Registry for Allergen Immunotherapy in Italy
Italian Registry of Patients With Allergic Disease and Treated With Allergen ImmunoTherapy
This study is collecting information from Italian patients receiving allergy shots to see how well they work for conditions like asthma and hay fever in everyday life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Società Italiana di Allergologia, Asma e Immunologia Clinica Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Rozzano, Milano and 1 other locations) |
| Trial ID | NCT06499480 on ClinicalTrials.gov |
What this trial studies
The Italian Registry of Allergy Immunotherapy (RIAIT) is a multicenter observational initiative aimed at collecting extensive data on Italian patients undergoing allergen immunotherapy (AIT) for respiratory allergies, such as rhinoconjunctivitis and asthma. The study evaluates the effectiveness and safety of AIT in real-life settings, assesses treatment decisions against international guidelines, and describes the long-term evolution of respiratory allergic diseases. It also aims to identify patient groups based on illness burden and management patterns while promoting standardized processes for diagnosis and treatment. Additionally, biomarker data will be analyzed to predict treatment responses and disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 1 year and older with a confirmed diagnosis of allergic rhinoconjunctivitis and/or allergic asthma who have been monitored by a recruiting center for at least one month.
Not a fit: Patients who do not have a confirmed diagnosis of allergic respiratory diseases or those who have not been followed by a recruiting center for the required observation period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of allergic respiratory diseases, leading to improved patient outcomes through tailored immunotherapy.
How similar studies have performed: Other studies have shown success with similar observational approaches in understanding the effectiveness of allergen immunotherapy, making this study a valuable addition to existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 1 year * Confirmed diagnosis of allergic rhinoconjunctivitis and/or allergic asthma according to EAACI 2019 guidelines. * Having been followed by the recruiting center for at least one month: this is considered necessary to establish that the patients are truly affected by allergic respiratory disease and are eligible for allergen-specific immunotherapy; in this period, screening tests are carried out to exclude and/or confirm concomitant diseases (comorbidities). In fact, according to the aforementioned EAACI guidelines, a patient can be defined as truly eligible for allergen-specific immunotherapy only after a preliminary phase in which the patient is treated with symptomatic therapy; this observation period allows a correct evaluation of the real adherence and response to therapy, as well as the identification and appropriate treatment of any comorbidity and the possible elimination of aggravating factors. * Having received the prescription of any of the available AIT products in Italy, irrespectively of the selected allergens and the administration route and schedule. Exclusion Criteria: There will no be exclusion criteria, in order to allow a real-life vision of the characteristics of these patients eligible for or treated with allergen-specific immunotherapy.
Where this trial is running
Rozzano, Milano and 1 other locations
- Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy — Rozzano, Milano, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Istituto di Ricovero e Cura a Carattere Scientifico — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Enrico Marco Heffler, MD, PhD — Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study coordinator: Enrico Marco Heffler, MD, PhD
- Email: enrico.heffler@hunimed.eu
- Phone: +39 0282241
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.