Severe Eosinophilic AsthmaORBENCT04126499
Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 1 site in Spain.
Trial summary
Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Eosinophilic Asthma
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2020to 8 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be all patients who received at least one dose of benralizumab in individualized access program approved by the AEMPS.
Who may be able to join
- Adult patients (age ≥18 years)
- Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
- Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
- Informed consent signed
Who cannot join
- Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
- Refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.
Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.
Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.
- Conditions
- Severe Eosinophilic Asthma
- Medical subject headings
- Pulmonary Eosinophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age (years)
Measured: Up to 32 weeks
Sex
Male, Female
Measured: Up to 32 weeks
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: Up to 32 weeks
Smoking status
Current smoker, Ex-smoker, Never smoker
Measured: Up to 32 weeks
Age at onset of asthma diagnosis
Age (years)
Measured: Up to 32 weeks
Comorbidities
Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases
Measured: Up to 32 weeks
Severe exacerbations
Severe exacerbations in past 12 months: number and severity
Measured: Up to 32 weeks
Emergency room (ER) visits
Number of ER visits
Measured: Up to 32 weeks
Hospitalizations
Number of hospitalizations
Measured: Up to 32 weeks
Unscheduled visits
Number of unscheduled visits
Measured: Up to 32 weeks
ACT
ACT questionnaire score
Measured: Up to 32 weeks
miniAQLQ
miniAQLQ questionnaire score
Measured: Up to 32 weeks
Blood eosinophils
Blood eosinophils count (cells/microL)
Measured: Up to 32 weeks
Secondary outcomes (1)
Incidence of severe exacerbations
The incidence rate for any severe exacerbations in each calendar year will be calculated as follows: the sum of any severe exacerbations in that year divided by the total duration of follow-up in the same calendar year.
Measured: Up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start13 Jan 2020
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126499
- Sponsor's protocol ID
- D3250R00052
- Acronym
- ORBE
- Status last verified
- Jun 2021
- First submitted
- 25 Sep 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
- ClinicalTrials.gov ID
- NCT04126499
- Acronym / sponsor ID
- ORBE / D3250R00052
- Conditions
- Severe Eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 15 Oct 2019 (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.
Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.
Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.
Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be all patients who received at least one dose of benralizumab in individualized access program approved by the AEMPS.
Key inclusion criteria (4 listed)
- Adult patients (age ≥18 years)
- Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
- Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
- Informed consent signed
Key exclusion criteria (2 listed)
- Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
- Refuse to sign the informed consent
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
Time frame: Up to 32 weeks
Age (years)
Sex
Time frame: Up to 32 weeks
Male, Female
Body Mass Index (BMI)
Time frame: Up to 32 weeks
Weight and height will be combined to report BMI in kg/m^2
Smoking status
Time frame: Up to 32 weeks
Current smoker, Ex-smoker, Never smoker
Age at onset of asthma diagnosis
Time frame: Up to 32 weeks
Age (years)
Comorbidities
Time frame: Up to 32 weeks
Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases
Severe exacerbations
Time frame: Up to 32 weeks
Severe exacerbations in past 12 months: number and severity
Emergency room (ER) visits
Time frame: Up to 32 weeks
Number of ER visits
Hospitalizations
Time frame: Up to 32 weeks
Number of hospitalizations
Unscheduled visits
Time frame: Up to 32 weeks
Number of unscheduled visits
ACT
Time frame: Up to 32 weeks
ACT questionnaire score
miniAQLQ
Time frame: Up to 32 weeks
miniAQLQ questionnaire score
Blood eosinophils
Time frame: Up to 32 weeks
Blood eosinophils count (cells/microL)
1 secondary outcome
Incidence of severe exacerbations
Time frame: Up to 32 weeks
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 29 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 1 site in Spain.
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 4 inclusion and 2 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 (time frame: Up to 32 weeks). The study lists 13 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 29 Jun 2021.