Non-cystic Fibrosis Bronchiectasis
Conditions
Keywords
Benralizumab, Non-cystic Fibrosis Bronchiectasis, Eosinophlic Inflammation
Brief 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 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).
Interventions
BIOLOGICALBenralizumab
Benralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
BIOLOGICALPlacebo to Benralizumab
Matching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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: 1. Affect the safety of the patient during the study. 2. Influence the findings of the study or their interpretation. 3. 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: 1. 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 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period |
| Change From Baseline in LCQ Total Score Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Time to First Exacerbation in the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Time to first NCFB exacerbation in the double-blind treatment period |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
| Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | 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. |
Countries
Argentina, Australia, Canada, China, Denmark, Germany, India, Italy, Philippines, Poland, Russia, South Korea, Spain, United Kingdom, United States, Vietnam
Participant flow
Recruitment details
The plan was to randomize 420 eligible patients in a 1:1 ratio to receive either benralizumab or a matching placebo after screening. Patients were stratified at randomization by screening blood eosinophil category, country, and current chronic macrolide use. Due to the decision to stop recruitment early, 100 patients were randomized to receive benralizumab or placebo (20:80 in the low & high blood eosinophil strata). The revised DB treatment period was at least 28 weeks and up to 52 weeks.
Pre-assignment details
All patients completed a screening period of 2 to 6 weeks during which inclusion/exclusion criteria was assessed, disease activity, lung function and patient reported outcomes (PROs) were recorded, medical history and clinical laboratory were taken.
Participants by arm
| Arm | Count |
|---|---|
| Benralizumab 30 mg Benralizumab 30 mg injection delivered subcutaneously every 4 weeks | 54 |
| Placebo Matching placebo injection delivered subcutaneously every 4 weeks | 45 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Treatment Period | Physician Decision | 2 | 0 |
| Double-blind Treatment Period | Protocol Violation | 2 | 0 |
| Double-blind Treatment Period | Study terminated by sponsor | 1 | 0 |
| Double-blind Treatment Period | Subject decision without consent withdrawn | 0 | 1 |
| Double-blind Treatment Period | Withdrawal by Subject | 7 | 2 |
| Open-label Extension Period | Subject decision without consent withdrawn | 0 | 1 |
Baseline characteristics
| Characteristic | Benralizumab 30 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.14 | 59.2 years STANDARD_DEVIATION 15.49 | 59.2 years STANDARD_DEVIATION 14.18 |
| Age, Customized >= 18 to <= 65 years | 34 participants | 21 participants | 55 participants |
| Age, Customized > 65 years | 20 participants | 24 participants | 44 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 38 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 14 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 31 Participants | 67 Participants |
| Sex: Female, Male Female | 37 Participants | 35 Participants | 72 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 45 | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 33 / 54 | 18 / 45 | 9 / 38 | 9 / 40 |
| serious Total, serious adverse events | 10 / 54 | 3 / 45 | 5 / 38 | 4 / 40 |
Outcome results
Primary
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Benralizumab 30 mg | Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | 1.44 exacerbations per year |
| Placebo | Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | 1.27 exacerbations per year |
p-value: 0.591195% CI: [0.71, 1.82]negative binomial model
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 12 | 1.0 score on a scale | Standard Deviation 2.51 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 4 | 0.7 score on a scale | Standard Deviation 2.35 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 6 | 0.8 score on a scale | Standard Deviation 2.76 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 28 | 0.5 score on a scale | Standard Deviation 4.31 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 2 | 0.5 score on a scale | Standard Deviation 2.22 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 8 | 0.8 score on a scale | Standard Deviation 3.37 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 10 | 1.0 score on a scale | Standard Deviation 2.77 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 14 | 1.4 score on a scale | Standard Deviation 2.78 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 16 | 0.9 score on a scale | Standard Deviation 2.61 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 18 | 1.0 score on a scale | Standard Deviation 3.42 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 20 | 1.4 score on a scale | Standard Deviation 3.28 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 22 | 0.9 score on a scale | Standard Deviation 3.32 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 24 | 1.0 score on a scale | Standard Deviation 3.43 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 26 | 0.9 score on a scale | Standard Deviation 3.58 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 30 | 0.7 score on a scale | Standard Deviation 3.33 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 32 | 1.8 score on a scale | Standard Deviation 3.45 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 34 | 0.8 score on a scale | Standard Deviation 2.43 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 36 | 1.2 score on a scale | Standard Deviation 3.48 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 38 | 1.0 score on a scale | Standard Deviation 3.61 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 40 | 1.2 score on a scale | Standard Deviation 3.93 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 42 | 0.6 score on a scale | Standard Deviation 3.42 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 44 | 0.5 score on a scale | Standard Deviation 3.23 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 46 | 0.7 score on a scale | Standard Deviation 3.68 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 48 | 0.3 score on a scale | Standard Deviation 3.78 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 50 | 0.7 score on a scale | Standard Deviation 3.29 |
