EUCTR2010-020127-52-DE
Active, not recruiting
Not Applicable
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
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease and Sputum Eosinophilia
- Sponsor
- AstraZeneca AB
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 12 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
Exclusion Criteria
- •1\. Any condition that, in the opinion of the investigator, 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 the Investigator, or any other
- •relevant cardiovascular disorder as judged by the Investigator.
- •3\. Pregnant, breastfeeding and lactating women.
- •4\. Known history of allergy or reaction to any component of the
- •investigational product formulation, budesonide/formoterol
Outcomes
Primary Outcomes
Not specified
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