drugset / Trial / NCT01155310

Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

NCT01155310

Phase 3 Terminated 446 enrolled Air Liquide
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

Timeline

Start
2010-05
Primary completion
2013-10
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Helium/Oxygen Unknown Inhaled
Comparator Oxygen Other / unclassified Inhaled