| Benralizumab 30 mg | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 52 | 0.2 score on a scale | Standard Deviation 3.94 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 40 | 0.2 score on a scale | Standard Deviation 3.86 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 26 | 1.0 score on a scale | Standard Deviation 3.54 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 50 | -0.2 score on a scale | Standard Deviation 3.41 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 6 | 0.6 score on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 30 | 0.8 score on a scale | Standard Deviation 4.06 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 28 | 0.9 score on a scale | Standard Deviation 4.08 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 42 | 0.3 score on a scale | Standard Deviation 4.19 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 4 | 0.0 score on a scale | Standard Deviation 2.15 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 32 | 0.7 score on a scale | Standard Deviation 4.14 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 8 | 0.3 score on a scale | Standard Deviation 2.85 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 48 | 0.5 score on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 10 | 0.1 score on a scale | Standard Deviation 2.76 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 2 | 0.5 score on a scale | Standard Deviation 2.13 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 12 | 0.4 score on a scale | Standard Deviation 3.03 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 34 | 0.8 score on a scale | Standard Deviation 3.92 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 14 | 0.8 score on a scale | Standard Deviation 3.16 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 44 | 0.3 score on a scale | Standard Deviation 4.02 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 16 | 0.5 score on a scale | Standard Deviation 3.1 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 36 | 0.8 score on a scale | Standard Deviation 3.95 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 18 | 1.1 score on a scale | Standard Deviation 3.55 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 52 | -0.1 score on a scale | Standard Deviation 2.86 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 20 | 0.8 score on a scale | Standard Deviation 3.39 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 38 | 0.6 score on a scale | Standard Deviation 4.24 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 22 | 0.8 score on a scale | Standard Deviation 4.03 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 46 | 0.6 score on a scale | Standard Deviation 4.22 |
| Placebo | Change From Baseline in LCQ Total Score Over the Double-blind Period | Week 24 | 1.2 score on a scale | Standard Deviation 3.48 |
Secondary
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
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 24 | -0.0378 L | Standard Deviation 0.1729 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 8 | 0.0048 L | Standard Deviation 0.15392 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 32 | -0.0248 L | Standard Deviation 0.16782 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 4 | 0.0139 L | Standard Deviation 0.14327 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 48 | -0.1236 L | Standard Deviation 0.16353 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 16 | -0.0191 L | Standard Deviation 0.15964 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 52 | -0.1093 L | Standard Deviation 0.1313 |
| Benralizumab 30 mg | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 40 | -0.0597 L | Standard Deviation 0.18924 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 52 | -0.1186 L | Standard Deviation 0.14969 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 4 | -0.0477 L | Standard Deviation 0.10758 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 8 | -0.0465 L | Standard Deviation 0.15263 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 16 | -0.0282 L | Standard Deviation 0.11452 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 24 | -0.0595 L | Standard Deviation 0.16409 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 40 | -0.1037 L | Standard Deviation 0.16808 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 48 | -0.0849 L | Standard Deviation 0.13783 |
| Placebo | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | Week 32 | -0.0921 L | Standard Deviation 0.17543 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 10 | 5.3 score on a scale | Standard Deviation 13.02 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 50 | 9.8 score on a scale | Standard Deviation 14.63 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 2 | 6.6 score on a scale | Standard Deviation 12.57 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 4 | 5.8 score on a scale | Standard Deviation 12.53 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 6 | 6.8 score on a scale | Standard Deviation 14.39 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 8 | 6.6 score on a scale | Standard Deviation 14.17 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 38 | 8.1 score on a scale | Standard Deviation 14.96 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 12 | 7.2 score on a scale | Standard Deviation 11.47 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 14 | 8.0 score on a scale | Standard Deviation 12.28 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 16 | 6.2 score on a scale | Standard Deviation 14.51 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 18 | 8.6 score on a scale | Standard Deviation 14.41 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 20 | 8.6 score on a scale | Standard Deviation 15.41 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 22 | 8.4 score on a scale | Standard Deviation 13.3 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 24 | 9.3 score on a scale | Standard Deviation 17.31 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 26 | 7.4 score on a scale | Standard Deviation 15.07 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 28 | 6.5 score on a scale | Standard Deviation 15.92 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 30 | 7.5 score on a scale | Standard Deviation 14.26 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 32 | 12.1 score on a scale | Standard Deviation 14.37 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 34 | 7.6 score on a scale | Standard Deviation 12.58 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 36 | 9.6 score on a scale | Standard Deviation 17.44 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 40 | 9.6 score on a scale | Standard Deviation 17.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 42 | 7.1 score on a scale | Standard Deviation 14.93 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 44 | 7.5 score on a scale | Standard Deviation 15 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 46 | 8.6 score on a scale | Standard Deviation 17.76 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 48 | 8.1 score on a scale | Standard Deviation 16.75 |
| Benralizumab 30 mg | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 52 | 7.3 score on a scale | Standard Deviation 17.91 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 36 | 3.6 score on a scale | Standard Deviation 19.31 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 38 | 1.3 score on a scale | Standard Deviation 17.68 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 24 | 4.4 score on a scale | Standard Deviation 17.7 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 50 | 0.1 score on a scale | Standard Deviation 15.42 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 48 | 3.2 score on a scale | Standard Deviation 20.52 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 2 | 3.1 score on a scale | Standard Deviation 11.65 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 26 | 3.8 score on a scale | Standard Deviation 18.4 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 4 | -1.5 score on a scale | Standard Deviation 12.49 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 40 | -1.1 score on a scale | Standard Deviation 18.5 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 6 | 0.7 score on a scale | Standard Deviation 10.94 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 28 | 2.7 score on a scale | Standard Deviation 21.33 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 8 | 2.1 score on a scale | Standard Deviation 16.29 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 46 | 3.4 score on a scale | Standard Deviation 18.89 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 10 | -1.0 score on a scale | Standard Deviation 14.46 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 30 | 1.2 score on a scale | Standard Deviation 17.32 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 12 | 0.9 score on a scale | Standard Deviation 15.44 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 42 | 3.3 score on a scale | Standard Deviation 16.25 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 14 | 3.7 score on a scale | Standard Deviation 14.63 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 32 | 2.4 score on a scale | Standard Deviation 19.09 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 16 | 1.3 score on a scale | Standard Deviation 15.79 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 52 | 0.2 score on a scale | Standard Deviation 18.12 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 18 | 2.6 score on a scale | Standard Deviation 18.6 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 34 | 2.8 score on a scale | Standard Deviation 18.9 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 20 | 1.4 score on a scale | Standard Deviation 18.58 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 44 | 0.8 score on a scale | Standard Deviation 20.76 |
| Placebo | Change From Baseline in QoL-B-RSS Over the Double-blind Period | Week 22 | 3.9 score on a scale | Standard Deviation 20.33 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 22 | 2.8 score on a scale | Standard Deviation 18.46 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 4 | -0.7 score on a scale | Standard Deviation 14.07 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 24 | 2.4 score on a scale | Standard Deviation 17.8 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 44 | 1.9 score on a scale | Standard Deviation 25.89 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 26 | 3.0 score on a scale | Standard Deviation 17.15 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 6 | 3.5 score on a scale | Standard Deviation 17.99 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 28 | 0.4 score on a scale | Standard Deviation 25.82 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 16 | 2.2 score on a scale | Standard Deviation 16.56 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 30 | 2.7 score on a scale | Standard Deviation 22.55 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 10 | 0.2 score on a scale | Standard Deviation 16.43 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 32 | 4.0 score on a scale | Standard Deviation 15.82 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 46 | 3.9 score on a scale | Standard Deviation 22.02 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 34 | 1.4 score on a scale | Standard Deviation 19.64 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 12 | 2.8 score on a scale | Standard Deviation 17.3 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 8 | -1.2 score on a scale | Standard Deviation 16.84 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 38 | 2.6 score on a scale | Standard Deviation 20.79 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 14 | 4.7 score on a scale | Standard Deviation 14.31 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 40 | 1.7 score on a scale | Standard Deviation 23.35 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 48 | 5.8 score on a scale | Standard Deviation 22.1 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 42 | 1.1 score on a scale | Standard Deviation 21.97 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 18 | 3.2 score on a scale | Standard Deviation 15.57 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 2 | 0.2 score on a scale | Standard Deviation 13.63 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 50 | 5.5 score on a scale | Standard Deviation 20.69 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 20 | 3.9 score on a scale | Standard Deviation 15.82 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 52 | 6.0 score on a scale | Standard Deviation 26.3 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 36 | 1.9 score on a scale | Standard Deviation 17.89 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 52 | 0.9 score on a scale | Standard Deviation 24.98 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 16 | 1.2 score on a scale | Standard Deviation 22.48 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 44 | 1.8 score on a scale | Standard Deviation 18.95 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 46 | 6.8 score on a scale | Standard Deviation 22.77 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 2 | 2.0 score on a scale | Standard Deviation 17.43 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 4 | 1.4 score on a scale | Standard Deviation 14.42 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 8 | 1.4 score on a scale | Standard Deviation 17.77 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 10 | -1.0 score on a scale | Standard Deviation 16.58 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 12 | 1.6 score on a scale | Standard Deviation 21.38 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 14 | 1.8 score on a scale | Standard Deviation 20.79 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 18 | 3.8 score on a scale | Standard Deviation 21.68 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 20 | 1.4 score on a scale | Standard Deviation 22.27 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 22 | 2.1 score on a scale | Standard Deviation 23.09 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 24 | 2.9 score on a scale | Standard Deviation 19.32 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 26 | 4.3 score on a scale | Standard Deviation 22 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 28 | 1.6 score on a scale | Standard Deviation 24.43 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 30 | 1.5 score on a scale | Standard Deviation 23.79 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 32 | 3.0 score on a scale | Standard Deviation 22.42 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 34 | 1.9 score on a scale | Standard Deviation 23.23 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 36 | 4.5 score on a scale | Standard Deviation 22.75 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 