Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
- Conditions
- Severe Asthma
- Registration Number
- NCT03629782
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe
- Detailed Description
This study aims to generate real-world data on the characteristics of patients considered to have severe asthma in primary and secondary care settings that should be referred for assessment for biologics. It is anticipated that these data from European countries, will help to estimate the unmet need for better treatments in severe asthma patients and will provide supporting evidence on the current shortcomings in referrals to asthma specialist or secondary care clinics. This information could also support the development of better severe asthma care pathways across Europe.
Approximately 1,500 other patients like you will take part in the RECOGNISE study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1032
- Male or female patients aged 18 years or older with physician's confirmed diagnosis of asthma.
- Diagnosis of asthma defined as severe according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines, i.e.: Asthma requiring high-dose ICS plus at least one of the following additional controller[s] for 12 months (GINA Step 4/5): Long-acting beta2-agonist (LABA), leukotriene modifier, theophylline, or continuous or near continuous OCS [i.e.,maintenance OCS for ≥50% of the previous year])(controlled or uncontrolled). NB: High dose ICS defined according to GINA
- One documented blood EOS (%) or absolute count in the last 12 months
- Twelve months of documented baseline data in medical records or asked on study visit day including asthma medication, especially oral corticosteroid (OCS) treatment and history of asthma exacerbations (number and severity)
- Evidence of one pre-bronchodilator forced expiratory volume in the first second (FEV1) in last 12 months or on study visit day
- Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
- After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study
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Other respiratory conditions including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsine-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
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Concurrent biologics for asthma except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of the study visit). Acceptable washout periods for other asthma biologics:
- Other eosinophil lowering products indicated for asthma (including mepolizumab or reslizumab): at least 4 months.
- Prior omalizumab use: at least 1 month
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An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results
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Patient is participating in an ongoing randomized clinical trial or participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gender 1 year Patient´s sex:
Male FemaleImmunoglobulin E (IgE) count 1 year IU/ml
Employment status 1 year employed: full time/part time unemployed
Smoking status 1 year Never former smoker current smoker
Fractional exhaled nitric oxide 1 year ppb
Asthma medication 1 year maintenance therapy
Charlson Comorbidity Index 1 year Charlson Score calculated from yes/no answers to 19 questions on comorbidities and age.
Comorbidity index range = 0-37 points; Age risk range = 0-5 points; Total Index range = 0-42 points 10-years-survival rate = 0-98% The higher the points, the higher the risk and the lower the 10-years-survival rate.St George's Respiratory Questionnaire (SGRQ) 4 weeks Health related quality of life questionnaire for patients with respiratory diseases.
Subscales for "disease symptoms" , "activity", and "impact" . Each subscale can be calculated separately.
The higher the score, the more severe the disease. A total score of all scales gives a measure for the total impact of the disease, range 0-100%.Medication adherence 1 year Investigator´s discretion: yes/no
Age at diagnosis 1 year Age at diagnosis of asthma
Ethnicity 1 year Patient´s ethnic origin:
White Black or African American Asian OtherBlood eosinophiles (EOS) 1 year % cells/microL
Chronic oral corticosteroids (OCS) use 1 year Chronic OCS use (defined as treatment maintenance with OCS for ≥50% of the previous year) dose, start / stop, frequency
Asthma exacerbations 1 year number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)
Short course systemic corticosteroids use 1 year Short courses of systemic corticosteroids (or a temporary increase in a stable OCS background dose) for at least 3 days; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids dose, start / stop, frequency
Pre-bronchodilator FEV1 1 year Pre-bronchodilator FEV1
Asthma Control Questionnaire (ACQ-6) 4 weeks Level of asthma control as perceived by the patient. 6 questions with 6 predefined answers. Total points range 0 - 36. The higher, the worse the asthma control.
Healthcare resource use 1 year number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma
- Secondary Outcome Measures
Name Time Method Comparison of ethnicity between eligible and non-eligible patients for biologic therapy 1 year Ethnicity ( White ,Black or African American, Asian , Other )
Comparison of smoking history between eligible and non-eligible patients for biologic therapy 1 year Smoking history (Former, current, Never smoker)
Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy 1 year Blood EOS (%) or (cells/microL)
Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy 1 year Healthcare ressource use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)
Comparison of age between eligible and non-eligible patients for biologic therapy 1 year Age (years)
Comparison of gender between eligible and non-eligible patients for biologic therapy 1 year Gender at study visit (male/female)
Evaluation of gender dependent on chronic OCS treatment or not 1 year Gender at study visit (male/female)
Evaluation of smoking history dependent on chronic OCS treatment or not 1 year Smoking history (Former, current, Never smoker)
Evaluation of type of exacerbations dependent on chronic OCS treatment or not 1 year Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)
Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy 1 year Fractional exhaled nitric oxide (FeNO)
Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy 1 year Asthma medications (type of maintenance therapies)
Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy 1 year Pre-bronchodilator FEV1 (L/sec)
Evaluation of blood eosinophiles dependent on chronic OCS treatment or not 1 year Blood EOS (%) or (cells/microL)
Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not 1 year Fractional exhaled nitric oxide (FeNO)
Number of enrolled patients with severe asthma reported by investigators to be eligible for biological therapy among all enrolled patients with severe asthma 1 year Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy 1 year Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)
Evaluation of ethnicity dependent on chronic OCS treatment or not 1 year Ethnicity ( White ,Black or African American, Asian , Other )
Evaluation of IgE counts dependent on chronic OCS treatment or not 1 year IgE count (IU/L)
Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not 1 year Asthma medications (maintenance therapies)
Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy 1 year Socio-economic status (employed/non employed)
Comparison of IgE counts between eligible and non-eligible patients for biologic therapy 1 year IgE count (IU/L)
Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy 1 year Chronic OCS use (defined as treatment maintenance with OCS for ≥50% of the previous year) or short courses of systemic corticosteroids (or a temporary increase in a stable OCS background dose) for at least 3 days; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids.
Evaluation of age dependent on chronic OCS treatment or not 1 year Age (years)
Evaluation of socio-economic status dependent on chronic OCS treatment or not 1 year Socio-economic status (employed/non employed)
Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not 1 year Pre-bronchodilator FEV1 (L/sec)
Evaluation of healthcare ressource use dependent on chronic OCS treatment or not 1 year Healthcare resosurce use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)
Reliability of physician´s assessment on eligibility for biologic therapy referral 1 year Physician´s assessment on eligibility for biologic therapy referral: true/false
Trial Locations
- Locations (1)
Research Site
🇪🇸Malaga, Andalusia, Spain