Severe AsthmaORBE-IINCT04648839
Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.
An observational study of Severe Asthma, run by AstraZeneca at 1 site in Spain.
Trial summary
Primary Objectives: 1. To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 221 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2021to 16 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population will be all patients with severe eosinophilic asthma (those requiring stable treatment with high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller), who received at least one dose of benralizumab according to routine clinical practice, after marketing approval on January 1st, 2019. The targeted patients need to have available medical record of 12 months prior to index date.
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.
- Patients with at least 12-month data available before index date (starting benralizumab treatment)
- Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
- Informed consent signed.
Who cannot join
- Patients who received benralizumab in a clinicaltrial, during the observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.
Primary Objectives:
- To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
- To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)
This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥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 physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.
- Conditions
- Severe Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Patients that received at least one dose of benralizumab according to routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Specifically, at the time of taking the first dose of study drug
Measured: Up to 12 months (Baseline period)
Gender
Specifically, at the time of taking the first dose of study drug
Measured: Up to 12 months (Baseline period)
Smoking Habits
Measured: Up to 12 months (Baseline period)
Age at athma diagnosis
Measured: Up to 12 months (Baseline period)
Blood eosinophils count
Measured: Baseline period
Total IgE
Measured: Baseline period
Number of patients with positive Prick test
Measured: Baseline period
FeNo
Measured: Baseline period
Lung function (FEV1 and FVC)
Measured: Baseline period
ACT (or ACQ) score
Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control.
Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)
Measured: Baseline period
AQLQ score
Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is
Measured: Baseline period
Severe asthma exacerbations
Measured: In the previous 12 months
Key comorbidities
Measured: Baseline period
OCS-related comorbidities
Measured: Baseline period
Concomitant asthma medications
Measured: Baseline period
Physician office visits
Split by primary care and specialist (asthma related)
Measured: Baseline period
Emergency room visits
Measured: Baseline period
Hospitalisations
Number and duration
Measured: Baseline period
Number of laboratory tests per patient
Measured: Baseline period
Number of conventional radiology procedures per patient
Measured: Baseline period
Number of diagnostic/therapeutic tests per patient
Asthma related only
Measured: Baseline period
Number of spirometries per patient
Measured: Baseline period
Number of allergy tests per patient
Measured: Baseline period
Number of computed axial tomographies per patient
Measured: Baseline period
Number of magnetic resonance imaging procedures per patient
Measured: Baseline period
Asthma treatment
Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
Measured: Up to 24 months (study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start16 Feb 2021
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648839
- Sponsor's protocol ID
- D3250R00079
- Acronym
- ORBE-II
- Status last verified
- Aug 2022
- First submitted
- 5 Oct 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
Publications
Padilla-Galo A, Moya Carmona I, Ausin P, Carazo Fernandez L, Garcia-Moguel I, Velasco-Garrido JL, Andujar-Espinosa R, Casas-Maldonado F, Martinez-Moragon E, Martinez Rivera C, Vera Solsona E, Sanchez-Toril Lopez F, Trisan Alonso A, Blanco Aparicio M, Valverde-Monge M, Valencia Azcona B, Palop Cervera M, Nuevo J, Sanchez Tena J, Resler G, Luzon E, Levy Naon A. Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study. Respir Res. 2023 Sep 28;24(1):235. doi: 10.1186/s12931-023-02539-7.
PubMed 37770889
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.
- ClinicalTrials.gov ID
- NCT04648839
- Acronym / sponsor ID
- ORBE-II / D3250R00079
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 2 Dec 2020 (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.
Primary Objectives:
- To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
- To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)
This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥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 physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | – | –Patients that received at least one dose of benralizumab according to routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be all patients with severe eosinophilic asthma (those requiring stable treatment with high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller), who received at least one dose of benralizumab according to routine clinical practice, after marketing approval on January 1st, 2019. The targeted patients need to have available medical record of 12 months prior to index date.
Key inclusion criteria (5 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.
- Patients with at least 12-month data available before index date (starting benralizumab treatment)
- Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
- Informed consent signed.
Key exclusion criteria (1 listed)
- Patients who received benralizumab in a clinicaltrial, during the observation period.
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 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Gender
Time frame: Up to 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Smoking Habits
Time frame: Up to 12 months (Baseline period)
Age at athma diagnosis
Time frame: Up to 12 months (Baseline period)
Blood eosinophils count
Time frame: Baseline period
Total IgE
Time frame: Baseline period
Number of patients with positive Prick test
Time frame: Baseline period
FeNo
Time frame: Baseline period
Lung function (FEV1 and FVC)
Time frame: Baseline period
ACT (or ACQ) score
Time frame: Baseline period
Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control. Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)
AQLQ score
Time frame: Baseline period
Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is
Severe asthma exacerbations
Time frame: In the previous 12 months
Key comorbidities
Time frame: Baseline period
OCS-related comorbidities
Time frame: Baseline period
Concomitant asthma medications
Time frame: Baseline period
Physician office visits
Time frame: Baseline period
Split by primary care and specialist (asthma related)
Emergency room visits
Time frame: Baseline period
Hospitalisations
Time frame: Baseline period
Number and duration
Number of laboratory tests per patient
Time frame: Baseline period
Number of conventional radiology procedures per patient
Time frame: Baseline period
Number of diagnostic/therapeutic tests per patient
Time frame: Baseline period
Asthma related only
Number of spirometries per patient
Time frame: Baseline period
Number of allergy tests per patient
Time frame: Baseline period
Number of computed axial tomographies per patient
Time frame: Baseline period
Number of magnetic resonance imaging procedures per patient
Time frame: Baseline period
Asthma treatment
Time frame: Up to 24 months (study duration)
Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
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 19 Aug 2022.
- Derived from this study: PubMed 37770889Padilla-Galo A, Moya Carmona I, Ausin P, Carazo Fernandez L, Garcia-Moguel I, Velasco-Garrido JL, Andujar-Espinosa R, Casas-Maldonado F, Martinez-Moragon E, Martinez Rivera C, Vera Solsona E, Sanchez-Toril Lopez F, Trisan Alonso A, Blanco Aparicio M, Valverde-Monge M, Valencia Azcona B, Palop Cervera M, Nuevo J, Sanchez Tena J, Resler G, Luzon E, Levy Naon A. Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study. Respir Res. 2023 Sep 28;24(1):235. doi: 10.1186/s12931-023-02539-7.
- CSR SynopsisLink provided by the sponsor.
Related trials for Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
Asthma
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
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 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 5 inclusion and 1 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 19 Aug 2022. 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 12 months (Baseline period)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648839, which also lists 1 linked publication.
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 19 Aug 2022.