38 | 1.9 score on a scale | Standard Deviation 22.64 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 40 | 2.3 score on a scale | Standard Deviation 22.28 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 42 | 3.4 score on a scale | Standard Deviation 22.67 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 48 | 5.4 score on a scale | Standard Deviation 22.83 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 50 | 3.0 score on a scale | Standard Deviation 18.14 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | Week 6 | 4.2 score on a scale | Standard Deviation 14.98 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 14 | 7.4 score on a scale | Standard Deviation 16.78 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 4 | 1.2 score on a scale | Standard Deviation 14.87 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 6 | 3.5 score on a scale | Standard Deviation 16.9 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 8 | 5.3 score on a scale | Standard Deviation 17.23 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 10 | 5.6 score on a scale | Standard Deviation 16.57 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 12 | 7.5 score on a scale | Standard Deviation 16.69 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 2 | 1.3 score on a scale | Standard Deviation 12.95 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 16 | 1.9 score on a scale | Standard Deviation 16.25 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 18 | 5.8 score on a scale | Standard Deviation 16.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 20 | 4.6 score on a scale | Standard Deviation 18.21 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 22 | 5.0 score on a scale | Standard Deviation 16.7 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 24 | 7.2 score on a scale | Standard Deviation 17.18 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 26 | 2.8 score on a scale | Standard Deviation 16.76 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 28 | 3.4 score on a scale | Standard Deviation 18.81 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 30 | 4.5 score on a scale | Standard Deviation 18.03 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 32 | 7.0 score on a scale | Standard Deviation 16.37 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 34 | 4.2 score on a scale | Standard Deviation 17.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 36 | 3.5 score on a scale | Standard Deviation 17.84 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 38 | 4.2 score on a scale | Standard Deviation 16.3 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 40 | 5.1 score on a scale | Standard Deviation 16.95 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 42 | 4.7 score on a scale | Standard Deviation 18.38 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 44 | 4.8 score on a scale | Standard Deviation 21.03 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 46 | 6.6 score on a scale | Standard Deviation 22.45 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 48 | 7.3 score on a scale | Standard Deviation 21.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 50 | 6.9 score on a scale | Standard Deviation 20.42 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 52 | 4.0 score on a scale | Standard Deviation 21.53 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 40 | 1.4 score on a scale | Standard Deviation 22.35 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 2 | 3.3 score on a scale | Standard Deviation 14.12 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 28 | 2.4 score on a scale | Standard Deviation 20.68 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 4 | -0.2 score on a scale | Standard Deviation 16.72 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 50 | 4.7 score on a scale | Standard Deviation 18.65 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 6 | 3.7 score on a scale | Standard Deviation 16.06 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 30 | 4.3 score on a scale | Standard Deviation 21.87 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 8 | 4.3 score on a scale | Standard Deviation 18.46 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 42 | 4.4 score on a scale | Standard Deviation 23.77 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 10 | 2.1 score on a scale | Standard Deviation 18.47 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 32 | 2.4 score on a scale | Standard Deviation 20.09 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 12 | 3.3 score on a scale | Standard Deviation 17.74 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 48 | 3.9 score on a scale | Standard Deviation 23.68 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 14 | 1.4 score on a scale | Standard Deviation 18.99 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 34 | 2.9 score on a scale | Standard Deviation 22.29 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 16 | 2.4 score on a scale | Standard Deviation 20.35 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 44 | 1.5 score on a scale | Standard Deviation 20.78 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 18 | 1.7 score on a scale | Standard Deviation 20.69 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 36 | 2.0 score on a scale | Standard Deviation 20.56 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 20 | 3.9 score on a scale | Standard Deviation 21.7 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 52 | 0.4 score on a scale | Standard Deviation 24.13 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 22 | 6.3 score on a scale | Standard Deviation 21.99 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 38 | 3.0 score on a scale | Standard Deviation 22.9 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 24 | 5.0 score on a scale | Standard Deviation 19.85 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 46 | 1.8 score on a scale | Standard Deviation 19.07 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale | Week 26 | 5.0 score on a scale | Standard Deviation 20.26 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 10 | 1.5 score on a scale | Standard Deviation 19.22 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 26 | 3.6 score on a scale | Standard Deviation 20.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 44 | 0.6 score on a scale | Standard Deviation 23.62 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 52 | 5.1 score on a scale | Standard Deviation 23.9 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 4 | 1.5 score on a scale | Standard Deviation 17.