Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal (Epi-Asthma)
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| ClinicalTrials.gov Identifier: NCT05169619 |
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Recruitment Status :
Recruiting
First Posted : December 27, 2021
Last Update Posted : March 21, 2023
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Sponsor:
AstraZeneca
Collaborators:
Faculdade de Medicina da Universidade do Porto - CINTESIS
Universidade do Minho - ICVS
Information provided by (Responsible Party):
AstraZeneca
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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.
| Condition or disease |
|---|
| Asthma |
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 Type : | Observational |
| Estimated Enrollment : | 7500 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal |
| Actual Study Start Date : | April 30, 2021 |
| Estimated Primary Completion Date : | December 29, 2023 |
| Estimated Study Completion Date : | December 29, 2023 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Subject's characteristics - Age [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]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) ]Postal code
- Subject's characteristics - Family history [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Family history of asthma and asthma death and type of relationship
- Subject's characteristics - Comorbidities and allergies [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]List of comorbidities with major impact on asthma outcomes
- Subject's characteristics - Obesity [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]WHO classification of body mass index
- Subject's characteristics - Physical activity [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]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).
- 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) ]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.
- 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) ]a) 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.
- Subject's characteristics - Referral [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]number of patients that should be referral for asthma specialist hospital Consultation or that were referred to Severe Asthma consultation
- Disease Characteristics - Age of Asthma onset [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Age of Asthma onset
- Disease Characteristics - Asthma symptoms [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]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.
- Disease Characteristics - Pulmonary function tests [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Spirometry and reversibility testing
- Disease Characteristics - Inflammatory biomarkers [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Fractional exhaled nitric oxide (FeNO) test and blood eosinophil and neutrophil count,
- Disease Characteristics - Exacerbations [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Number of exacerbations in the past year
- Disease Characteristics - Emergency room (ER) visits [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Number of visits to emergency room (ER) within the past year
- Disease Characteristics - Hospital admissions [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Number of hospital admissions and mean length of hospital stay in the past year
- Disease Characteristics - Disease control [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]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.
- 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) ]Stage of GINA treatment step according to GINA guidelines
- Treatment Patterns - Treatment adherence [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Assessed using a Visual Analogue Scale (VAS) from 0 to 100, 0 means poor adherence and 100 good adherence
- Treatment Patterns - Inhalation technique [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Assessed by the clinician using national checklists
- Subject's characteristics - Gender [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Male/Female
- Subject's characteristics - Marital status [ Time Frame: From date of inclusion until the end of the study currently planned (2,5 years) ]Single, Married / De facto Union, Separated / Divorced, Widowed
- 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) ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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)
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,…)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169619
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
| Portugal | |
| Research Site | Active, not recruiting |
| Alpedorada, Portugal | |
| Research Site | Not yet recruiting |
| Arazede, Portugal | |
| Research Site | Not yet recruiting |
| Aveiro, Portugal | |
| Research Site | Active, not recruiting |
| Braga, Portugal | |
| Research Site | Completed |
| Cascais, Portugal | |
| Research Site | Not yet recruiting |
| Coimbra, Portugal | |
| Research Site | Not yet recruiting |
| Evora, Portugal | |
| Research Site | Recruiting |
| Fafe, Portugal | |
| Research Site | Recruiting |
| Felgueiras, Portugal | |
| Research Site | Not yet recruiting |
| Gilao De Tavira, Portugal | |
| Research Site | Not yet recruiting |
| Leiria, Portugal | |
| Research Site | Completed |
| Lisboa, Portugal | |
| Research Site | Completed |
| Mafra, Portugal | |
| Research Site | Completed |
| Massama, Portugal | |
| Research Site | Completed |
| Matosinhos, Portugal | |
| Research Site | Completed |
| Oeiras, Portugal | |
| Research Site | Not yet recruiting |
| Ovar, Portugal | |
| Research Site | Completed |
| Pinhal Novo, Portugal | |
| Research Site | Active, not recruiting |
| Ponte, Portugal | |
| Research Site | Active, not recruiting |
| Porto, Portugal | |
| Research Site | Completed |
| Quinta do Conde, Portugal | |
| Research Site | Not yet recruiting |
| Ria Formosa, Portugal | |
| Research Site | Active, not recruiting |
| Ribeiro De Pena, Portugal | |
| Research Site | Completed |
| Rio de Mouro, Portugal | |
| Research Site | Completed |
| Tomar, Portugal | |
| Research Site | Not yet recruiting |
| Tondela, Portugal | |
| Research Site | Completed |
| Torres Vedras, Portugal | |
| Research Site | Completed |
| Viana do Castelo, Portugal | |
| Research Site | Recruiting |
| Vila do Conde, Portugal | |
| Research Site | Completed |
| Vila Nova da Barquinha, Portugal | |
| Research Site | Active, not recruiting |
| Vila Nova de Gaia, Portugal | |
| Research Site | Active, not recruiting |
| Vila Real, Portugal | |
| Research Site | Not yet recruiting |
| Vouzela, Portugal | |
Sponsors and Collaborators
AstraZeneca
Faculdade de Medicina da Universidade do Porto - CINTESIS
Universidade do Minho - ICVS
Investigators
| Principal Investigator: | João Fonseca, MD/PhD | cintesis | |
| Principal Investigator: | Jaime Correia de Sousa, MD/PhD | ICVS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT05169619 |
| Other Study ID Numbers: |
D2287R00155 |
| First Posted: | December 27, 2021 Key Record Dates |
| Last Update Posted: | March 21, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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Asthma Severe Asthma Difficult-to-treat asthma Prevalence |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |