Severe AsthmaRECOGNISENCT03629782
Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
An observational study of Severe Asthma, run by AstraZeneca at 12 sites in 12 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Severe Asthma
- How many people
- 1,032 participants
- Where
- 12 sitesin 12 countries
- Study dates
- 26 Apr 2018to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
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
Read the 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.
- Conditions
- Severe Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at diagnosis
Age at diagnosis of asthma
Measured: 1 year
Gender
Patient´s sex:
Male Female
Measured: 1 year
Ethnicity
Patient´s ethnic origin:
White Black or African American Asian Other
Measured: 1 year
Employment status
employed: full time/part time unemployed
Measured: 1 year
Smoking status
Never former smoker current smoker
Measured: 1 year
Blood eosinophiles (EOS)
% cells/microL
Measured: 1 year
Immunoglobulin E (IgE) count
IU/ml
Measured: 1 year
Fractional exhaled nitric oxide
ppb
Measured: 1 year
Asthma medication
maintenance therapy
Measured: 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
Measured: 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
Measured: 1 year
Pre-bronchodilator FEV1
Pre-bronchodilator FEV1
Measured: 1 year
Asthma exacerbations
number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)
Measured: 1 year
Healthcare resource use
number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 4 weeks
Medication adherence
Investigator´s discretion: yes/no
Measured: 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
Measured: 1 year
Comparison of age between eligible and non-eligible patients for biologic therapy
Age (years)
Measured: 1 year
Comparison of gender between eligible and non-eligible patients for biologic therapy
Gender at study visit (male/female)
Measured: 1 year
Comparison of ethnicity between eligible and non-eligible patients for biologic therapy
Ethnicity ( White ,Black or African American, Asian , Other )
Measured: 1 year
Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy
Socio-economic status (employed/non employed)
Measured: 1 year
Comparison of smoking history between eligible and non-eligible patients for biologic therapy
Smoking history (Former, current, Never smoker)
Measured: 1 year
Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy
Blood EOS (%) or (cells/microL)
Measured: 1 year
Comparison of IgE counts between eligible and non-eligible patients for biologic therapy
IgE count (IU/L)
Measured: 1 year
Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy
Fractional exhaled nitric oxide (FeNO)
Measured: 1 year
Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy
Asthma medications (type of maintenance therapies)
Measured: 1 year
Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy
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.
Measured: 1 year
Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy
Pre-bronchodilator FEV1 (L/sec)
Measured: 1 year
Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy
Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)
Measured: 1 year
Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy
Healthcare ressource use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)
Measured: 1 year
Evaluation of age dependent on chronic OCS treatment or not
Age (years)
Measured: 1 year
Evaluation of gender dependent on chronic OCS treatment or not
Gender at study visit (male/female)
Measured: 1 year
Evaluation of ethnicity dependent on chronic OCS treatment or not
Ethnicity ( White ,Black or African American, Asian , Other )
Measured: 1 year
Evaluation of socio-economic status dependent on chronic OCS treatment or not
Socio-economic status (employed/non employed)
Measured: 1 year
Evaluation of smoking history dependent on chronic OCS treatment or not
Smoking history (Former, current, Never smoker)
Measured: 1 year
Evaluation of blood eosinophiles dependent on chronic OCS treatment or not
Blood EOS (%) or (cells/microL)
Measured: 1 year
Evaluation of IgE counts dependent on chronic OCS treatment or not
IgE count (IU/L)
Measured: 1 year
Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not
Fractional exhaled nitric oxide (FeNO)
Measured: 1 year
Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not
Asthma medications (maintenance therapies)
Measured: 1 year
Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not
Pre-bronchodilator FEV1 (L/sec)
Measured: 1 year
Evaluation of type of exacerbations dependent on chronic OCS treatment or not
Type of exacerbations (systemic steroids/ emergency department/ inpatient hospital stay)
Measured: 1 year
Evaluation of healthcare ressource use dependent on chronic OCS treatment or not
Healthcare resosurce use (number of visits to GP, emergency room visits, hospitalisations, due to asthma)
Measured: 1 year
Reliability of physician´s assessment on eligibility for biologic therapy referral
Physician´s assessment on eligibility for biologic therapy referral: true/false
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start26 Apr 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jutta Beier, MD, Principal investigator, Deutsche Gesellschaft für Pneumologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629782
- Sponsor's protocol ID
- D3250R00039
- Acronym
- RECOGNISE
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
- ClinicalTrials.gov ID
- NCT03629782
- Acronym / sponsor ID
- RECOGNISE / D3250R00039
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at diagnosis
Time frame: 1 year
Age at diagnosis of asthma
Gender
Time frame: 1 year
Patient´s sex: Male Female
Ethnicity
Time frame: 1 year
Patient´s ethnic origin: White Black or African American Asian Other
Employment status
Time frame: 1 year
employed: full time/part time unemployed
Smoking status
Time frame: 1 year
Never former smoker current smoker
Blood eosinophiles (EOS)
Time frame: 1 year
% cells/microL
Immunoglobulin E (IgE) count
Time frame: 1 year
IU/ml
Fractional exhaled nitric oxide
Time frame: 1 year
ppb
Asthma medication
Time frame: 1 year
maintenance therapy
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
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
Pre-bronchodilator FEV1
Time frame: 1 year
Pre-bronchodilator FEV1
Asthma exacerbations
Time frame: 1 year
number severity (use of systemic inhaled corticosteroids (ICS); emergency department; inpatient hospital stay)
Healthcare resource use
Time frame: 1 year
number of visits to General Practitioner (GP), emergency room visits, hospitalizations, due to asthma
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.
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%.
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.
Medication adherence
Time frame: 1 year
Investigator´s discretion: yes/no
27 secondary outcomes
Number of enrolled patients with severe asthma reported by investigators to be eligible for biological therapy among all enrolled patients with severe asthma
Time frame: 1 year
Comparison of age between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of gender between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of ethnicity between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of socio-economic status between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of smoking history between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of blood eosinophiles between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of IgE counts between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of fractional exhaled nitric oxide between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of type of asthma medications for maintenance between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of type of oral corticosteroid use between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of pre-bronchodilator FEV1 between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of type of exacerbations between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Comparison of type of healthcare ressource use between eligible and non-eligible patients for biologic therapy
Time frame: 1 year
Evaluation of age dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of gender dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of ethnicity dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of socio-economic status dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of smoking history dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of blood eosinophiles dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of IgE counts dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of fractional exhaled nitric oxide dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of asthma medications for maintenance dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of pre-bronchodilato FEV1 dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of type of exacerbations dependent on chronic OCS treatment or not
Time frame: 1 year
Evaluation of healthcare ressource use dependent on chronic OCS treatment or not
Time frame: 1 year
Reliability of physician´s assessment on eligibility for biologic therapy referral
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jutta Beier, MD principal investigator
Deutsche Gesellschaft für Pneumologie
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Bulgaria, Czechia, France, Germany, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at diagnosis (time frame: 1 year). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.