Non-cystic Fibrosis BronchiectasisPhase 3MAHALENCT05006573
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 3 study testing Benralizumab in people with Non-cystic Fibrosis Bronchiectasis, run by AstraZeneca at 48 sites in 16 countries.
Trial summary
This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 48 sitesin 16 countries
- Study dates
- 21 Jul 2021to 16 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male or female, at least 18 years of age inclusive at the time of signing the ICF
- Must have NCFB diagnosed by a physician and confirmed by CT (measured at screening; if a new CT is not possible, a CT performed within 12 months of the screening visit is acceptable).
- Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.
- If receiving prophylactic systemic or inhaled antibiotics to prevent bronchiectasis exacerbations, the dose/regimen must be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study. If prophylactic macrolides have been recently discontinued, patients must have been off treatment for at least 3 months prior to randomisation. In all other cases of prophylactic antibiotic use, ≥ 4 weeks wash out period should be in place after the last dose of antibiotic and prior to randomisation
- Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The dose and regimen of these therapies and any drugs used to aid expectoration should be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study.
- If receiving inhaled corticosteroid or bronchodilator therapy, the dose and regimen should be stable with no alteration to dose or formulation for at least 3 months prior to the screening visit and this should remain stable throughout the DB period of the study.
- Women of childbearing potential (WOCBP) must have a negative serum and urine pregnancy test prior to randomization and agree to use a highly effective method of birth control from enrollment, throughout the study duration, and for 12 weeks after the last dose of IP.
Who cannot join
- Pulmonary disease other than bronchiectasis. Patients with a history of NTM disease may be enrolled if they have completed treatment prior to the Screening visit, if at least 3 months have elapsed since the last day of antibiotic treatment for NTM at the Screening visit, and if they have had a negative sputum culture prior to the screening visit.
- Another diagnosed or suspected pulmonary or systemic disease associated with elevated peripheral eosinophil counts
- Respiratory infection or bronchiectasis exacerbation during the screening period.
- Any other clinical condition that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient during the study.
- Influence the findings of the study or their interpretation.
Show all 30Show fewer
- Impede the patient's ability to complete the entire duration of the study.
- Radiological findings suggestive of a respiratory disease other than bronchiectasis, suggestive of acute infection, or of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care. Pulmonary nodules > 6 mm in size should have at least 2 years of follow up with no change on CT imaging.
- Current active liver disease
- Current malignancy, or history of malignancy, except for:
- Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided the patient is in remission and curative therapy was completed at least 12 months prior to Visit 1
- Patients who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to Visit 1.
- History of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2.
- History of alcohol or drug abuse within the past year
- Current smokers with a tobacco history of ≥ 10 pack-years or ex-smoker with a tobacco history of ≥ 10 pack-years.
- Patients receiving long-term oxygen treatment
- Patients participating in, or scheduled for, an intensive (active) pulmonary rehabilitation programme. Patients who are in the maintenance phase of a rehabilitation programme are eligible.
- Use of non-invasive positive-pressure ventilation for conditions other than obstructive sleep apnoea
- Use of immunosuppressive medication within 3 months of the screening visit or expected need for chronic use (≥ 4 weeks) during study
- Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within one year of the screening visit
- Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to randomisation
- Receipt of immunoglobulin and blood products within 30 days of the date of the screening visit
- Receipt of live attenuated vaccines within 30 days of the date of randomisation
- Concurrent enrolment in another clinical drug interventional trial
- History of anaphylaxis to any biologic therapy or vaccine
- Known history of allergy or reaction to any component of the IP formulation.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
- Previous randomisation in the present study
- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Trial locations and contacts
48 sites in 16 countries.
48 sites in 16 countries
United States4 sites
Research Site
Birmingham, Alabama, 35233
Research Site
El Paso, Texas, 79902
Research Site
Newport Beach, California, 92663
Research Site
Northridge, California, 91324
China4 sites
Research Site
Guangzhou, 510120
Research Site
Guangzhou
Research Site
Shanghai, 200032
Research Site
Zhengzhou, 450000
Denmark4 sites
Research Site
Aalborg, 9000
Research Site
Hellerup, 2900
Research Site
Hvidovre, 2650
Research Site
Vejle, 7100
Germany4 sites
Research Site
Essen, 45239
Research Site
Frankfurt, 60590
Research Site
Gauting, 82131
Research Site
München, D-80336
Italy4 sites
Research Site
Milan, 20122
Research Site
Pisa, 56100
Research Site
Roma, 00168
Research Site
Rozzano, 20089
South Korea4 sites
Research Site
Jeonju, 54907
Research Site
Seoul, 04763
Research Site
Seoul, 05030
Research Site
Seoul, 06591
Argentina3 sites
Research Site
Florida, B1602DQD
Research Site
San Fernando, B1646EBJ
Research Site
San Miguel de Tucumán, 4000
Canada3 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Windsor, Ontario, N8X-5A6
India3 sites
Research Site
Coimbatore, 641028
Research Site
Hyderabad, 500084
Research Site
New Delhi, 100049
Poland3 sites
Research Site
Bydgoszcz, 85-079
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Wroclaw, 54-239
Russia3 sites
Research Site
Penza, 440067
Research Site
Saratov, 410012
Research Site
Ulyanovsk, 432009
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh, 70000
Australia2 sites
Research Site
Melbourne, 3004
Research Site
South Brisbane, 4101
About this study
Official title: A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)
This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI).
All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab.
The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- Benralizumab, Placebo to Benralizumab
- Keywords
- Benralizumab, Non-cystic Fibrosis Bronchiectasis, Eosinophlic Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Benralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Placebo to BenralizumabBiological
Matching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS) Receives: Biological: Benralizumab |
| Placebo | Placebo comparator | Matching placebo solution will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS) Receives: Biological: Placebo to Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Secondary outcomes (12)
Time to First Exacerbation in the Double-blind Treatment Period
Time to first NCFB exacerbation in the double-blind treatment period
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms Scale over the double-blind treatment period. QoL-B-RSS scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in LCQ Total Score Over the Double-blind Period
Change from baseline in Leicester Cough Questionnaire (LCQ) total score over the double-blind treatment period. LCQ total scores range from 3 to 21. Higher scores indicate better quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Physical Functioning Scale. QoL-B Physical Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Role Functioning Scale. QoL-B Role Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Emotional Functioning Scale. QoL-B Emotional Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Social Functioning Scale. QoL-B Social Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Vitality Scale. QoL-B Vitality Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Health Perceptions Scale. QoL-B Health Perceptions Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Treatment Burden Scale. QoL-B Treatment Burden Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over the double-blind treatment period. SGRQ total scores range from 0 to 100. 100 represents the worst possible health status and 0 indicates the best possible health status.
Measured: through Double-blind period, at least 28 weeks and up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start21 Jul 2021
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Why it stopped: Due to the decision to stop recruitment early, enrolment into the MAHALE trial was terminated in August 2022; 139 patients were screened and 100 randomised to IP.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James D. Chalmers, MD, Principal investigator, University of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006573
- Sponsor's protocol ID
- D325BC00001
- Other IDs
- 2020-004068-24
- Acronym
- MAHALE
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2021
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)
- ClinicalTrials.gov ID
- NCT05006573
- Acronym / sponsor ID
- MAHALE / D325BC00001
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- Benralizumab, Non-cystic Fibrosis Bronchiectasis, Eosinophlic Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the decision to stop recruitment early, enrolment into the MAHALE trial was terminated in August 2022; 139 patients were screened and 100 randomised to IP.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Posted 20 Jul 2025
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 multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI).
All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab.
The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Biological: BenralizumabBenralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS) |
| Placebo | Placebo comparator | Biological: Placebo to BenralizumabMatching placebo solution will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS) |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, at least 18 years of age inclusive at the time of signing the ICF
- Must have NCFB diagnosed by a physician and confirmed by CT (measured at screening; if a new CT is not possible, a CT performed within 12 months of the screening visit is acceptable).
- Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.
- If receiving prophylactic systemic or inhaled antibiotics to prevent bronchiectasis exacerbations, the dose/regimen must be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study. If prophylactic macrolides have been recently discontinued, patients must have been off treatment for at least 3 months prior to randomisation. In all other cases of prophylactic antibiotic use, ≥ 4 weeks wash out period should be in place after the last dose of antibiotic and prior to randomisation
- Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The dose and regimen of these therapies and any drugs used to aid expectoration should be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study.
Key exclusion criteria (30 listed)
- Pulmonary disease other than bronchiectasis. Patients with a history of NTM disease may be enrolled if they have completed treatment prior to the Screening visit, if at least 3 months have elapsed since the last day of antibiotic treatment for NTM at the Screening visit, and if they have had a negative sputum culture prior to the screening visit.
- Another diagnosed or suspected pulmonary or systemic disease associated with elevated peripheral eosinophil counts
- Respiratory infection or bronchiectasis exacerbation during the screening period.
- Any other clinical condition that is not stable in the opinion of the Investigator and could:
- Radiological findings suggestive of a respiratory disease other than bronchiectasis, suggestive of acute infection, or of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care. Pulmonary nodules > 6 mm in size should have at least 2 years of follow up with no change on CT imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabBenralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume | Biological | Benralizumab |
| Placebo to BenralizumabMatching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume | Biological | Placebo |
Primary outcome
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
12 secondary outcomes
Time to First Exacerbation in the Double-blind Treatment Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in LCQ Total Score Over the Double-blind Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MAHALE Poster Master USLink provided by the sponsor.
- 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.
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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.
James D. Chalmers, MD principal investigator
University of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK
48 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Non-cystic Fibrosis Bronchiectasis, run by AstraZeneca at 48 sites in 16 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 30 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: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, China, Denmark, Germany, Italy and 11 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period (time frame: through Double-blind period, at least 28 weeks and up to 52 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 20 Jul 2025.