Characterisation of Patients with Severe Asthma in Primary and Secondary Care Settings in Europe reported to be eligible for biological therapy - RECOGNISE

Study identifier:D3250R00039

ClinicalTrials.gov identifier:NCT03629782

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Characterisation of Patients with Severe Asthma in Primary and Secondary Care Settings in Europe reported to be eligible for biological therapy

Medical condition

Severe Asthma

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

1032

Study type

Observational

Age

18 Years - 130 Years

Date

Study Start Date: 26 Apr 2018

Primary Completion Date: 31 Jul 2020

Study Completion Date: 31 Jul 2020

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: -

Verification:

Verified 01 Feb 2021 by AstraZeneca

Collaborators

Inclusion and exclusion 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:
a. Other eosinophil lowering products indicated for asthma (including mepolizumab or reslizumab): at least 4 months.
b. 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.

No locations available

Arms	Assigned Interventions

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Jutta Beier

Deutsche Gesellschaft für Pneumologie