Allergen immunotherapy for managing allergic asthma
Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis
This study is testing if allergen immunotherapy can help people with allergic asthma feel better compared to those getting standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 5 Years to 65 Years |
| Sex | All |
| Sponsor | General Administration of Military Health, Tunisia Research network |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tunis, Montfleury) |
| Trial ID | NCT06021912 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of allergen immunotherapy (AIT) in patients suffering from allergic asthma and allergic rhinitis compared to those receiving conventional treatments. It involves two groups: one receiving AIT and the other receiving standard care, with a focus on understanding patient responses and the role of biomarkers in predicting treatment outcomes. The study is conducted at the Pneumology Department of the Military Hospital in Tunis, where patient quality of life and symptom control are closely monitored.
Who should consider this trial
Good fit: Ideal candidates include individuals with moderate to severe persistent allergic rhinitis or asthma who have a positive allergy test and are experiencing significant symptoms.
Not a fit: Patients with multi-allergenic asthma, pregnancy, or certain comorbidities such as autoimmune diseases or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with allergic asthma and rhinitis, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promising results with allergen immunotherapy, indicating that this approach has potential for effective treatment of allergic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Tunis, Montfleury
- Military Hospital of Tunis — Tunis, Montfleury, Tunisia (Recruiting)
Study contacts
- Principal investigator: Selsabil Daboussi, Md — Pneumologie
- Study coordinator: Selsabil Daboussi, Md
- Email: selsabilhmpit@gmail.com
- Phone: 21629424692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.