Clinical trial NCT03629782: Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
Official title: Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients aged ≥ 18 years treated in primary or secondary care settings with diagnosed asthma defined as severe according American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines (iii).

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.

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:

  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.

Primary outcomes:
measure: Age at diagnosis
timeFrame: 1 year
measure: Gender
timeFrame: 1 year
measure: Ethnicity
timeFrame: 1 year
measure: Employment status
timeFrame: 1 year
measure: Smoking status
timeFrame: 1 year
measure: Blood eosinophiles (EOS)
timeFrame: 1 year
measure: Immunoglobulin E (IgE) count
timeFrame: 1 year
measure: Fractional exhaled nitric oxide
timeFrame: 1 year
measure: Asthma medication
timeFrame: 1 year
measure: Chronic oral corticosteroids (OCS) use
timeFrame: 1 year
measure: Short course systemic corticosteroids use
timeFrame: 1 year
measure: Pre-bronchodilator FEV1
timeFrame: 1 year
measure: Asthma exacerbations
timeFrame: 1 year
measure: Healthcare resource use
timeFrame: 1 year
measure: Charlson Comorbidity Index
timeFrame: 1 year
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: 4 weeks
measure: Asthma Control Questionnaire (ACQ-6)
timeFrame: 4 weeks
measure: Medication adherence
timeFrame: 1 year
Secondary outcomes:
measure: Number of enrolled patients with severe asthma reported by investigators to be eligible for biological therapy among all enrolled patients with severe asthma
timeFrame: 1 year
measure: Comparison of age between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of gender between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of ethnicity between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of smoking history between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of IgE counts between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy
timeFrame: 1 year
measure: Evaluation of age dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of gender dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of ethnicity dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of socio-economic status dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of smoking history dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of blood eosinophiles dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of IgE counts dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of type of exacerbations dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Evaluation of healthcare ressource use dependent on chronic OCS treatment or not
timeFrame: 1 year
measure: Reliability of physician´s assessment on eligibility for biologic therapy referral
timeFrame: 1 year
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Havirov
country: Czechia
facility: Research Site
city: Cappelle en Pevele
country: France
facility: Research Site
state: Hauts De France
city: Reinfeld
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
state: Aigaleo
city: Budapest
country: Hungary
facility: Research Site
city: Sardinia
country: Italy
facility: Research Site
state: Sassari
city: Groningen
country: Netherlands
facility: Research Site
city: Wieruszow
country: Poland
facility: Research Site
city: Bacau
country: Romania
facility: Research Site
city: Slovenj Gradec
country: Slovenia
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
state: Andalusia
Study officials:
affiliation: Deutsche Gesellschaft für Pneumologie
name: Jutta Beier, MD
role: PRINCIPAL_INVESTIGATOR
References: