Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional TreatmentEITAGNCT06021912
e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma
An observational study of Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment
- What is being tested?
- Immunotherapy
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hospital of Tunis
Tunis, Montfleury, 1008
Hedi Gharsallah, MD, 71391885 ext. 00216, gharsallahhedi@gmail.com
Salsabil Daboussi, MD, 71391133 ext. 00216, selsabilhmpit@gmail.com
About this study
Official title: Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis
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.
Read the 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
- Being tested
- Immunotherapy
- Keywords
- ITA ASTHMA ALLERGIC RHINITIS
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Sublingual immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| ITA GROUP | Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA). Receives: Drug: Immunotherapy | |
| STANDARD TREATMENT | patients with asthma or allergic rhinitis who have received standard allergen treatment. Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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
Measured: After 6 month of ITA
Secondary outcomes (1)
Evalution AQLQS score(QUALITY OFLIFE)
Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA
Measured: After 6 month of ITA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hedi Gharsallah, General Administration of Military Health, Tunisia
- Investigators
- SELSABIL DABOUSSI, MD, Principal investigator, Pneumologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021912
- Sponsor's protocol ID
- efficacity of EITAG
- Acronym
- EITAG
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis
- ClinicalTrials.gov ID
- NCT06021912
- Acronym / sponsor ID
- EITAG / efficacity of EITAG
- Keywords
- ITA ASTHMA ALLERGIC RHINITIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITA GROUP | – | Drug: ImmunotherapyPatients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA). |
| STANDARD TREATMENT | – | Drug: Immunotherapypatients with asthma or allergic rhinitis who have received standard allergen treatment. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapySublingual immunotherapy | Drug | ITA GROUP, STANDARD TREATMENT |
Primary outcome
Increase in IGG1, IGG4
Time frame: 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
Time frame: 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
1 secondary outcome
Evalution AQLQS score(QUALITY OFLIFE)
Time frame: After 6 month of ITA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SELSABIL DABOUSSI, MD principal investigator
Pneumologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SELSABIL DABOUSSI, MD (21629424692 ext. 19358, selsabilhmpit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in IGG1, IGG4 (time frame: After 6 month of ITA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.