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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change of asthma control test (score)
Timeframe: Analyzed at baseline, month 6 and month 12.
Change of asthma control questionnaire (score)
Timeframe: Analyzed at baseline, month 6 and month 12.
Change of asthma exacerbations (number)
Timeframe: Analyzed at baseline, month 6 and month 12.
Change of use of systemic steroids (number)
Timeframe: Analyzed at baseline, month 6 and month 12.
Change of use of biologic therapy (number)
Timeframe: Analyzed at baseline, month 6 and month 12.