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 6 | 4.1 score on a scale | Standard Deviation 20.81 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 8 | 3.3 score on a scale | Standard Deviation 15.07 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 2 | 0.5 score on a scale | Standard Deviation 12.23 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 12 | 3.1 score on a scale | Standard Deviation 19.54 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 14 | 4.4 score on a scale | Standard Deviation 15.48 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 16 | 3.5 score on a scale | Standard Deviation 18.06 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 18 | 4.8 score on a scale | Standard Deviation 19.15 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 20 | 4.5 score on a scale | Standard Deviation 18.45 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 22 | 3.1 score on a scale | Standard Deviation 19.62 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 24 | 5.2 score on a scale | Standard Deviation 18.21 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 28 | 3.8 score on a scale | Standard Deviation 24.77 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 30 | 2.5 score on a scale | Standard Deviation 21.33 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 32 | 6.7 score on a scale | Standard Deviation 18.8 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 34 | 2.7 score on a scale | Standard Deviation 19.14 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 36 | 0.6 score on a scale | Standard Deviation 22.76 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 38 | 1.9 score on a scale | Standard Deviation 16.4 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 40 | 2.1 score on a scale | Standard Deviation 23.55 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 42 | 1.3 score on a scale | Standard Deviation 21.13 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 46 | 2.0 score on a scale | Standard Deviation 22.89 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 48 | 0.0 score on a scale | Standard Deviation 27.89 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 50 | 5.3 score on a scale | Standard Deviation 23.46 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 50 | 1.3 score on a scale | Standard Deviation 21.08 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 24 | 4.7 score on a scale | Standard Deviation 23.03 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 26 | 3.6 score on a scale | Standard Deviation 24.4 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 40 | 4.1 score on a scale | Standard Deviation 25.01 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 28 | 4.8 score on a scale | Standard Deviation 24.39 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 2 | -0.0 score on a scale | Standard Deviation 16.5 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 48 | 7.6 score on a scale | Standard Deviation 22.98 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 4 | 0.8 score on a scale | Standard Deviation 19.39 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 30 | 4.8 score on a scale | Standard Deviation 25.5 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 6 | 0.2 score on a scale | Standard Deviation 17.97 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 42 | 5.5 score on a scale | Standard Deviation 28.92 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 8 | 0.3 score on a scale | Standard Deviation 20.81 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 32 | 5.9 score on a scale | Standard Deviation 24.73 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 10 | 1.0 score on a scale | Standard Deviation 22.06 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 44 | 4.2 score on a scale | Standard Deviation 24.03 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 12 | 0.5 score on a scale | Standard Deviation 21.89 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 34 | 3.5 score on a scale | Standard Deviation 24.9 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 14 | 4.2 score on a scale | Standard Deviation 22.15 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 52 | 2.1 score on a scale | Standard Deviation 19.25 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 16 | 3.3 score on a scale | Standard Deviation 25.17 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 36 | 4.7 score on a scale | Standard Deviation 24.78 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 18 | 2.2 score on a scale | Standard Deviation 23.01 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 46 | 7.9 score on a scale | Standard Deviation 23.42 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 20 | 4.7 score on a scale | Standard Deviation 25.18 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 38 | 3.5 score on a scale | Standard Deviation 23.5 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | Week 22 | 2.2 score on a scale | Standard Deviation 22.96 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 10 | 1.2 score on a scale | Standard Deviation 14.09 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 20 | 0.9 score on a scale | Standard Deviation 16.01 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 2 | 1.1 score on a scale | Standard Deviation 13.64 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 4 | 2.8 score on a scale | Standard Deviation 13 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 6 | 2.7 score on a scale | Standard Deviation 14.8 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 8 | 0.5 score on a scale | Standard Deviation 16.27 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 12 | 1.7 score on a scale | Standard Deviation 16.36 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 14 | 3.0 score on a scale | Standard Deviation 16.1 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 16 | 0.1 score on a scale | Standard Deviation 17.77 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 18 | 2.4 score on a scale | Standard Deviation 16.93 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 22 | 2.8 score on a scale | Standard Deviation 21.11 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 24 | 1.9 score on a scale | Standard Deviation 22.6 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 26 | -0.1 score on a scale | Standard Deviation 21.44 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 28 | -1.9 score on a scale | Standard Deviation 21.02 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 30 | 1.1 score on a scale | Standard Deviation 20.83 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 32 | 4.4 score on a scale | Standard Deviation 15.08 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 34 | 1.4 score on a scale | Standard Deviation 18.01 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 36 | -0.6 score on a scale | Standard Deviation 19.18 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 38 | 1.4 score on a scale | Standard Deviation 18.15 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 40 | 1.7 score on a scale | Standard Deviation 22.2 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 42 | -1.3 score on a scale | Standard Deviation 21.48 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 44 | 0.6 score on a scale | Standard Deviation 25.33 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 46 | 0.4 score on a scale | Standard Deviation 23.89 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 48 | -1.2 score on a scale | Standard Deviation 25.03 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 50 | 0.7 score on a scale | Standard Deviation 21.26 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 52 | -0.8 score on a scale | Standard Deviation 23.28 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 