EUCTR2010-020127-52-GB
Active, not recruiting
Phase 1
A Phase 2a, double blind, placebo controlled study to evaluate the efficacy of MEDI-563 in subjects with moderate to severe COPD and sputum eosinophilia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AstraZeneca AB
- Enrollment
- 101
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects aged 40 to 85 years old at the time of screening.
- •2\. Written informed consent obtained from the subject prior to performing any
- •protocol\-related procedures.
- •3\. Documented history of moderate to severe COPD with a post\-bronchodilator
- •FEV1/FVC \< 0\.70 and a post\-bronchodilator FEV1 \< 80% predicted at screening.
- •4\. Documented history of 1 or more AECOPD that required treatment with systemic
- •corticosteroids and/or antibiotics, or hospitalization within 8 weeks \- 52 weeks
- •prior to Day 1\.
- •5\. Eosinophilia: greater or same as 3\.0% demonstrated on sputum within 12 months
- •prior to, or at screening.
Exclusion Criteria
- •1\. Any condition that would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •2\. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
- •failure, renal failure, uncontrolled hypertension as defined by Investigator or any other relevant cardiovascular disorder as judged by Investigator
- •3\. Pregnant, breastfeeding or lactating women
- •4\. Known history of allergy/reaction to any component of the investigational product formulation, budesonide/formoterol preparations, tiotropium bromide or terbutaline sulphate or any of their excipients
- •5\. History of anaphylaxis to any other biologic therapy
- •6\. Donation or transfusion of blood, plasma or platelets within past 90 Days prior to
- •7\. Other significant pulmonary disease as a primary diagnosis if a subject is diagnosed with any other pulmonary diseases as a secondary diagnosis they may be included if, in the opinion of the investigator/medical monitor, the inclusion does not compromise the interpretation of the study
- •8\. Receiving long\-term oxygen therapy (LTOT) at entry into the study. LTOT is defined as use of oxygen for a min. of 15 hrs per day
- •9\. Subjects who have past or present disease or disorder, which is judged by the investigator and the medical monitor, may either put the subject at risk because of participation in the study, or may affect outcome of the study. Subjects who have epilepsy must be on a stable dose of medication for 30 days prior to Day 1
Outcomes
Primary Outcomes
Not specified
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