NCT Number: NCT06499480
Italian Registry of Allergen ImmunoTherapy
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.
Interested in participating?
Request InfoKey information
Conditions
Age range
1 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy, Rozzano, Milano, Italy
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Life Quality as measured by Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) (≥12years)
Time frame: Every year to ten year
-
Life Quality as measured by Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) For Children 6 - 12 years
Time frame: Every year to ten year
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Società Italiana di Allergologia, Asma e Immunologia Clinica
Other
Collaborators
- Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)
Registry information
Official study title
Italian Registry of Patients With Allergic Disease and Treated With Allergen ImmunoTherapy
Acronym: RIAIT
Important dates
- Study start
- 2024
- Primary completion
- 2035
- Study completion
- 2035
- First posted
- Jul 12, 2024
- Registry last updated
- Mar 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.