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Description/Characterisation of Asthmatics Eligible for Biologic Therapy Referral in Prim. and Sec. Care in Europe (RECOGNISE)

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ClinicalTrials.gov Identifier: NCT03629782
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a multi-country, multicentre, observational cross-sectional one-visit study of patients with severe asthma in primary and secondary care settings in Europe

Condition or disease
Severe Asthma

Detailed Description:

The aim is to generate real-life data on the characteristics of severe asthma patients in primary and secondary care settings who are eligible for biologic therapy. It is anticipated that these data, generated from the proposed large cohort across centres in Europe, will describe the unmet need for better treatments in severe asthma patients and will provide supporting evidence on the current shortcomings in referrals to specialist/secondary centres focussed on severe asthma where patients can undergo a thorough diagnostic evaluation and to develop severe asthma care paths within specialty care centres across Europe or in different healthcare systems depending on different country locations.

Approximately 2,000 other patients like you will take part in the RECOGNISE study.


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Study Type : Observational
Estimated Enrollment : 1650 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Description and Characterisation of Asthmatics Eligible for Biologic Therapy Referral Among Primary and Secondary Care Settings in Europe (RECOGNISE Study)
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Proportion of severe asthma patients of all asthmatics screened in primary and secondary care [ Time Frame: 1 year ]

    Proportion of severe asthma patients of all asthmatics screened in primary and secondary care settings in Europe, eligible for referral for biologic therapy for asthma according to the European labels for biologic therapy.

    Biologic treatments for asthma will include mepolizumab (anti-IL5), benralizumab (anti-IL5 Receptor [R]), reslizumab (anti-IL5), and omalizumab (anti-immunoglobulin E [IgE]), in the last 12 months, as assessed at the study visit.


  2. Age at diagnosis [ Time Frame: 1 year ]
    Age at diagnosis of asthma

  3. Gender [ Time Frame: 1 year ]

    Patient´s sex:

    Male Female


  4. Ethnicity [ Time Frame: 1 year ]

    Patient´s ethnic origin:

    White Black or African American Asian Other


  5. Employment status [ Time Frame: 1 year ]
    employed unemployed

  6. Smoking status [ Time Frame: 1 year ]
    former smoker current smoker

  7. Blood eosinophiles (EOS) [ Time Frame: 1 year ]
    % cells/microL

  8. Immunoglobulin E (IgE) count [ Time Frame: 1 year ]
    IU/ml

  9. Fractional exhaled nitric oxide [ Time Frame: 1 year ]
    ppb

  10. Asthma medication [ Time Frame: 1 year ]
    maintenance therapy

  11. Chronic oral corticosteroids (OCS) use [ Time Frame: 1 year ]
    Chronic OCS use (defined as treatment maintenance with OCS for ≥50% of the previous year) dose, start / stop, frequency

  12. Short course systemic corticosteroids use [ Time Frame: 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

  13. Pre-bronchodilator FEV1 [ Time Frame: 1 year ]
    Pre-bronchodilator FEV1

  14. Asthma exacerbations [ Time Frame: 1 year ]
    number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)

  15. Healthcare resource use [ Time Frame: 1 year ]
    number of visits to General Practicioner (GP), emergency room visits, hospitalisations, due to asthma

  16. Charlson Comorbidity Index [ Time Frame: 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.


  17. St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 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%.


  18. Asthma Control Questionnaire (ACQ-6) [ Time Frame: 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.

  19. Medication adherence [ Time Frame: 1 year ]
    Investigator´s discretion: yes/no


Secondary Outcome Measures :
  1. Proportion of severe asthmatics among all asthmatics screened [ Time Frame: 1 year ]
    Number of severe asthmatics of all asthmatics screened in primary and secondary care

  2. Comparison of age between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Age (years)

  3. Comparison of gender between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Gender at study visit (male/female)

  4. Comparison of ethnicity between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Ethnicity ( White ,Black or African American, Asian , Other )

  5. Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Socio-economic status (employed/non employed)

  6. Comparison of smoking history between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Smoking history (Former, current, Never smoker)

  7. Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Blood EOS (%) or (cells/microL)

  8. Comparison of IgE counts between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    IgE count (IU/L)

  9. Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Fractional exhaled nitric oxide (FeNO)

  10. Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Asthma medications (type of maintenance therapies)

  11. Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    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.

  12. Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Pre-bronchodilator FEV1 (L/sec)

  13. Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)

  14. Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy [ Time Frame: 1 year ]
    Healthcare ressource use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)

  15. Evaluation of age dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Age (years)

  16. Evaluation of gender dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Gender at study visit (male/female)

  17. Evaluation of ethnicity dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Ethnicity ( White ,Black or African American, Asian , Other )

  18. Evaluation of socio-economic status dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Socio-economic status (employed/non employed)

  19. Evaluation of smoking history dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Smoking history (Former, current, Never smoker)

  20. Evaluation of blood eosinophiles dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Blood EOS (%) or (cells/microL)

  21. Evaluation of IgE counts dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    IgE count (IU/L)

  22. Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Fractional exhaled nitric oxide (FeNO)

  23. Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Asthma medications (maintenance therapies)

  24. Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Pre-bronchodilator FEV1 (L/sec)

  25. Evaluation of type of exacerbations dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)

  26. Evaluation of healthcare ressource use dependent on chronic OCS treatment or not [ Time Frame: 1 year ]
    Healthcare resosurce use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)

  27. Reliability of physician´s assessment on eligibility for biologic therapy referral [ Time Frame: 1 year ]
    Physician´s assessment on eligibility for biologic therapy referral: true/false

  28. Direct costs [ Time Frame: 1 year ]
    Costs related to medication use and health resource use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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:

    1. Asthma medication, especially oral corticosteroid (OCS) treatment
    2. History of asthma exacerbations (including number and severity)
    3. One pre-bronchodilator forced expiratory volume in 1 sec (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629782


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Bulgaria
Research Site Recruiting
Sofia, Bulgaria
Germany
Research Site Recruiting
Reinfeld, Germany
Greece
Research Site Recruiting
Athens, Greece
Hungary
Research Site Recruiting
Budapest, Hungary
Poland
Research Site Recruiting
Wiereszow, Poland, 98400
Romania
Research Site Recruiting
Bacau, Romania
Slovenia
Research Site Recruiting
Slovenj Gradec, Slovenia
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Jutta Beier, MD Deutsche Gesellschaft für Pneumologie

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03629782     History of Changes
Other Study ID Numbers: D3250R00039
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases