e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

NCT ID: NCT06021912

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-30

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

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ITA GROUP

Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA).

Immunotherapy

Intervention Type: DRUG

Sublingual immunotherapy

STANDARD TREATMENT

patients with asthma or allergic rhinitis who have received standard allergen treatment.

Immunotherapy

Intervention Type: DRUG

Sublingual immunotherapy

Interventions

Immunotherapy

Sublingual immunotherapy

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Administration of Military Health, Tunisia

NETWORK

Sponsor Role: lead

Responsible Party

Hedi Gharsallah

DR SELSABIL Daboussi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SELSABIL DABOUSSI, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumologie

Locations

Military Hospital of Tunis

Tunis, Montfleury, Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

SELSABIL DABOUSSI, MD

Role: CONTACT

selsabilhmpit@gmail.com

21629424692 ext. 19358

Facility Contacts

Hedi Gharsallah, MD

Role: primary

gharsallahhedi@gmail.com

71391885 ext. 00216

Salsabil Daboussi, MD

Role: backup

selsabilhmpit@gmail.com

71391133 ext. 00216

Other Identifiers

efficacity of EITAG

Identifier Type: -

Identifier Source: org_study_id