Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Key facts

Study ID

NCT01914757

Run by

AstraZeneca

People needed

2508

Starts

2013-08-01

Expected to finish

2016-03-01

Last updated by the study team

2017-01-25

Who can join

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

You may qualify if…

• Provision of informed consent prior to any study specific procedures
• Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
• 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. 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. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

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 — Birmingham, Alabama, United States
• Research Site — Flagstaff, Arizona, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Alhambra, California, United States
• Research Site — Anaheim, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — Lakewood, California, United States
• Research Site — North Hollywood, California, United States
• Research Site — Northridge, California, United States
• Research Site — Palmdale, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — Rolling Hills Estate, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Stockton, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Upland, California, United States
• Research Site — Ventura, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Westminster, California, United States
• Research Site — Woodland, California, United States
• Research Site — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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