Severe AsthmaiOUTRUNNCT05603845
Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
An observational study of Severe Asthma, run by AstraZeneca at 24 sites in 8 countries.
Trial summary
This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 291 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 20 Feb 2023to 10 Apr 2025
- 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 study will recruit 410 adult patients with confirmed severe eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria in 9 countries as described above. Approximately 6-8 hospitals per country will participate in the study which have previous experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.
Who may be able to join
- Male or female patients aged 18 years or older with a physician's confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
- Severe uncontrolled eosinophilic asthma requiring high-dose* inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment.
- Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
- Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
- Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.
Who cannot join
- Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
- Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
- An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
- Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥30 days from the last dose of the previous biologic.
- Women who are currently pregnant, breastfeeding, or lactating
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
India10 sites
Research Site
Ahmedabad
Research Site
Ajmer
Research Site
Chennai
Research Site
Delhi
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Kolkata
Research Site
Pune
Research Site
Secundrabad
Research Site
Vadodara
Colombia4 sites
Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Ibague
Research Site
Pereira
United Arab Emirates3 sites
Research Site
Abu Dhabi
Research Site
Al Ain City
Research Site
Dubai
Dominican Republic2 sites
Research Site
Santiago de los Caballeros
Research Site
Santo Domingo
About this study
Official title: Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients Multicountry, Multicenter, Observational, Prospective, Primary Data, Real-world Settings
This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.
Read the detailed description
This is a multi-country, multi-center, observational, prospective study involving primary data collection within real-world pulmonary care settings for patients who receive benralizumab treatment for severe uncontrolled eosinophilic asthma.The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients will receive benralizumab injections according to the local label in the participating countries (Brazil, Argentina, Colombia, India, and the Gulf cooperative council, including the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar). No study drug will be provided as part of the study. The entire study period duration will be 56 weeks for each subject. The study is anticipated to run for approximately 18 months and is not anticipated to exceed 24 months. A database soft lock is planned at the end of the initial 8-week period of the study, and one combined descriptive and analytical interim analysis will be performed when 50% of the enrolled subjects complete the 8-week follow-up.
- Conditions
- Severe Asthma
- Keywords
- Severe Asthma, Benralizumab, Eosinophilic asthma, Patient reported outcomes
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment.
Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome
Measured: 8 weeks
Secondary outcomes (9)
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment.
Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Measured: 56 weeks
Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)
Percentage of patients with a total score improvement of ≥ 0.5 points (minimal clinically important difference [MCID]) in ACQ-6 (Asthma controlled questionnaire) at 1, 2, 3, 4, 8, 24, and 56 weeks of receiving benralizumab compared to baseline Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Measured: 56 weeks
Percentage of patients based on their Asthma control using ACQ-6
Percentage of patients with well-controlled asthma (ACQ-6 ≤ 0.75), partly controlled asthma (ACQ-6 between >0.75 and <1.5), and uncontrolled asthma (ACQ-6 ≥ 1.5) at baseline and at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Measured: 56 weeks
Patient global impression of change (PGI-C) response
The patient global impression of change (PGI-C) response at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '7' The lower the value better is the outcome
Measured: 56 weeks
Patient global impression of severity (PGI-S) response
The patient global impression of severity (PGI-S) response at 0, 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '6' The lower the value better is the outcome
Measured: 56 weeks
Pre-bronchodilator forced expiratory volume in the first second (FEV1)
Changes in the Pre-bronchodilator forced expiratory volume in the first second (Pre BD - FEV1) Unit - "ml' It will measure the change value - The higher the better
Measured: 56 weeks
Change from baseline of the patient-reported nasal polyposis symptoms
Change from baseline using the visual analog scale (VAS) for the following parameters
- Loss of smell
- Nasal blockage/nasal Congestion
- Difficulty with sleeping due to nasal symptoms
- Headache/Pressure on face
Minimum Value - '1' Maximum Value - '10' The lower the value better is the outcome.
Measured: 56 weeks
Pre-bronchodilator forced vital capacity (FVC) changes
Change in the pre-BD Forced vital capacity (FVC) changes Unit - "ml' It will measure the change value - The higher the better
Measured: 56 weeks
Percentage of patients who achieved 100 ml improvement in their lung function
Percentage of patients who achieved 100 ml improvement in their lung function (Pre BD - FEV1) This will be measured as '%' More the value better is the outcome
Measured: 56 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start20 Feb 2023
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
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
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603845
- Sponsor's protocol ID
- D3250R00113
- Acronym
- iOUTRUN
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients Multicountry, Multicenter, Observational, Prospective, Primary Data, Real-world Settings
- ClinicalTrials.gov ID
- NCT05603845
- Acronym / sponsor ID
- iOUTRUN / D3250R00113
- Conditions
- Severe Asthma
- Keywords
- Severe Asthma, Benralizumab, Eosinophilic asthma, Patient reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 3 Nov 2022 (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 study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.
Detailed description
This is a multi-country, multi-center, observational, prospective study involving primary data collection within real-world pulmonary care settings for patients who receive benralizumab treatment for severe uncontrolled eosinophilic asthma.The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients will receive benralizumab injections according to the local label in the participating countries (Brazil, Argentina, Colombia, India, and the Gulf cooperative council, including the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar). No study drug will be provided as part of the study. The entire study period duration will be 56 weeks for each subject. The study is anticipated to run for approximately 18 months and is not anticipated to exceed 24 months. A database soft lock is planned at the end of the initial 8-week period of the study, and one combined descriptive and analytical interim analysis will be performed when 50% of the enrolled subjects complete the 8-week follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 410 adult patients with confirmed severe eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria in 9 countries as described above. Approximately 6-8 hospitals per country will participate in the study which have previous experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.
Key inclusion criteria (5 listed)
- Male or female patients aged 18 years or older with a physician's confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
- Severe uncontrolled eosinophilic asthma requiring high-dose* inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment.
- Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
- Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
- Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.
Key exclusion criteria (5 listed)
- Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
- Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
- An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
- Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥30 days from the last dose of the previous biologic.
- Women who are currently pregnant, breastfeeding, or lactating
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
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
Time frame: 8 weeks
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment. Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome
9 secondary outcomes
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
Time frame: 56 weeks
Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)
Time frame: 56 weeks
Percentage of patients based on their Asthma control using ACQ-6
Time frame: 56 weeks
Patient global impression of change (PGI-C) response
Time frame: 56 weeks
Patient global impression of severity (PGI-S) response
Time frame: 56 weeks
Pre-bronchodilator forced expiratory volume in the first second (FEV1)
Time frame: 56 weeks
Change from baseline of the patient-reported nasal polyposis symptoms
Time frame: 56 weeks
Pre-bronchodilator forced vital capacity (FVC) changes
Time frame: 56 weeks
Percentage of patients who achieved 100 ml improvement in their lung function
Time frame: 56 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 10 Mar 2026.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
24 sites in 8 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 24 sites in 8 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 5 inclusion and 5 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in India, Colombia, United Arab Emirates, Dominican Republic, Saudi Arabia and 3 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?
Changes from baseline in Asthma Control Questionnaire (ACQ-6) (time frame: 8 weeks). 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 10 Mar 2026.