NCT01448850

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

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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 Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
BIOLOGICAL	MEDI8968 600 mg IV, 300 mg SC	MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
OTHER	Placebo	Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-10-07
• Last updated: 2017-01-30
• Results posted: 2017-01-30

Locations

60 sites across 10 countries: United States, Bulgaria, Czechia, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, United Kingdom