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

NCT03629782 | Completed

• 1 other identifier: D3250R00039
• Study Type: observational
• Target: 1,032
• Locations: 12 countries
• Sites: 12

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

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (18)

• Age at diagnosis

  Age at diagnosis of asthma

  1 year

• Gender

  Patient´s sex: Male Female

  1 year

• Ethnicity

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

  1 year

• Employment status

  employed: full time/part time unemployed

  1 year

• Smoking status

  Never former smoker current smoker

  1 year

• Blood eosinophiles (EOS)

  % cells/microL

  1 year

• Immunoglobulin E (IgE) count

  IU/ml

  1 year

• Fractional exhaled nitric oxide

  ppb

  1 year

• Asthma medication

  maintenance therapy

  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

  1 year

• 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

• Pre-bronchodilator FEV1

  Pre-bronchodilator FEV1

  1 year

• Asthma exacerbations

  number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)

  1 year

• Healthcare resource use

  number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma

  1 year

• 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

• 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

• 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

• Medication adherence

  Investigator´s discretion: yes/no

  1 year

Secondary Outcomes (27)

• 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 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

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

  1 year

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

  1 year

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Pleven, 5800, Bulgaria

Location

Research Site

Havířov, 73506, Czechia

Location

Research Site

Cappelle-en-Pévèle, Hauts-de-France, 59242, France

Location

Research Site

Reinfeld, 23858, Germany

Location

Research Site

Athens, Aigaleo, 12242, Greece

Location

Research Site

Budapest, 1135, Hungary

Location

Research Site

Sardinia, Sassari, 7100, Italy

Location

Research Site

Groningen, 9745 DH, Netherlands

Location

Research Site

Wieruszów, 98400, Poland

Location

Research Site

Bacau, 600114, Romania

Location

Research Site

Slovenj Gradec, 2380, Slovenia

Location

Research Site

Málaga, Andalusia, 29004, Spain

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jutta Beier, MD

  Deutsche Gesellschaft für Pneumologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: August 14, 2018
• Study Start: April 26, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

NL (1); GR (1); HU (1); DE (1); BU (1); FR (1); IT (1); PL (1); CZ (1); ES (1); SL (1); RO (1)