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

NCT05114447 | Unknown

• 1 other identifier: 213698
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 4

Brief 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. 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. 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.

Conditions

Asthma; Asthma Severe Persistent Uncontrolled

Keywords

risk factors; severe/uncontrolled asthma; clinical setting; general population; longitudinal study

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• Change of asthma exacerbations (number)

  \- asthma exacerbations (mean number)

  Analyzed at baseline, month 6 and month 12.

• Change of use of systemic steroids (number)

  \- systemic steroids (number of courses)

  Analyzed at baseline, month 6 and month 12.

• Change of use of biologic therapy (number)

  \- biologic therapy (number of months)

  Analyzed at baseline, month 6 and month 12.

Secondary Outcomes (5)

• Health services use-hospitalization

  Analyzed at baseline, month 6 and month 12.

• Health services use-emergency department visits

  Analyzed at baseline, month 6 and month 12.

• Impairment of work/school (number)

  Analyzed at baseline, month 6 and month 12.

• Impairment of other daily activities (number)

  Analyzed at baseline, month 6 and month 12.

• Quality of life (score)

  Analyzed at baseline, month 6 and month 12.

Study Arms (2)

Clinical sample

a) clinical cases of severe/uncontrolled asthma attending hospital specialist centres already included in the online RItA Registry and b) 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 (Global Initiative for Asthma) step 4 level, in the last three months or b) controlled asthma with a step 5 level treatment according to GINA (Global Initiative for Asthma).

Other: Routine medical care

Epidemiological sample

a) epidemiological cases of severe/uncontrolled asthma from a general population Pisa cohort already inserted in the online RItA Registry and b) 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 12months.

Other: Routine medical care; Other: Telephone interview

Interventions

Routine medical care OTHER

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.

Clinical sample; Epidemiological sample

Telephone interview OTHER

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

Epidemiological sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Severe/uncontrolled asthma 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). 2. Severe/uncontrolled asthma subjects from a pre-existing cohort of general population living in Pisa.

You may qualify if:

• 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:
• 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)
• 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.
• 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:
• epidemiological cases of severe/uncontrolled asthma from Pisa cohort already inserted in the online RItA Registry (n=160)
• 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.

You may not qualify if:

• subjects of age \< 18 yrs
• subjects unable to participate in the study or to sign the consent form
• subjects refusing to fill in the consent form
• untraceable subjects (for the epidemiological sample)

Sponsors & Collaborators

• University of Pisa: lead
• University Hospital of Pisa: collaborator
• National Research Council, Institute of Clinical Physiology, Italy: collaborator
• University Of Perugia: collaborator
• University Hospital of Ancona: collaborator

Study Sites (4)

Leonardo Antonicelli

Ancona, 60121, Italy

Location

Nicola Murgia

Perugia, 06123, Italy

Location

Laura Carrozzi

Pisa, 56124, Italy

Location

Sandra Baldacci

Pisa, 56126, Italy

Location

Related Publications (9)

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  PMID: 24337046 BACKGROUND

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• McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.

  PMID: 30230137 BACKGROUND

• Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006 Jul;100(7):1139-51. doi: 10.1016/j.rmed.2006.03.031. Epub 2006 May 18.

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• Novelli F, Latorre M, Vergura L, Caiaffa MF, Camiciottoli G, Guarnieri G, Matucci A, Macchia L, Vianello A, Vultaggio A, Celi A, Cazzola M, Paggiaro P; Xolair Italian Study Group. Asthma control in severe asthmatics under treatment with omalizumab: a cross-sectional observational study in Italy. Pulm Pharmacol Ther. 2015 Apr;31:123-9. doi: 10.1016/j.pupt.2014.09.007. Epub 2014 Sep 30.

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  PMID: 28137489 BACKGROUND

• Maio S, Baldacci S, Bresciani M, Simoni M, Latorre M, Murgia N, Spinozzi F, Braschi M, Antonicelli L, Brunetto B, Iacovacci P, Roazzi P, Pini C, Pata M, La Grasta L, Paggiaro P, Viegi G; AGAVE group. RItA: The Italian severe/uncontrolled asthma registry. Allergy. 2018 Mar;73(3):683-695. doi: 10.1111/all.13342. Epub 2017 Nov 22.

  PMID: 29072882 BACKGROUND

• Adachi M, Kozawa M, Yoshisue H, Lee Milligan K, Nagasaki M, Sasajima T, Miyamoto T, Ohta K. Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: A long-term post-marketing study in Japan. Respir Med. 2018 Aug;141:56-63. doi: 10.1016/j.rmed.2018.06.021. Epub 2018 Jun 28.

  PMID: 30053973 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laura Carrozzi, MD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Carrozzi, MD

CONTACT

+39050995366; laura.carrozzi@unipi.it

Francesco Pistelli, MD

CONTACT

+39050995198; f.pistelli@ao-pisa.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Medicine

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: November 10, 2021
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)