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

Study Overview
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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.

Official Title
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Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal

Conditions
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Asthma

Participation Criteria
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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,…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From date of inclusion until the end of the study currently planned (2,5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's characteristics - Age | Years | 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 | 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 | 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 | 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 | 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). | 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. | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Subject's characteristics - Healthcare resource use and costs | 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. | 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 | 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 | 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. | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Disease Characteristics - Pulmonary function tests | Spirometry and reversibility testing | 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, | 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 | 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 | 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 | 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. | 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 | 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 | 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 | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Subject's characteristics - Gender | Male/Female | 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 | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Subject's characteristics - socio-economic and education level |  | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Subject's characteristics - occupational status |  | From date of inclusion until the end of the study currently planned (2,5 years) | 
| Subject's characteristics - Smoking status & environmental tobacco smoke |  | 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). | From date of inclusion until the end of the study currently planned (2,5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Severe Asthma, Difficult-to-treat asthma, Prevalence