Asthma Clinical Trial
— RISEROfficial title:
RIsk Factors, Diagnosis, and Management of SEvere/Uncontrolled Asthma From General Population to Clinical Setting: Update and Follow-up of the RItA Registry
NCT number | NCT05114447 |
Other study ID # | 213698 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2022 |
Est. completion date | June 2023 |
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.
Status | Not yet recruiting |
Enrollment | 422 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria 1. Observational longitudinal study in hospital specialist centres (clinical sample) Target population consists of asthmatic adult patients managed by clinical centres in Pisa (Unit of Pulmonology, Cardio-Thoracic and Vascular Department), Perugia (Section of Occupational Medicine, Respiratory Diseases and Toxicology, Medicine Department), Ancona (Unit of Allergology, Internal Medicine Department). In particular, the eligible patients for RISER study are: 1. clinical cases of severe/uncontrolled asthma already included in the online RItA Registry (number: 244 total; n=75 Pisa; n=114 Perugia; n=55 Ancona) 2. new clinical cases of severe/uncontrolled asthma attending the clinical centres and not yet included in the online RItA Registry, with the following characteristics: adult subjects with a diagnosis of asthma since at least one year with a) uncontrolled asthma, despite regular treatment with GINA step 4 level, in the last three months or b) controlled asthma with a step 5 level treatment according to GINA. The expected number will be of 115 in total: n=50 Pisa; n=35 Perugia; n=30 Ancona. 2. Observational longitudinal study in a general population sample (epidemiological sample) Target population consists of adults suffering from asthmatic symptoms or having an asthma diagnosis within a general population sample investigated in three subsequent cross-sectional surveys in Pisa (the 1st survey (PI1) performed in 1985-1988 on 3865 subjects; the 2nd survey(PI2) in 1991-1993 on 2841 subjects; the 3rd survey (PI3) in 2009-2011 on 1620 subjects). In particular, the eligible subjects for RISER study are: 1. epidemiological cases of severe/uncontrolled asthma from Pisa cohort already inserted in the online RItA Registry (n=160) 2. new epidemiological cases of severe/uncontrolled asthma from pre-existing Pisa cohort not yet included in the online RItA Registry, with the following characteristics: adult subjects with at least one asthma attack in the last 12 months or wheezing and/or asthma therapy in the last 12 months. The expected number, on the basis of the severe/uncontrolled asthma prevalence obtained in previous studies, is 34. Exclusion Criteria 1. subjects of age < 18 yrs 2. subjects unable to participate in the study or to sign the consent form 3. subjects refusing to fill in the consent form 4. untraceable subjects (for the epidemiological sample) No other specific exclusion criterion will be considered, in order to capture all potential variables influencing severe/uncontrolled asthma outcomes in real life. |
Country | Name | City | State |
---|---|---|---|
Italy | Leonardo Antonicelli | Ancona | |
Italy | Nicola Murgia | Perugia | |
Italy | Laura Carrozzi | Pisa | |
Italy | Sandra Baldacci | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa | National Research Council, Institute of Clinical Physiology, Italy, University Hospital of Ancona, University Hospital of Pisa, University Of Perugia |
Italy,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of asthma control test (score) | - asthma control test - ACT (score range 5-25, with higher scores indicating greater asthma control) (mean score) | Analyzed at baseline, month 6 and month 12. | |
Primary | Change of asthma control questionnaire (score) | - asthma control questionnaire - ACQ (score range 0- 6, with lower scores indicating greater asthma control) (mean score) | Analyzed at baseline, month 6 and month 12. | |
Primary | Change of asthma exacerbations (number) | - asthma exacerbations (mean number) | Analyzed at baseline, month 6 and month 12. | |
Primary | Change of use of systemic steroids (number) | - systemic steroids (number of courses) | Analyzed at baseline, month 6 and month 12. | |
Primary | Change of use of biologic therapy (number) | - biologic therapy (number of months) | Analyzed at baseline, month 6 and month 12. | |
Secondary | Health services use-hospitalization | - hospitalization (number of hospitalization due to asthma) | Analyzed at baseline, month 6 and month 12. | |
Secondary | Health services use-emergency department visits | - emergency department (ED) visit (number of ED visits due to asthma) | Analyzed at baseline, month 6 and month 12. | |
Secondary | Impairment of work/school (number) | - work/school absenteeism (number of days) | Analyzed at baseline, month 6 and month 12. | |
Secondary | Impairment of other daily activities (number) | - limitations in daily activities (number of days) | Analyzed at baseline, month 6 and month 12. | |
Secondary | Quality of life (score) | Quality of life score (Asthma Quality of Life Questionnaire; global score range 1-7 with higher scores indicating better quality of life) | Analyzed at baseline, month 6 and month 12. |
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