e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

Recruiting

• Conditions: Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment
• Interventions: Drug: Immunotherapy

• Registration Number: NCT06021912
• Lead Sponsor: General Administration of Military Health, Tunisia

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-26
• Last Update Submitted: 2023-08-26
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Increase in IGG1, IGG4	After 6 month of ITA	increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is \> 25%.
Deacresed basophil activation	After 6 month of ITA	activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group

Secondary Outcome Measures

Name	Time	Method
Evalution AQLQS score(QUALITY OFLIFE)	After 6 month of ITA	Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA

Trial Locations

Locations (1)

Military Hospital of Tunis; 🇹🇳 Tunis, Montfleury, Tunisia