Italian Registry of Allergen ImmunoTherapy

NCT06499480 | Recruiting

• 1 other identifier: 2732
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergic Respiratory Disease

Outcome Measures

Primary Outcomes (2)

• Life Quality as measured by Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) (≥12years)

  Every year to ten year

• Life Quality as measured by Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) For Children 6 - 12 years

  Every year to ten year

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

RIAIT is a prospective multicenter observational registry of patients suffering from conjunctivitis, rhinitis, and/or allergic asthma eligible for and treated with AIT according to EAACI (European Academy of Allergy and Clinical Immunology) Guidelines.

You may qualify if:

• 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.

Sponsors & Collaborators

• Società Italiana di Allergologia, Asma e Immunologia Clinica: lead
• Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP): collaborator

Study Sites (2)

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

Rozzano, Milano, 20089, Italy

RECRUITING

Azienda Ospedaliera Universitaria Istituto di Ricovero e Cura a Carattere Scientifico

Florence, Italy

RECRUITING

Study Officials

• Enrico Marco Heffler, MD, PhD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Marco Heffler, MD, PhD

CONTACT

+39 0282241; enrico.heffler@hunimed.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

IT (2)