Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,032
- 试验地点
- 1
- 主要终点
- Gender
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Gender
时间窗: 1 year
Patient´s sex: Male Female
Immunoglobulin E (IgE) count
时间窗: 1 year
IU/ml
Employment status
时间窗: 1 year
employed: full time/part time unemployed
Smoking status
时间窗: 1 year
Never former smoker current smoker
Fractional exhaled nitric oxide
时间窗: 1 year
ppb
Asthma medication
时间窗: 1 year
maintenance therapy
Charlson Comorbidity Index
时间窗: 1 year
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.
St George's Respiratory Questionnaire (SGRQ)
时间窗: 4 weeks
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%.
Medication adherence
时间窗: 1 year
Investigator´s discretion: yes/no
Age at diagnosis
时间窗: 1 year
Age at diagnosis of asthma
Ethnicity
时间窗: 1 year
Patient´s ethnic origin: White Black or African American Asian Other
Blood eosinophiles (EOS)
时间窗: 1 year
% cells/microL
Chronic oral corticosteroids (OCS) use
时间窗: 1 year
Chronic OCS use (defined as treatment maintenance with OCS for ≥50% of the previous year) dose, start / stop, frequency
Asthma exacerbations
时间窗: 1 year
number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)
Short course systemic corticosteroids use
时间窗: 1 year
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
Pre-bronchodilator FEV1
时间窗: 1 year
Pre-bronchodilator FEV1
Asthma Control Questionnaire (ACQ-6)
时间窗: 4 weeks
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.
Healthcare resource use
时间窗: 1 year
number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma
次要结局
- Evaluation of age dependent on chronic OCS treatment or not(1 year)
- Comparison of ethnicity between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of smoking history between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of age between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of gender between eligible and non-eligible patients for biologic therapy(1 year)
- Evaluation of gender dependent on chronic OCS treatment or not(1 year)
- Evaluation of smoking history dependent on chronic OCS treatment or not(1 year)
- Evaluation of type of exacerbations dependent on chronic OCS treatment or not(1 year)
- Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy(1 year)
- Evaluation of blood eosinophiles dependent on chronic OCS treatment or not(1 year)
- Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not(1 year)
- 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 type of exacerbations between eligible and non-eligible patients for biologic therapy(1 year)
- Evaluation of ethnicity dependent on chronic OCS treatment or not(1 year)
- Evaluation of IgE counts dependent on chronic OCS treatment or not(1 year)
- Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not(1 year)
- Evaluation of socio-economic status dependent on chronic OCS treatment or not(1 year)
- Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of IgE counts between eligible and non-eligible patients for biologic therapy(1 year)
- Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy(1 year)
- Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not(1 year)
- Evaluation of healthcare ressource use dependent on chronic OCS treatment or not(1 year)
- Reliability of physician´s assessment on eligibility for biologic therapy referral(1 year)