Status:
COMPLETED
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
MedImmune LLC
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomat...
Detailed Description
A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from W...
Eligibility Criteria
Inclusion
- Age 45 through 75 years
- Predicted (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II, III, and IV) at Screening
- History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
- Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
- Current smoker or ex-smoker with a tobacco history of more than or equal to (\>=) 10 pack-years.
Exclusion
- Past or present disease or disorder,
- Significant or unstable ischemic heart disease etc
- Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
- Past or current malignancy within the past 5 years
- Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
- Use of immunosuppressive medication receipt of any biologic agent.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT01448850
Start Date
November 1 2011
End Date
February 1 2014
Last Update
January 30 2017
Active Locations (60)
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1
Research Site
Peoria, Arizona, United States
2
Research Site
Clearwater, Florida, United States
3
Research Site
Duluth, Georgia, United States
4
Research Site
Auburn, Maine, United States