Clinical trial NCT05169619: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
Official title: Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Severe Asthma
Difficult-to-treat asthma
Prevalence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Faculdade de Medicina da Universidade do Porto - CINTESIS
name: Universidade do Minho - ICVS
First posted: 2021-12-27
Enrollment: 842
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population of study will be adult (=\> 18 years) persons registered in the Portuguese National health service patients' database.

Participants will be enrolled in the study according to proportionate allocation from primary care health units that will be identified based on demographic stratification (i.e. NUTS III)

Brief summary: 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: 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.

Eligibility criteria: 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,...)

Primary outcomes:
measure: Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
Secondary outcomes:
measure: Subject's characteristics - Age
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Living in a city or rural community
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Family history
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Comorbidities and allergies
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Obesity
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Physical activity
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Health related quality of life
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Healthcare resource use and costs
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Referral
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Age of Asthma onset
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Asthma symptoms
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Pulmonary function tests
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Inflammatory biomarkers
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Exacerbations
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Emergency room (ER) visits
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Hospital admissions
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Disease Characteristics - Disease control
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Treatment Patterns - Treatment profile (current and last year)
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Treatment Patterns - Treatment adherence
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Treatment Patterns - Inhalation technique
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Gender
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Marital status
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - socio-economic and education level
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - occupational status
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Smoking status & environmental tobacco smoke
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
measure: Subject's characteristics - Health related quality of life
timeFrame: From date of inclusion until the end of the study currently planned (2,5 years)
Other outcomes:
Locations:
city: Alpendorada
country: Portugal
facility: Research Site
city: Aradas
country: Portugal
facility: Research Site
city: Arazede
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Cascais
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Fafe
country: Portugal
facility: Research Site
city: Leiria
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Mafra
country: Portugal
facility: Research Site
city: Montenegro
country: Portugal
facility: Research Site
city: Oeiras
country: Portugal
facility: Research Site
city: Ovar
country: Portugal
facility: Research Site
city: Pinhal Novo
country: Portugal
facility: Research Site
city: Ponte
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Queluz
country: Portugal
facility: Research Site
city: Quinta do Conde
country: Portugal
facility: Research Site
city: Ribeira de Pena
country: Portugal
facility: Research Site
city: Rio de Mouro
country: Portugal
facility: Research Site
city: Tavira
country: Portugal
facility: Research Site
city: Tomar
country: Portugal
facility: Research Site
city: Tondela
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Vila Cova Da Lixa
country: Portugal
facility: Research Site
city: Vila do Conde
country: Portugal
facility: Research Site
city: Vila Nova da Barquinha
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Vila Real
country: Portugal
facility: Research Site
city: Vouzela
country: Portugal
facility: Research Site
city: Évora
country: Portugal
facility: Research Site
city: Évora
country: Portugal
facility: Research Site
Study officials:
affiliation: cintesis
name: João Fonseca, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICVS
name: Jaime Correia de Sousa, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.