Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

Study Overview
=================
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.

Official Title
-----------------
Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

Conditions
-----------------
Severe Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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). 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 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age at diagnosis | Age at diagnosis of asthma | 1 year | 
| Gender | Patient´s sex: Male Female | 1 year | 
| Ethnicity | Patient´s ethnic origin: White Black or African American Asian Other | 1 year | 
| Employment status | employed: full time/part time unemployed | 1 year | 
| Smoking status | Never former smoker current smoker | 1 year | 
| Blood eosinophiles (EOS) | % cells/microL | 1 year | 
| Immunoglobulin E (IgE) count | IU/ml | 1 year | 
| Fractional exhaled nitric oxide | ppb | 1 year | 
| Asthma medication | maintenance therapy | 1 year | 
| Chronic oral corticosteroids (OCS) use | Chronic OCS use (defined as treatment maintenance with OCS for ≥50% of the previous year) dose, start / stop, frequency | 1 year | 
| Short course systemic corticosteroids use | 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 | 1 year | 
| Pre-bronchodilator FEV1 | Pre-bronchodilator FEV1 | 1 year | 
| Asthma exacerbations | number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay) | 1 year | 
| Healthcare resource use | number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma | 1 year | 
| Charlson Comorbidity Index | 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. | 1 year | 
| St George's Respiratory Questionnaire (SGRQ) | 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%. | 4 weeks | 
| Asthma Control Questionnaire (ACQ-6) | 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. | 4 weeks | 
| Medication adherence | Investigator´s discretion: yes/no | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 age between eligible and non-eligible patients for biologic therapy | Age (years) | 1 year | 
| Comparison of gender between eligible and non-eligible patients for biologic therapy | Gender at study visit (male/female) | 1 year | 
| Comparison of ethnicity between eligible and non-eligible patients for biologic therapy | Ethnicity ( White ,Black or African American, Asian , Other ) | 1 year | 
| Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy | Socio-economic status (employed/non employed) | 1 year | 
| Comparison of smoking history between eligible and non-eligible patients for biologic therapy | Smoking history (Former, current, Never smoker) | 1 year | 
| Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy | Blood EOS (%) or (cells/microL) | 1 year | 
| Comparison of IgE counts between eligible and non-eligible patients for biologic therapy | IgE count (IU/L) | 1 year | 
| Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy | Fractional exhaled nitric oxide (FeNO) | 1 year | 
| Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy | Asthma medications (type of maintenance therapies) | 1 year | 
| Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy | 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. | 1 year | 
| Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy | Pre-bronchodilator FEV1 (L/sec) | 1 year | 
| Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy | Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay) | 1 year | 
| Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy | Healthcare ressource use (number of visits to GP, emergency room visits, hospitalisations, due to asthma) | 1 year | 
| Evaluation of age dependent on chronic OCS treatment or not | Age (years) | 1 year | 
| Evaluation of gender dependent on chronic OCS treatment or not | Gender at study visit (male/female) | 1 year | 
| Evaluation of ethnicity dependent on chronic OCS treatment or not | Ethnicity ( White ,Black or African American, Asian , Other ) | 1 year | 
| Evaluation of socio-economic status dependent on chronic OCS treatment or not | Socio-economic status (employed/non employed) | 1 year | 
| Evaluation of smoking history dependent on chronic OCS treatment or not | Smoking history (Former, current, Never smoker) | 1 year | 
| Evaluation of blood eosinophiles dependent on chronic OCS treatment or not | Blood EOS (%) or (cells/microL) | 1 year | 
| Evaluation of IgE counts dependent on chronic OCS treatment or not | IgE count (IU/L) | 1 year | 
| Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not | Fractional exhaled nitric oxide (FeNO) | 1 year | 
| Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not | Asthma medications (maintenance therapies) | 1 year | 
| Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not | Pre-bronchodilator FEV1 (L/sec) | 1 year | 
| Evaluation of type of exacerbations dependent on chronic OCS treatment or not | Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay) | 1 year | 
| Evaluation of healthcare ressource use dependent on chronic OCS treatment or not | Healthcare resosurce use (number of visits to GP, emergency room visits, hospitalisations, due to asthma) | 1 year | 
| Reliability of physician´s assessment on eligibility for biologic therapy referral | Physician´s assessment on eligibility for biologic therapy referral: true/false | 1 year |