AsthmaPhase 3SOLANANCT02869438
A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 54 sites in 6 countries.
Trial summary
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 54 sitesin 6 countries
- Study dates
- 9 Nov 2016to 1 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
- Female and male aged 18 to 75 years inclusively at the time of Visit 1
- Documented current treatment with ICS and LABA for at least 30 days prior to Visit 1. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. Additional asthma controller medications, eg, oral corticosteroids, long-acting antimuscarinics (LAMAs), LTRAs, theophylline etc. are allowed if they have been used for at least 30 days prior to Visit 1
- History of at least 2 asthma exacerbations that required treatment with systemic corticosteroids (intramuscular (IM), intravenous (IV), or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose.
- Pre-bronchodilator (pre-BD) FEV1 of < 80% predicted at Visit 2 or Visit 3
- ACQ-6 score ≥1.5 at Visit 1
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- Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1, Visit 2 or Visit 3. For patients entering the body plethysmography sub-study, reversibility must be demonstrated at Visit 1 or at Visit 2 only
- Peripheral blood eosinophil count of ≥300 cells/μL assessed by central lab at Visit 1
- Women of childbearing potential (WOCBP) must use an effective form of birth control confirmed by the Investigator. WOCBP must also have negative serum pregnancy test result on Visit 1.
- Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following agespecific requirements apply:
- Women <50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- Women ≥50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
- All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose
- Weight of ≥40 kg
- Additional inclusion criteria applicable for the Body Plethysmography substudy 1.Residual volume ≥125% of predicted at Visit 3.
- At least 1 of the following within 7 days prior to randomization:
- Daytime or nighttime asthma symptoms for 2 or more days;
- Rescue SABA use for 2 or more days;
- Nighttime awakenings due to asthma at least 1 night during the 7-day period
- ACQ >0.75 at Visit 4 prior to randomization.
- A negative urine pregnancy test in WOCBP prior to administration of IP
Who cannot join
- Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- Life-threatening asthma defined as episodes requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episodes within the 12 months prior to Visit 1.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- An upper respiratory tract infection or an asthma exacerbation that required treatment with systemic corticosteroids or an increase in regular maintenance dose of OCS during the screening/run-in period prior to randomization Visit 4
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
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- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to any biologic therapy
- History of Guillain-Barré syndrome
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
- Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
- Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments
- History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained
- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll
- A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- Current smokers or former smokers with a smoking history of ≥10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1
- Current malignancy, or history of malignancy, except for:
- Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
- Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
- Use of immunosuppressive medication (including but not limited to: oral corticosteroids [for reasons other than asthma], methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥1.5 times the upper limit of normal (ULN) confirmed during screening period
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
- Receipt of any marketed (eg, omalizumab, mepolizumab etc.) or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer
- Receipt of live attenuated vaccines 30 days prior to the date of randomization
- Receipt of any investigational medication within 30 days or 5 half-lives prior to randomization, whichever is longer
- Previously received benralizumab (MEDI-563)
- Planned surgical procedures during the conduct of the study
- Currently breastfeeding or lactating women
- Previous randomization in the present study
- Concurrent enrolment in another interventional or post-authorization safety study (PASS).
- AstraZeneca staff involved in the planning and/or conduct of the study
- Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
- 1. Greater than/equal to 20% change in mean Pre BD FEV1 value at randomization Visit 4 from the mean pre BD FEV1 calculated from the pre BD FEV1 recorded at Visit 2 and Visit 3
Trial locations and contacts
54 sites in 6 countries.
54 sites in 6 countries
United States16 sites
Research Site
Cincinnati, Ohio, 45231
Research Site
Denver, Colorado, 80206
Research Site
Fort Mitchell, Kentucky, 41017
Research Site
Gilbert, Arizona, 85234
Research Site
Lampasas, Texas, 76550
Research Site
McKinney, Texas, 75069
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33174
Research Site
New Bern, North Carolina, 28562
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Rochester, Minnesota, 55905
Research Site
Scottsboro, Alabama, 35768
Research Site
Tampa, Florida, 33607
Research Site
Vero Beach, Florida, 32960
Research Site
Winter Park, Florida, 32789
Germany12 sites
Research Site
Bamberg, 96049
Research Site
Darmstadt, 64283
Research Site
Frankfurt, 60596
Research Site
Frankfurt am Main, 60389
Research Site
Frankfurt am Main, 60596
Research Site
Hamburg, 20354
Research Site
Hamburg, 22299
Research Site
Hanover, 30167
Research Site
Hanover, 30625
Research Site
Hanover, D-30173
Research Site
Mainz, 55131
Research Site
München, 81377
Hungary9 sites
Research Site
Balassagyarmat, 2660
Research Site
Edelény, 3780
Research Site
Farkasgyepü, 8582
Research Site
Gödöllő, 2100
Research Site
Hajdúnánás, 4080
Research Site
Komárom, 2900
Research Site
Miskolc, 3529
Research Site
Pécs, 7626
Research Site
Pécs, 7635
South Korea9 sites
Research Site
Cheongju-si, 28644
Research Site
Daegu, 42415
Research Site
Jeonju, 54907
Research Site
Seoul, 03080
Research Site
Seoul, 03312
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Chile4 sites
Research Site
Curicó, 3341643
Research Site
Santiago, 404366
Research Site
Santiago, 7500692
Research Site
Santiago, 7750495
Philippines4 sites
Research Site
Iloilo City, 5000
Research Site
Lipa City
Research Site
Manila, 1000
Research Site
Quezon City, 0870
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
- Conditions
- Asthma
- Being tested
- Benralizumab, Placebo
- Keywords
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
- Medical subject headings
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Benralizumab administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)
PlaceboOther
Placebo administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab arm | Experimental | Benralizumab administered subcutaneously Receives: Drug: Benralizumab |
| Placebo arm | Placebo comparator | Placebo administered subcutaneously Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1
The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Measured: From first IP dose to Day 84
Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)
Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
Measured: From first IP dose to Day 84
Secondary outcomes (13)
Percent Change From Baseline to End of Treatment in Eosinophils Counts
Percent change from baseline to Day 84
Measured: From first IP dose to Day 84
Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1
Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. [Note: Day 28, 56, 84 are presented in the Primary measure.]
