e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

NCT06021912 | Unknown DMC FDA Drug

• 1 other identifier: efficacity of EITAG
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Increase in IGG1, IGG4

  increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is \> 25%.

  After 6 month of ITA

• Deacresed basophil activation

  activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group

  After 6 month of ITA

Secondary Outcomes (1)

• Evalution AQLQS score(QUALITY OFLIFE)

  After 6 month of ITA

Study Arms (2)

ITA GROUP

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

Drug: Immunotherapy

STANDARD TREATMENT

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

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

Sublingual immunotherapy

ITA GROUP; STANDARD TREATMENT

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE

You may not qualify if:

• 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).

Sponsors & Collaborators

• General Administration of Military Health, Tunisia: lead

Study Sites (1)

Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• SELSABIL DABOUSSI, MD

  Pneumologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SELSABIL DABOUSSI, MD

CONTACT

21629424692; selsabilhmpit@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR SELSABIL Daboussi

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: March 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)