Severe/Uncontrolled Asthma From General Population to Clinical Setting: Update and Follow-up of the RItA Registry

Summary

Within the AGAVE project (2010-2014), funded by the 2008 AIFA (Italian Medicines Agency) Call (contract No. FARM8YRYZC), a severe/uncontrolled asthma online Registry (RItA) was implemented to assess the appropriateness of therapeutic strategies for severe/uncontrolled asthma patients, according to GINA (Global Initiative for Asthma) guidelines, in epidemiological and clinical samples. The online RItA Registry is a database containing information on patients' general characteristics, medical history, clinical data, risk factors, comorbidity, asthma exacerbations, current asthma treatment. Currently, it contains information on severe/uncontrolled asthma subjects, enrolled at national level, performing baseline (n tot=1018) and follow-up interviews (n tot=402).

Aim of the RISER study is to increase knowledge about the risk factors, diagnosis, and management of severe/uncontrolled asthma in general population and clinical setting through the update and follow-up of the RItA registry.

The RISER study is an observational longitudinal study involving a clinical setting and an epidemiological one.

The field survey will comprise one or two follow-ups according to the sample.

1. Observational longitudinal study in hospital specialist centres (clinical sample). Clinical cases of severe/uncontrolled asthma already included in the online RItA Registry and new clinical cases of severe/uncontrolled asthma attending the clinical centres and not yet included in the online RItA Registry, will be investigated at T0, T6 and T12 through a clinical form in order to collect information in accordance with the online RItA registry, and routine clinical/functional tests of asthma control.
2. Observational longitudinal study in a general population sample (epidemiological sample). Epidemiological cases of severe/uncontrolled asthma from Pisa cohort already inserted in the online RItA Registry and new epidemiological cases of severe/uncontrolled asthma from pre-existing Pisa cohort not yet included in the online RItA Registry will be investigated at T0 and T12 through a questionnaire to collect information for feeding the online RItA registry. Subjects fitting the epidemiological definition of severe/uncontrolled asthma will be invited at the Pisa clinical centre to have routine clinical/functional tests.

All data collected from clinical/epidemiological centres will be included in the RItA registry.

Overall, it is expected to enroll 422 patients.

Conditions

• Asthma
• Asthma Severe Persistent Uncontrolled

Interventions

OTHER

Routine medical care

Eligible subjects will be contacted from physicians, by telephone or directly when they attend the clinical centre for control visits. Once the patients have provided their signed informed consent, they will have to fill in the clinical form and to perform routine functional/clinical tests. Subjects will be investigated at baseline (T0), at 6-month follow-up (T6) and at 12-month follow-up (T12). All the possible variations that could occur in the patients' disease status and disease management, according to the routine medical care, will be registered and taken into account in the RISER study. RISER study is not a clinical trial, but it is an observational study without any specific drug administration by the investigators. Participants will receive interventions, which can include medical products, such as drugs or devices, or procedures, as part of their routine medical care but they will not be assigned to specific interventions by the investigator as in a clinical trial.

OTHER

Telephone interview

Eligible subjects will be contacted by telephone from trained personnel of the Research Unit. Once the signed informed consent is obtained by each enrolled subject, they will be invited to answer the phone questionnaire. Subjects will be investigated at baseline (T0) and at 12-month follow-up (T12). Subjects fitting the epidemiological definition of severe/uncontrolled asthma will be invited at the Pisa clinical centre to have routine clinical/functional tests. Each subject performing baseline clinical/functional tests at the Pisa clinical centre will be clinically and functionally re-assessed

Sponsors & Collaborators

• University Hospital of Pisa

  collaborator UNKNOWN

• National Research Council, Institute of Clinical Physiology, Italy

  collaborator OTHER

• University Of Perugia

  collaborator OTHER

• University Hospital of Ancona

  collaborator UNKNOWN

• University of Pisa

  lead OTHER

Principal Investigators

• Laura Carrozzi, MD · University of Pisa

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-30

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Italy

Study Locations