Measured: From first IP dose to Day 84
Change From Baseline to Post Baseline for Pre-BD FVC
Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84.
Measured: From first IP dose to Day 84
Percentage of Pre-BD FEV1 Responder
Pre-BD FEV1 responder is defined as change from baseline in FEV1 >=100 ml
Measured: From first IP dose to Day 84
Change From Baseline in ACQ-6
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Measured: From first IP dose to Day 84
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in FeNO
Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients
Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients
Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients
Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients
Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Measured: From first IP dose to Day 84
Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients
Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.
Measured: From first IP dose to Day 84
Duration of IP Administration
Duration of IP administration is last IP dose date - first IP dose +1.
Measured: From first IP to last IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start9 Nov 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reynold A Panettieri, Doctor of Medicine, Principal investigator, Child Health Institute of NJ, 89 French Street, Suite 4210, New Brunswick, NJ, 08901, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869438
- Sponsor's protocol ID
- D3250C00038
- Other IDs
- 2016-002094-36, U1111-1185-6625, 2016
- Acronym
- SOLANA
- Status last verified
- Oct 2019
- First submitted
- 16 Aug 2016
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
- ClinicalTrials.gov ID
- NCT02869438
- Acronym / sponsor ID
- SOLANA / D3250C00038
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab arm | Experimental | Drug: BenralizumabBenralizumab administered subcutaneously |
| Placebo arm | Placebo comparator | Other: PlaceboPlacebo administered subcutaneously |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
- Female and male aged 18 to 75 years inclusively at the time of Visit 1
- Documented current treatment with ICS and LABA for at least 30 days prior to Visit 1. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. Additional asthma controller medications, eg, oral corticosteroids, long-acting antimuscarinics (LAMAs), LTRAs, theophylline etc. are allowed if they have been used for at least 30 days prior to Visit 1
- History of at least 2 asthma exacerbations that required treatment with systemic corticosteroids (intramuscular (IM), intravenous (IV), or oral) in the 12 months prior to Visit 1. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of their maintenance dose.
- Pre-bronchodilator (pre-BD) FEV1 of < 80% predicted at Visit 2 or Visit 3
Key exclusion criteria (35 listed)
- Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- Life-threatening asthma defined as episodes requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episodes within the 12 months prior to Visit 1.
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- An upper respiratory tract infection or an asthma exacerbation that required treatment with systemic corticosteroids or an increase in regular maintenance dose of OCS during the screening/run-in period prior to randomization Visit 4
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabBenralizumab administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days) | Drug | Benralizumab arm |
| PlaceboPlacebo administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days) | Other | Placebo arm |
Primary outcome
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1
Time frame: From first IP dose to Day 84
The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)
Time frame: From first IP dose to Day 84
Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
13 secondary outcomes
Percent Change From Baseline to End of Treatment in Eosinophils Counts
Time frame: From first IP dose to Day 84
Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1
Time frame: From first IP dose to Day 84
Change From Baseline to Post Baseline for Pre-BD FVC
Time frame: From first IP dose to Day 84
Percentage of Pre-BD FEV1 Responder
Time frame: From first IP dose to Day 84
Change From Baseline in ACQ-6
Time frame: From first IP dose to Day 84
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in FeNO
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients
Time frame: From first IP dose to Day 84
Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients
Time frame: From first IP dose to Day 84
Duration of IP Administration
Time frame: From first IP to last IP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ProtocolLink provided by the sponsor.
- SAPLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reynold A Panettieri, Doctor of Medicine principal investigator
Child Health Institute of NJ, 89 French Street, Suite 4210, New Brunswick, NJ, 08901, USA
54 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 54 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Germany, Hungary, South Korea, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1 (time frame: From first IP dose to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.