Asthma
Conditions
Keywords
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Brief summary
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.
Interventions
BIOLOGICALBenralizumab
Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive. Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.
BIOLOGICALPlacebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
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 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures 2. Female and male aged from 18 to 75 years, inclusively 3. History of physician-diagnosed asthma requiring treatment with medium dose ICS (\>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1 4. Documented treatment with medium-dose ICS (\>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1
Exclusion criteria
1. Clinically important pulmonary disease other than asthma (e.g. 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 (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) 2. 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 - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study 3. 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 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Exacerbations Over 48 Weeks Treatment | 48 weeks treatment | The number of asthma exacerbations over 48 weeks treatment will be counted |
Countries
Argentina, Brazil, Bulgaria, Germany, Poland, Russia, United States
Participant flow
Recruitment details
The study was stopped with 13 patients randomised
Participants by arm
| Arm | Count |
|---|---|
| Benra 30 mg q.4 Weeks Fixed 30 mg dose of benralizumab every 4 weeks. | 3 |
| Benra 30 Mg-Placebo q.8 Weeks Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind). | 5 |
| Placebo A (Dummy) injection | 5 |
| Total | 13 |
Baseline characteristics
| Characteristic | Benra 30 mg q.4 Weeks | Benra 30 Mg-Placebo q.8 Weeks | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 15.7 | 57.8 years STANDARD_DEVIATION 6.38 | 49.6 years STANDARD_DEVIATION 6.35 | 54.8 years STANDARD_DEVIATION 9.32 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Asthma Exacerbations Over 48 Weeks Treatment
The number of asthma exacerbations over 48 weeks treatment will be counted
Time frame: 48 weeks treatment
Population: Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benra 30 mg q.4 Weeks | Asthma Exacerbations Over 48 Weeks Treatment | 0 Number of events |
| Benra 30 Mg-Placebo q.8 Weeks | Asthma Exacerbations Over 48 Weeks Treatment | 0 Number of events |
| Placebo | Asthma Exacerbations Over 48 Weeks Treatment | 0 Number of events |