Italian Registry of Allergen ImmunoTherapy

NCT ID: NCT06499480

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2035-12-31

Brief Summary

RIAIT (Italian Registry of Allergy Immunotherapy) is a multicenter observational study that aims to prospectively collect the most extensive data available on Italian patients using AIT for respiratory allergies (rhinoconjunctivitis and/or asthma) in a real-life context, through a network of allergy centers with specific interest and expertise in the management of allergic respiratory patients.

Detailed Description

Objectives include:

• Evaluate short and long-term real-life effectiveness and safety of AIT overall, in specific patient groups' phenotypes and with specific AIT products.
• Evaluate the pertinence and differences in suggesting AIT to a patient comparing physician's evaluation in various settings with established international guidelines, describing the factors associated with treatment choices and changing over time, and promoting interoperability, data sharing, and cross-comparison among centers.
• Describe long-term respiratory allergic disease evolution in patients treated with AIT.
• Describe the natural history of the patient population with respiratory allergies and identify patient groups describing their illness burden, management patterns, and clinical progression.
• Promote the creation of accurate, standardized, and efficient processes for diagnosing and treating respiratory allergic diseases, especially with AIT.
• Assess biomarker data to predict diagnosis, treatment response and long-term disease progression.

Conditions

Allergic Respiratory Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)

UNKNOWN

Sponsor Role: collaborator

Società Italiana di Allergologia, Asma e Immunologia Clinica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Marco Heffler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

Rozzano, Milano, Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Istituto di Ricovero e Cura a Carattere Scientifico

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enrico Marco Heffler, MD, PhD

Role: CONTACT

enrico.heffler@hunimed.eu

+39 0282241

Other Identifiers

2732

Identifier Type: -

Identifier Source: org_study_id