NCT Number: NCT05169619
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.
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Notify Me18 year and older
All sexes
Observational
Research Site, Alpendorada, Portugal
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Years
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Postal code
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
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
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
WHO classification of body mass index
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).
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.
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.
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
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Age of Asthma onset
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.
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Spirometry and reversibility testing
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,
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Number of exacerbations in the past year
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
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
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.
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
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
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Assessed by the clinician using national checklists
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Male/Female
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
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
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).
AstraZeneca
Industry
Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
Acronym: Epi-Asthma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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