Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

Key facts

Study ID

NCT01928771

Run by

AstraZeneca

People needed

2681

Starts

2013-09-19

Expected to finish

2016-04-05

Last updated by the study team

2017-05-03

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
• Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
• History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
• Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
• For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
• For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

You may not qualify if…

• 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)
• 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
• 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
• 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

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Scottsboro, Alabama, United States
• Research Site — Sheffield, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Bakersfield, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Costa Mesa, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Huntington Park, California, United States
• Research Site — Los Angles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Orange, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Jose, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Brandon, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Cutler Bay, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Foley, Alabama, United States

Full record on ClinicalTrials.gov

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