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

AstraZeneca1,032 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,032

Conditions

Severe Asthma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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: 1. Other eosinophil lowering products indicated for asthma (including mepolizumab or reslizumab): at least 4 months. 2. 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.

Locations (12)

Research Site

Pleven, Bulgaria

Research Site

Havířov, Czechia

Research Site

Cappelle-en-Pévèle, Hauts-de-France, France

Research Site

Reinfeld, Germany

Outcomes

Primary Outcomes

Age at diagnosis

Age at diagnosis of asthma

Time frame: 1 year

Gender

Patient´s sex: Male Female

Time frame: 1 year

Ethnicity

Patient´s ethnic origin: White Black or African American Asian Other

Time frame: 1 year

Employment status

employed: full time/part time unemployed

Time frame: 1 year

Smoking status

Never former smoker current smoker

Time frame: 1 year

Blood eosinophiles (EOS)

% cells/microL

Time frame: 1 year

Immunoglobulin E (IgE) count

IU/ml

Time frame: 1 year

Fractional exhaled nitric oxide

ppb

Time frame: 1 year

Asthma medication

maintenance therapy

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of enrolled patients with severe asthma reported by investigators to be eligible for biological therapy among all enrolled patients with severe asthma

Time frame: 1 year

Comparison of age between eligible and non-eligible patients for biologic therapy

Age (years)

Time frame: 1 year

Comparison of gender between eligible and non-eligible patients for biologic therapy

Gender at study visit (male/female)

Time frame: 1 year

Comparison of ethnicity between eligible and non-eligible patients for biologic therapy

Ethnicity ( White ,Black or African American, Asian , Other )

Time frame: 1 year

Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy

Socio-economic status (employed/non employed)

Time frame: 1 year

Comparison of smoking history between eligible and non-eligible patients for biologic therapy

Smoking history (Former, current, Never smoker)

Time frame: 1 year

Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy

Blood EOS (%) or (cells/microL)

Time frame: 1 year

Comparison of IgE counts between eligible and non-eligible patients for biologic therapy

IgE count (IU/L)

Time frame: 1 year

Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy

Fractional exhaled nitric oxide (FeNO)

Time frame: 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)

Time frame: 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.

Time frame: 1 year

Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy

Pre-bronchodilator FEV1 (L/sec)

Time frame: 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)

Time frame: 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)

Time frame: 1 year

Evaluation of age dependent on chronic OCS treatment or not

Age (years)

Time frame: 1 year

Evaluation of gender dependent on chronic OCS treatment or not

Gender at study visit (male/female)

Time frame: 1 year

Evaluation of ethnicity dependent on chronic OCS treatment or not

Ethnicity ( White ,Black or African American, Asian , Other )

Time frame: 1 year

Evaluation of socio-economic status dependent on chronic OCS treatment or not

Socio-economic status (employed/non employed)

Time frame: 1 year

Evaluation of smoking history dependent on chronic OCS treatment or not

Smoking history (Former, current, Never smoker)

Time frame: 1 year

Evaluation of blood eosinophiles dependent on chronic OCS treatment or not

Blood EOS (%) or (cells/microL)

Time frame: 1 year

Evaluation of IgE counts dependent on chronic OCS treatment or not

IgE count (IU/L)

Time frame: 1 year

Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not

Fractional exhaled nitric oxide (FeNO)

Time frame: 1 year

Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not

Asthma medications (maintenance therapies)

Time frame: 1 year

Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not

Pre-bronchodilator FEV1 (L/sec)

Time frame: 1 year

Evaluation of type of exacerbations dependent on chronic OCS treatment or not

Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)

Time frame: 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)

Time frame: 1 year

Reliability of physician´s assessment on eligibility for biologic therapy referral

Physician´s assessment on eligibility for biologic therapy referral: true/false

Time frame: 1 year