AsthmaEpi-AsthmaNCT05169619
Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
An observational study of Asthma, run by AstraZeneca at 37 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 842 participants
- Where
- 37 sitesPortugal
- Study dates
- 30 Apr 2021to 6 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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,…)
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Portugal37 sites
Research Site
Alpendorada, Portugal, 4575-029
Research Site
Aradas, 3810-437
Research Site
Arazede, 3140-022
Research Site
Braga, 4700-395
Research Site
Cascais, 2750-642
Research Site
Coimbra, 3030-790
Research Site
Evora, 7005-389
Research Site
Evora, 7005-451
Research Site
Fafe, 4820-273
Research Site
Leiria, 2410-272
Research Site
Lisbon, 1749-080
Research Site
Lisbon, 1769-001
Research Site
Lisbon, 1800-192
Research Site
Mafra, 2640-465
Research Site
Montenegro, 8005-518
Research Site
Oeiras, 2780-163
Research Site
Ovar, 3880-225
Research Site
Pinhal Novo, 2955-050
Research Site
Ponte, 4805-273
Research Site
Porto, 4050-046
Research Site
Porto, 4100-203
Research Site
Porto, 4450-021
Research Site
Porto, 4460-282
Research Site
Queluz, 2745-862
Research Site
Quinta Do Conde, 2975-326
Research Site
Ribeira de Pena, 4870-162
Research Site
Rio de Mouro, 2635-364
Research Site
Tavira, 8800-534
Research Site
Tomar, 2300-469
Research Site
Tondela, 3460-541
Research Site
Viana do Castelo, 4900-369
Research Site
Vila Cova Da Lixa, Portugal, 4615-604
Research Site
Vila do Conde, 4480-807
Research Site
Vila Nova da Barquinha, 2260-400
Research Site
Vila Nova de Gaia, 4400-712
Research Site
Vila Real, 5000-557
Research Site
Vouzela, 3670-261
About this study
Official title: Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
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.
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma, Severe Asthma, Difficult-to-treat asthma, Prevalence
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Secondary outcomes (26)
Subject's characteristics - Age
Years
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Living in a city or rural community
Postal code
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Family history
Family history of asthma and asthma death and type of relationship
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Comorbidities and allergies
List of comorbidities with major impact on asthma outcomes
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Obesity
WHO classification of body mass index
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Physical activity
Using the brief physical activity assessment questionnaire. This brief physical activity assessment has only two questions and subjects are scored on < 4 (Insufficiently" active) and ⩾4 ("Sufficiently" active).
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Using mini AQLQ Questionnaire AQLQ is a multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-7. There are 15 questions to answer. The total score is calculated and ranges between 15 and 105. Lower scores indicate worse quality of life.
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Healthcare resource use and costs
- Direct resources will include number of inpatient admissions, emergency and hospital visits, medical appointments, diagnostic tests previously performed for asthma treatment in the last 12 months. b) Indirect resources will include reduced productivity of Asthma patients through an ad-hoc questionnaire about absenteeism (work and school days lost because of asthma) and presenteeism (reduced productivity due to asthma) in the last 12 months.
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Referral
number of patients that should be referral for asthma specialist hospital Consultation or that were referred to Severe Asthma consultation
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Age of Asthma onset
Age of Asthma onset
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Asthma symptoms
According to Control of Allergic Rhinitis and Asthma Test (CARAT). CARAT is a 10-item validated Portuguese questionnaire, which allows for the simultaneous assessment of allergic rhinitis and asthma (ARA) control. A score above 24 (min. 0; max. 30) identifies controlled asthma.
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Pulmonary function tests
Spirometry and reversibility testing
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Inflammatory biomarkers
Fractional exhaled nitric oxide (FeNO) test and blood eosinophil and neutrophil count,
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Exacerbations
Number of exacerbations in the past year
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Emergency room (ER) visits
Number of visits to emergency room (ER) within the past year
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Hospital admissions
Number of hospital admissions and mean length of hospital stay in the past year
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Disease control
According to Control of Allergic Rhinitis and Asthma Test (CARAT). CARAT is a 10-item validated Portuguese questionnaire, which allows for the simultaneous assessment of allergic rhinitis and asthma (ARA) control. A score above 24 (min. 0; max. 30) identifies controlled asthma.
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment profile (current and last year)
Stage of GINA treatment step according to GINA guidelines
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment adherence
Assessed using a Visual Analogue Scale (VAS) from 0 to 100, 0 means poor adherence and 100 good adherence
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Inhalation technique
Assessed by the clinician using national checklists
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Gender
Male/Female
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Marital status
Single, Married / De facto Union, Separated / Divorced, Widowed
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - socio-economic and education level
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - occupational status
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Smoking status & environmental tobacco smoke
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Using EQ-5D. EQ-5D is a questionnaire which include five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). and is used to evaluate the quality of life. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Measured: From date of inclusion until the end of the study currently planned (2,5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start30 Apr 2021
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade do Porto, Universidade do Minho - ICVS
- Responsible party
- Sponsor
- Investigators
- João Fonseca, MD/PhD, Principal investigator, cintesisJaime Correia de Sousa, MD/PhD, Principal investigator, ICVS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169619
- Sponsor's protocol ID
- D2287R00155
- Acronym
- Epi-Asthma
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36123070
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
- ClinicalTrials.gov ID
- NCT05169619
- Acronym / sponsor ID
- Epi-Asthma / D2287R00155
- Conditions
- Asthma
- Keywords
- Asthma, Severe Asthma, Difficult-to-treat asthma, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Universidade do Porto, Universidade do Minho - ICVS
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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,…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants
26 secondary outcomes
Subject's characteristics - Age
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Living in a city or rural community
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Family history
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Comorbidities and allergies
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Obesity
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Physical activity
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Healthcare resource use and costs
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Referral
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Age of Asthma onset
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Asthma symptoms
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Pulmonary function tests
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Inflammatory biomarkers
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Exacerbations
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Emergency room (ER) visits
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Hospital admissions
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Disease control
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment profile (current and last year)
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment adherence
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Inhalation technique
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Gender
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Marital status
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - socio-economic and education level
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - occupational status
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Smoking status & environmental tobacco smoke
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 36123070Jacome 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.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Fonseca, MD/PhD principal investigator
cintesis
Jaime Correia de Sousa, MD/PhD principal investigator
ICVS
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 37 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma (time frame: From date of inclusion until the end of the study currently planned (2,5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.