Clinical Research Details

Study of Benralizumab in Patients with Chronic Obstructive Pulmonary Disease with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils

Study Description

This study is being carried out to evaluate benralizumab (study drug) compared to placebo (an inactive substance) as a medicine to treat moderate to very severe COPD associated with elevated blood eosinophils and history of frequent exacerbation.

Inclusion/Exclusion Criteria

Inclusion Criteria:

1. Current smoker or ex-smoker with a tobacco history of ≥10 pack-years

2. History of moderate to very severe COPD with a post-bronchodilator FEV1/forced vital
capacity (FVC)<0.70 and a post-bronchodilator FEV1 ≤65% of predicted normal value at
screening central spirometry assessment

3. Documented history of 2 or more moderate and/or severe COPD exacerbations12 that
required treatment with systemic corticosteroids (at least 3 days or a single depot
formulation injection) and/or hospitalization within 52 weeks prior to enrollment

4. Documented use of triple (ICS/LABA/LAMA1) background therapy for COPD for ≥3
months immediately prior to enrollment.

5. Blood eosinophil count ≥300/μL at screening

Exclusion criteria:

1. Clinically important pulmonary disease other than COPD (e.g. active lung infection,
clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation
syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and
primary ciliary dyskinesia).

2. Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA) or
other accepted guidelines, prior history of asthma, or asthma-COPD overlap

3. Radiological findings suggestive of a respiratory disease other than COPD that is
contributing to the patient’s respiratory symptoms.

4. Patients receiving long-term treatment with oxygen >4.0 liters/minute (L/min).

Open Enrollment

Contact Name: Kathleen Kiley
Contact Phone: (902) 244-9632
Contact Email: kathleen.kiley@jax.ufl.edu

Investigators