A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, CHRONIC DOSING (56 WEEK)PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE, PHASE III STUDY TOEVALUATE THE EFFICACY AND SAFETY OF 3 DOSES OF BENRALIZUMAB (MEDI-563) INPATIENTS WITH MODERATE TO VERY SEVERE CHRONIC OBSTRUCTIVE PULMONARYDISEASE (COPD) WITH A HISTORY OF COPD EXACERBATIONS (TERRANOVA)

Not Applicable

Recruiting

• Conditions: -J44 Other chronic obstructive pulmonary disease; Other chronic obstructive pulmonary disease; J44

• Registration Number: PER-040-14
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-13
• Study Completion: 2018-07-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures.
2.Female or male subjects aged 40-85 years inclusive
3.History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1>20% and ≤65% of predicted normal value at screening (central spirometry will be used for this criteria assessment).
4.History of 2 or more moderate COPD exacerbations that required treatment with systemic corticosteroids and/or antibiotics,
5.mMRC score ≥1 at Visit 1
6.Subjects should have evidence of having been treated with double (ICS/LABA or LABA/LAMA) or triple (ICS/LABA/LAMA) therapy approved for COPD in a given country in the year prior to enrolment (Visit 1).
Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the Investigator).
7.Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception Ability to read, write and use electronic devices.
Additional criteria to be checked prior to randomisation:
8.Blood eosinophils.
9.Compliance with the eDiary
At least 70% compliance with the subject’s maintenance therapy

Exclusion Criteria

1.Clinically important pulmonary disease other than COPD
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
3.Unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, renal failure, uncontrolled hypertension as defined by the Investigator
4.Treatment with systemic corticosteroids and/or antibiotics,
5.Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to enrolment (Visit 1).
6.Pneumonia within 8 weeks prior to enrolment (Visit 1), based on the last day of antibiotic treatment or hospitalization date, whatever occurred later.
7.Pregnant, breastfeeding, or lactating women.
8.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥1.5 times the upper limit of normal (ULN) confirmed by repeated testing during screening period
9.Risk factors for pneumonia (immunosuppression, neurological disorder with increased risk of aspiration).
10.Known history of allergy or reaction to any component of the investigational product formulation.
11.History of anaphylaxis to any other biologic therapy.
12.Donation of blood, plasma or platelets within the past 90 days prior to Visit 1.
13.Long term oxygen therapy (LTOT) with signs and/or symptoms of cor pulmonale and/or right ventricular failure..
14.Use of any non-invasive positive pressure ventilation device (NIPPV)..

Study & Design

• Study Type: Interventional
• Study Design: Not specified