38 | -2.2 score on a scale | Standard Deviation 19.65 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 8 | 0.2 score on a scale | Standard Deviation 15.02 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 26 | 1.2 score on a scale | Standard Deviation 18.36 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 20 | 0.5 score on a scale | Standard Deviation 18.25 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 28 | 2.7 score on a scale | Standard Deviation 17.79 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 42 | 1.8 score on a scale | Standard Deviation 20.19 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 46 | 4.0 score on a scale | Standard Deviation 19 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 2 | -1.2 score on a scale | Standard Deviation 11.11 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 40 | 0.2 score on a scale | Standard Deviation 21.8 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 4 | -0.3 score on a scale | Standard Deviation 14.53 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 30 | -0.3 score on a scale | Standard Deviation 19.04 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 6 | 2.5 score on a scale | Standard Deviation 12.05 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 50 | -1.9 score on a scale | Standard Deviation 12.55 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 10 | 2.7 score on a scale | Standard Deviation 16.32 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 32 | 0.2 score on a scale | Standard Deviation 18.17 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 12 | 2.3 score on a scale | Standard Deviation 16.96 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 48 | 0.2 score on a scale | Standard Deviation 18.16 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 14 | 2.1 score on a scale | Standard Deviation 16.7 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 34 | 1.7 score on a scale | Standard Deviation 17.97 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 16 | -0.3 score on a scale | Standard Deviation 16.6 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 44 | -1.4 score on a scale | Standard Deviation 17.46 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 18 | -0.0 score on a scale | Standard Deviation 17.67 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 36 | 0.5 score on a scale | Standard Deviation 16.69 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 22 | 4.0 score on a scale | Standard Deviation 20.47 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 52 | 1.1 score on a scale | Standard Deviation 17.81 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | Week 24 | 0.6 score on a scale | Standard Deviation 19.67 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 50 | 10.2 score on a scale | Standard Deviation 23.6 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 20 | 11.8 score on a scale | Standard Deviation 22.59 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 28 | 8.8 score on a scale | Standard Deviation 24.67 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 44 | 9.9 score on a scale | Standard Deviation 28.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 52 | 11.6 score on a scale | Standard Deviation 27.91 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 2 | 6.4 score on a scale | Standard Deviation 17.6 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 4 | 4.4 score on a scale | Standard Deviation 18.62 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 6 | 8.4 score on a scale | Standard Deviation 21.6 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 10 | 9.4 score on a scale | Standard Deviation 19.64 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 12 | 10.6 score on a scale | Standard Deviation 23.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 14 | 10.9 score on a scale | Standard Deviation 23.03 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 16 | 9.1 score on a scale | Standard Deviation 20.73 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 18 | 11.6 score on a scale | Standard Deviation 21.61 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 22 | 7.2 score on a scale | Standard Deviation 20.42 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 24 | 10.1 score on a scale | Standard Deviation 24.9 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 26 | 10.1 score on a scale | Standard Deviation 22.86 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 30 | 10.2 score on a scale | Standard Deviation 26.57 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 32 | 12.8 score on a scale | Standard Deviation 23.84 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 34 | 9.6 score on a scale | Standard Deviation 27.93 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 36 | 12.0 score on a scale | Standard Deviation 27.06 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 38 | 10.2 score on a scale | Standard Deviation 27.83 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 40 | 13.9 score on a scale | Standard Deviation 32.35 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 42 | 10.2 score on a scale | Standard Deviation 29.4 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 46 | 9.1 score on a scale | Standard Deviation 27.4 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 48 | 12.1 score on a scale | Standard Deviation 27.11 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 8 | 9.7 score on a scale | Standard Deviation 23.1 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 46 | 6.6 score on a scale | Standard Deviation 29.11 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 8 | 9.2 score on a scale | Standard Deviation 20.53 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 16 | 6.0 score on a scale | Standard Deviation 23.53 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 22 | 9.5 score on a scale | Standard Deviation 24.09 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 36 | 8.1 score on a scale | Standard Deviation 25.53 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 24 | 10.7 score on a scale | Standard Deviation 24.14 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 44 | 1.8 score on a scale | Standard Deviation 24.5 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 50 | -1.7 score on a scale | Standard Deviation 26.85 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 42 | 8.6 score on a scale | Standard Deviation 28.16 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 52 | 2.3 score on a scale | Standard Deviation 25.29 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 26 | 9.9 score on a scale | Standard Deviation 22.46 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 2 | 4.5 score on a scale | Standard Deviation 17.35 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 28 | 8.7 score on a scale | Standard Deviation 24.83 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 4 | 6.3 score on a scale | Standard Deviation 22.69 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 38 | 6.5 score on a scale | Standard Deviation 25.41 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 6 | 5.8 score on a scale | Standard Deviation 20.05 