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

Severe Asthma Clinical Trial

— RECOGNISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629782
• Other study ID #: D3250R00039
• Status: Completed
• Start date: April 26, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Bulgaria	Research Site	Pleven
Czechia	Research Site	Havirov
France	Research Site	Cappelle en Pevele	Hauts De France
Germany	Research Site	Reinfeld
Greece	Research Site	Athens	Aigaleo
Hungary	Research Site	Budapest
Italy	Research Site	Sardinia	Sassari
Netherlands	Research Site	Groningen
Poland	Research Site	Wieruszow
Romania	Research Site	Bacau
Slovenia	Research Site	Slovenj Gradec
Spain	Research Site	Malaga	Andalusia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Romania,  Slovenia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at diagnosis	Age at diagnosis of asthma	1 year
Primary	Gender	Patient´s sex: Male Female	1 year
Primary	Ethnicity	Patient´s ethnic origin: White Black or African American Asian Other	1 year
Primary	Employment status	employed: full time/part time unemployed	1 year
Primary	Smoking status	Never former smoker current smoker	1 year
Primary	Blood eosinophiles (EOS)	% cells/microL	1 year
Primary	Immunoglobulin E (IgE) count	IU/ml	1 year
Primary	Fractional exhaled nitric oxide	ppb	1 year
Primary	Asthma medication	maintenance therapy	1 year
Primary	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
Primary	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
Primary	Pre-bronchodilator FEV1	Pre-bronchodilator FEV1	1 year
Primary	Asthma exacerbations	number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)	1 year
Primary	Healthcare resource use	number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma	1 year
Primary	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
Primary	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
Primary	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
Primary	Medication adherence	Investigator´s discretion: yes/no	1 year
Secondary	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
Secondary	Comparison of age between eligible and non-eligible patients for biologic therapy	Age (years)	1 year
Secondary	Comparison of gender between eligible and non-eligible patients for biologic therapy	Gender at study visit (male/female)	1 year
Secondary	Comparison of ethnicity between eligible and non-eligible patients for biologic therapy	Ethnicity ( White ,Black or African American, Asian , Other )	1 year
Secondary	Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy	Socio-economic status (employed/non employed)	1 year
Secondary	Comparison of smoking history between eligible and non-eligible patients for biologic therapy	Smoking history (Former, current, Never smoker)	1 year
Secondary	Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy	Blood EOS (%) or (cells/microL)	1 year
Secondary	Comparison of IgE counts between eligible and non-eligible patients for biologic therapy	IgE count (IU/L)	1 year
Secondary	Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy	Fractional exhaled nitric oxide (FeNO)	1 year
Secondary	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
Secondary	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
Secondary	Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy	Pre-bronchodilator FEV1 (L/sec)	1 year
Secondary	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
Secondary	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
Secondary	Evaluation of age dependent on chronic OCS treatment or not	Age (years)	1 year
Secondary	Evaluation of gender dependent on chronic OCS treatment or not	Gender at study visit (male/female)	1 year
Secondary	Evaluation of ethnicity dependent on chronic OCS treatment or not	Ethnicity ( White ,Black or African American, Asian , Other )	1 year
Secondary	Evaluation of socio-economic status dependent on chronic OCS treatment or not	Socio-economic status (employed/non employed)	1 year
Secondary	Evaluation of smoking history dependent on chronic OCS treatment or not	Smoking history (Former, current, Never smoker)	1 year
Secondary	Evaluation of blood eosinophiles dependent on chronic OCS treatment or not	Blood EOS (%) or (cells/microL)	1 year
Secondary	Evaluation of IgE counts dependent on chronic OCS treatment or not	IgE count (IU/L)	1 year
Secondary	Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not	Fractional exhaled nitric oxide (FeNO)	1 year
Secondary	Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not	Asthma medications (maintenance therapies)	1 year
Secondary	Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not	Pre-bronchodilator FEV1 (L/sec)	1 year
Secondary	Evaluation of type of exacerbations dependent on chronic OCS treatment or not	Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)	1 year
Secondary	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
Secondary	Reliability of physician´s assessment on eligibility for biologic therapy referral	Physician´s assessment on eligibility for biologic therapy referral: true/false	1 year

External Links

•   CSR Synopsis