Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal

NCT ID: NCT05169619

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

842 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2024-03-06

Brief Summary

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This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.

Detailed Description

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Data on the epidemiology of asthma in Portugal were mainly grounded in studies using questionnaires and covering limited age groups. Studies assessing the prevalence of asthma diagnosis and of its sub-groups with more accurate methods are therefore needed This study aims to determine the prevalence of asthma, difficult-to-treat and severe asthma in Portugal, and to characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.

We will conduct a population-based nationwide study with a multicentre stepwise approach, enrolling 7500 adult subjects, randomly selected, from the Portuguese National Health Service patients' database of 38 primary care centres:

STAGE 0 - Phone call invitation and enrolment of participants STAGE 1 - Telephone interview survey to assess respiratory symptoms. STAGE 2 - Clinical assessment, diagnostic confirmation, and patient characterization STAGE 3 - Characterization of asthma patients (sub-group) and characterization of difficult- to-treat asthma \& severe asthma patients after 3 months follow up period.

Conditions

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Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Adults =\>18 years old registered in Portuguese National Health service patients' database of primary care units.
* Give voluntary signed informed consent,
* Ability to understand ans answer questionnaires.

Exclusion Criteria

* Participants that have a physical condition that could interfere with the study assessments or prevent the participant from adequately participating in the study (e.g. mobility problems, not able to perform spirometry,…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Medicina da Universidade do Porto - CINTESIS

UNKNOWN

Sponsor Role collaborator

Universidade do Minho - ICVS

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João Fonseca, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

cintesis

Jaime Correia de Sousa, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

ICVS

Locations

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Research Site

Alpendorada, Portugal, Portugal

Site Status

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Vila Cova Da Lixa, Portugal, Portugal

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Aradas, , Portugal

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Arazede, , Portugal

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Braga, , Portugal

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Cascais, , Portugal

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Coimbra, , Portugal

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Evora, , Portugal

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Evora, , Portugal

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Fafe, , Portugal

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Leiria, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Mafra, , Portugal

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Montenegro, , Portugal

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Oeiras, , Portugal

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Ovar, , Portugal

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Pinhal Novo, , Portugal

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Ponte, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Queluz, , Portugal

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Quinta Do Conde, , Portugal

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Ribeira de Pena, , Portugal

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Rio de Mouro, , Portugal

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Tavira, , Portugal

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Tomar, , Portugal

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Tondela, , Portugal

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Viana do Castelo, , Portugal

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Vila do Conde, , Portugal

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Vila Nova da Barquinha, , Portugal

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Vila Nova de Gaia, , Portugal

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Vila Real, , Portugal

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Vouzela, , Portugal

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Countries

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Portugal

References

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Jacome C, Brito D, Joao C, Lopes F, Santos J, Amorim L, Barbosa MJ, Pardal M, Teixeira P, Bernardo F, Fonseca JA, Correia-de-Sousa J. EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal. BMJ Open. 2022 Sep 19;12(9):e064538. doi: 10.1136/bmjopen-2022-064538.

Reference Type DERIVED
PMID: 36123070 (View on PubMed)

Other Identifiers

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D2287R00155

Identifier Type: -

Identifier Source: org_study_id

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