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 30 | 7.7 score on a scale | Standard Deviation 24.82 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 10 | 6.0 score on a scale | Standard Deviation 20.31 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 48 | 3.9 score on a scale | Standard Deviation 30.74 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 12 | 5.8 score on a scale | Standard Deviation 21.42 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 32 | 8.6 score on a scale | Standard Deviation 24.48 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 14 | 7.7 score on a scale | Standard Deviation 20.52 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 40 | 8.3 score on a scale | Standard Deviation 27.77 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 34 | 9.3 score on a scale | Standard Deviation 24.95 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 18 | 10.3 score on a scale | Standard Deviation 22.43 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | Week 20 | 8.9 score on a scale | Standard Deviation 21.43 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 36 | -0.7 score on a scale | Standard Deviation 16.68 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 38 | -4.2 score on a scale | Standard Deviation 25.27 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 40 | -2.0 score on a scale | Standard Deviation 24.76 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 42 | -1.5 score on a scale | Standard Deviation 23.52 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 44 | 2.1 score on a scale | Standard Deviation 17.22 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 46 | -0.0 score on a scale | Standard Deviation 18.59 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 48 | -0.9 score on a scale | Standard Deviation 17.25 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 50 | -2.0 score on a scale | Standard Deviation 22.13 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 52 | -1.9 score on a scale | Standard Deviation 25.64 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 2 | 3.6 score on a scale | Standard Deviation 22.56 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 4 | 3.7 score on a scale | Standard Deviation 18.62 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 6 | 6.0 score on a scale | Standard Deviation 23.2 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 8 | 4.8 score on a scale | Standard Deviation 18.35 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 10 | 4.0 score on a scale | Standard Deviation 17.31 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 12 | 0.3 score on a scale | Standard Deviation 17.27 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 14 | 0.6 score on a scale | Standard Deviation 20.74 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 16 | 4.4 score on a scale | Standard Deviation 20.1 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 20 | 4.1 score on a scale | Standard Deviation 16.01 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 22 | -1.3 score on a scale | Standard Deviation 14.37 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 24 | -1.0 score on a scale | Standard Deviation 18.58 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 26 | 1.9 score on a scale | Standard Deviation 17.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 28 | -5.1 score on a scale | Standard Deviation 24 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 30 | -2.0 score on a scale | Standard Deviation 19.14 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 32 | -2.1 score on a scale | Standard Deviation 16.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 34 | -0.4 score on a scale | Standard Deviation 16.7 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 18 | -1.9 score on a scale | Standard Deviation 16.28 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 32 | -0.8 score on a scale | Standard Deviation 15.12 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 36 | -1.5 score on a scale | Standard Deviation 16.69 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 10 | 1.1 score on a scale | Standard Deviation 17.83 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 38 | -2.9 score on a scale | Standard Deviation 21.04 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 24 | -1.1 score on a scale | Standard Deviation 14.45 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 40 | -0.4 score on a scale | Standard Deviation 16.15 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 12 | -0.4 score on a scale | Standard Deviation 12.54 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 42 | 1.7 score on a scale | Standard Deviation 18.78 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 30 | -1.1 score on a scale | Standard Deviation 18.39 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 44 | 1.4 score on a scale | Standard Deviation 21 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 14 | -4.1 score on a scale | Standard Deviation 14.73 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 46 | 4.6 score on a scale | Standard Deviation 14.62 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 26 | 2.5 score on a scale | Standard Deviation 15.37 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 48 | 3.6 score on a scale | Standard Deviation 19.96 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 16 | -1.1 score on a scale | Standard Deviation 16.34 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 50 | -1.9 score on a scale | Standard Deviation 18.77 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 18 | -1.2 score on a scale | Standard Deviation 14.92 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 52 | 1.7 score on a scale | Standard Deviation 14.94 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 34 | -4.0 score on a scale | Standard Deviation 17.95 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 2 | -2.2 score on a scale | Standard Deviation 16.75 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 20 | 0.3 score on a scale | Standard Deviation 15.84 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 4 | -2.1 score on a scale | Standard Deviation 13.34 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 28 | 1.4 score on a scale | Standard Deviation 15.11 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 6 | -2.1 score on a scale | Standard Deviation 15.72 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 22 | -0.8 score on a scale | Standard Deviation 16.82 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale | Week 8 | -1.9 score on a scale | Standard Deviation 14.87 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 40 | 2.6 score on a scale | Standard Deviation 23.01 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 24 | 4.1 score on a scale | Standard Deviation 20.87 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 10 | 6.4 score on a scale | Standard Deviation 16.32 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 26 | 6.2 score on a scale | Standard Deviation 20.18 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 4 | 3.1 score on a scale | Standard Deviation 17.82 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 28 | 3.9 score on a scale | Standard