A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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 symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.

Key facts

Study ID

NCT01448850

Run by

MedImmune LLC

People needed

464

Starts

2011-11-01

Expected to finish

2014-02-01

Last updated by the study team

2017-01-30

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Newcastle upon Tyne, United Kingdom
• Research Site — Wolverhampton, United Kingdom
• Research Site — Peoria, Arizona, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Duluth, Georgia, United States
• Research Site — Auburn, Maine, United States
• Research Site — Buffalo, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Boerne, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Plovdiv, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Stara Zagora, Bulgaria
• Research Site — Veliko Tarnovo, Bulgaria
• Research Site — Brno, Czechia
• Research Site — Jindřichův Hradec, Czechia
• Research Site — Karlovy Vary, Czechia
• Research Site — Pilsen, Czechia
• Research Site — Prague, Czechia
• Research Site — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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