CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 464 enrolled
Drug / intervention
MEDI8968 600 mg IV, 300 mg SC +1 morebiological
Likely dose
MEDI8968 600 mg IV, 300 mg SCfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01448850
NCT01448850Phase 2Completed

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

MedImmune LLC·interventional·Posted Oct 7, 2011·Updated Jan 30, 2017

In Brief

A Phase 2 clinical trial evaluating MEDI8968 600 mg IV, 300 mg SC and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 464 participants across 60 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Czechia, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.7 years ago

Interventions

MEDI8968 600 mg IV, 300 mg SCbiological

MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.

Placeboother

Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.