Deviation 21.75 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 2 | 3.0 score on a scale | Standard Deviation 18.77 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 30 | 4.4 score on a scale | Standard Deviation 21.84 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 12 | 5.8 score on a scale | Standard Deviation 18.48 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 32 | 6.1 score on a scale | Standard Deviation 19.97 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 38 | 4.1 score on a scale | Standard Deviation 18.88 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 34 | 1.1 score on a scale | Standard Deviation 18.98 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 14 | 8.8 score on a scale | Standard Deviation 20.69 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 36 | 1.0 score on a scale | Standard Deviation 18.59 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 6 | 4.0 score on a scale | Standard Deviation 18.83 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 42 | 3.0 score on a scale | Standard Deviation 21.54 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 16 | 5.2 score on a scale | Standard Deviation 19.66 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 44 | 2.9 score on a scale | Standard Deviation 21.11 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 18 | 5.0 score on a scale | Standard Deviation 19.78 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 46 | 5.2 score on a scale | Standard Deviation 24.65 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 8 | 4.9 score on a scale | Standard Deviation 17.84 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 48 | 2.0 score on a scale | Standard Deviation 23.48 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 50 | 7.7 score on a scale | Standard Deviation 20.81 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 20 | 7.1 score on a scale | Standard Deviation 19.99 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 52 | 5.3 score on a scale | Standard Deviation 18.74 |
| Benralizumab 30 mg | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 22 | 5.7 score on a scale | Standard Deviation 21.66 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 28 | -2.1 score on a scale | Standard Deviation 21.57 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 20 | -1.3 score on a scale | Standard Deviation 19.28 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 38 | -0.0 score on a scale | Standard Deviation 19.52 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 40 | -2.7 score on a scale | Standard Deviation 21.97 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 48 | -1.3 score on a scale | Standard Deviation 20.97 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 2 | -2.4 score on a scale | Standard Deviation 13.54 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 4 | 0.3 score on a scale | Standard Deviation 15.21 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 6 | -2.0 score on a scale | Standard Deviation 13.88 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 8 | -1.1 score on a scale | Standard Deviation 16.26 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 10 | -3.1 score on a scale | Standard Deviation 18.83 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 12 | -3.9 score on a scale | Standard Deviation 16.24 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 14 | -2.7 score on a scale | Standard Deviation 18.22 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 16 | -0.5 score on a scale | Standard Deviation 19.71 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 18 | -1.4 score on a scale | Standard Deviation 18.69 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 22 | -0.6 score on a scale | Standard Deviation 21.04 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 24 | 1.0 score on a scale | Standard Deviation 19.67 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 26 | -1.6 score on a scale | Standard Deviation 20.66 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 30 | -4.3 score on a scale | Standard Deviation 22.74 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 32 | 0.0 score on a scale | Standard Deviation 20.49 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 34 | -0.8 score on a scale | Standard Deviation 20.96 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 36 | -2.7 score on a scale | Standard Deviation 18.72 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 42 | -1.0 score on a scale | Standard Deviation 24.37 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 44 | -3.4 score on a scale | Standard Deviation 21.24 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 46 | 1.0 score on a scale | Standard Deviation 20.1 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 50 | 0.0 score on a scale | Standard Deviation 18.14 |
| Placebo | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | Week 52 | -5.3 score on a scale | Standard Deviation 23.53 |
Secondary
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.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 4 | -4.7 score on a scale | Standard Deviation 14.92 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 8 | -4.3 score on a scale | Standard Deviation 15.99 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 16 | -4.4 score on a scale | Standard Deviation 15.03 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 24 | -6.3 score on a scale | Standard Deviation 16.21 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 32 | -5.8 score on a scale | Standard Deviation 15.73 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 40 | -5.8 score on a scale | Standard Deviation 17.63 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 48 | -4.9 score on a scale | Standard Deviation 18.58 |
| Benralizumab 30 mg | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 52 | -4.4 score on a scale | Standard Deviation 20.37 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 52 | 4.8 score on a scale | Standard Deviation 23.33 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 4 | 0.6 score on a scale | Standard Deviation 14.89 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 32 | -1.6 score on a scale | Standard Deviation 21.46 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 8 | -2.4 score on a scale | Standard Deviation 15.33 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 48 | -0.0 score on a scale | Standard Deviation 22.45 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 16 | -0.1 score on a scale | Standard Deviation 16.06 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 40 | -1.6 score on a scale | Standard Deviation 24.51 |
| Placebo | Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period | Week 24 | -3.9 score on a scale | Standard Deviation 21.08 |
Secondary
Time to First Exacerbation in the Double-blind Treatment Period
Time to first NCFB exacerbation in the double-blind treatment period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Benralizumab 30 mg | Time to First Exacerbation in the Double-blind Treatment Period | 233 days |
| Placebo | Time to First Exacerbation in the Double-blind Treatment Period | 316 days |
p-value: 0.667795% CI: [0.67, 1.91]Regression, Cox