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e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06021912
Acronym
EITAG
Enrollment
300
Registered
2023-09-01
Start date
2023-03-01
Completion date
2024-03-30
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ITA ASTHMA ALLERGIC RHINITIS

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

Interventions

DRUGImmunotherapy

Sublingual immunotherapy

Sponsors

General Administration of Military Health, Tunisia
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 65 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Increase in IGG1, IGG4After 6 month of ITAincrease 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 activationAfter 6 month of ITAactivation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group

Secondary

MeasureTime frameDescription
Evalution AQLQS score(QUALITY OFLIFE)After 6 month of ITAAssessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA

Countries

Tunisia

Contacts

Primary ContactSELSABIL DABOUSSI, MD
selsabilhmpit@gmail.com21629424692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026