Allergic Respiratory DiseaseRIAITNCT06499480
Italian Registry of Allergen ImmunoTherapy
An observational study of Allergic Respiratory Disease, run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Allergic Respiratory Disease
- How many people
- 5,000 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2024to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Istituto di Ricovero e Cura a Carattere Scientifico
Florence
Mattia Giovannini, MD
- Recruiting
Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy
Rozzano, Milano, 20089
Enrico Marco Heffler, MD, PhD
About this study
Official title: Italian Registry of Patients With Allergic Disease and Treated With 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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality as measured by Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) (≥12years)
Measured: Every year to ten year
Life Quality as measured by Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) For Children 6 - 12 years
Measured: Every year to ten year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 May 2024
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)
- Responsible party
- Sponsor
- Investigators
- Enrico Marco Heffler, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499480
- Sponsor's protocol ID
- 2732
- Acronym
- RIAIT
- Status last verified
- Mar 2025
- First submitted
- 5 Jul 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry of Patients With Allergic Disease and Treated With Allergen ImmunoTherapy
- ClinicalTrials.gov ID
- NCT06499480
- Acronym / sponsor ID
- RIAIT / 2732
- Conditions
- Allergic Respiratory Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Società Italiana di Allergologia, Asma e Immunologia ClinicaUniversity, hospital or other
- Collaborators
- Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Related trials for Allergic Respiratory Disease
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Marco Heffler, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Respiratory Disease, run by Società Italiana di Allergologia, Asma e Immunologia Clinica at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Marco Heffler, MD, PhD (+39 0282241, enrico.heffler@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Quality as measured by Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) (≥12years) (time frame: Every year to ten year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.