drug: Immunotherapy
STANDARD TREATMENT
Description:
patients with asthma or allergic rhinitis who have received standard allergen treatment.
Treatment:
Drug: Immunotherapy

Trial contacts and locations

1

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Central trial contact

SELSABIL DABOUSSI, MD

Data sourced from clinicaltrials.gov

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