None listed
Conditions
Interventions
Group 1 Type of group
EOS- (defined as ELEN Index negative and FeNO
EOS+ participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Age 18 through 75 years at the time of screening • Adequate contraception from screening through end of trial • Weight of more than (>) 45 kilogram (kg) but less than or equal to (100pound [lb] but <=330 lb) • History of physician-diagnosed asthma for at least 12 months prior to screening • Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening • Willingness to switch to an ICS/LABA combination product • Dose of other asthma controller medications must be stable for at least 30 days prior to screening • At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst • For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population • Ability and willingness to complete the study to Week 66, and if needed to Week 92.
Exclusion criteria
Exclusion criteria: • Known history of allergy or reaction to any component of the investigational product formulation • History of anaphylaxis to any biologic therapy • Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening • Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed • Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period • Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period • Receipt of immunoglobulin or blood products within 30 days prior to screening • Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer • Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer • Previously received MEDI-563 • Any clinically relevant abnormal findings in physical examination • Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality • Breastfeeding or lactating women • History of alcohol or drug abuse within 12 months prior to screening • History of any known primary immunodeficiency disorder • Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol • A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications • History of cigarette smoking more than or equal to (>=) 10 pack-years or smoking within 12 months prior to screening. • Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma • History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >=12 months prior to screening or other malignancies treated with apparent success with curative therapy >=5 years prior to screening • Stable dose of allergy vaccination regimen for less than 30 days prior to screening • Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1. Measure:Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants Timepoints:Week 1 up to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study. Measure:Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants Timepoints:Baseline up to Week 92 ; Outcome name:Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants. Measure:Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 Timepoints:Baseline up to Week 52 ; Outcome name:Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms. Measure:Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 Timepoints:Baseline up to Week 52 ; Outcome na | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Colombia, Mexico, Peru, Russian Federation, South Africa, United States
Outcome results
None listed