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

Sponsor

General Administration of Military Health, Tunisia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06021912

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

23.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment	Drug: Immunotherapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

ITA GROUP

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

Drug: Immunotherapy

Sublingual immunotherapy

STANDARD TREATMENT

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

Drug: Immunotherapy

Sublingual immunotherapy

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 65 Years

Sexes Eligible for Study:

All

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Military Hospital of Tunis	Tunis	Montfleury	Tunisia	1008

Sponsors and Collaborators

General Administration of Military Health, Tunisia

Investigators

Principal Investigator: SELSABIL DABOUSSI, MD, Pneumologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hedi Gharsallah, DR SELSABIL Daboussi, General Administration of Military Health, Tunisia

ClinicalTrials.gov Identifier:

NCT06021912

Other Study ID Numbers:

efficacity of EITAG

First Posted:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Hedi Gharsallah, DR SELSABIL Daboussi, General Administration of Military Health, Tunisia

ITA ASTHMA ALLERGIC RHINITIS

Additional relevant MeSH terms:

Rhinitis

Asthma

Rhinitis, Allergic

Immunomodulating Agents

Study Results

No Results Posted as of Sep 1, 2023