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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ECHO/ICU  

Official title:

An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01155310
• Other study ID #: ALMED-07-C3-009
• Status: Terminated
• Phase: Phase 3
• First received: June 25, 2010
• Last updated: October 6, 2014
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsItaly: The Italian Medicines AgencyUnited Kingdom: National Health ServiceTunisia: Ministry of Public HealthSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Description:

Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.

During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.

Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 446
• Est. completion date: June 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Patient with known or suspected COPD

• Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure

• Patient eligible for Non-Invasive Ventilation (NIV)

• Patient admitted in an ICU

Exclusion Criteria:

• Patient who had lung transplant

• Patient having a contraindication to NIV

• Patient with tracheostomy

• Patient requiring Oxygen flow rate > 6 L/min or Inspired Oxygen Fraction (FIO2) > 0.50

• Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Helium/Oxygen 78%/22%
The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices. Patients will then receive the Air/Oxygen mixture with usual devices.
• Air/Oxygen
The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices. Patients will then receive the Air/Oxygen mixture with usual devices.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Les Cliniques Universitaires UCL Mont Godinne	Yvoir
France	Centre Hospitalier Universitaire Angers	Angers
France	Centre Hospitalier Universitaire Pellegrin-Tripode	Bordeaux
France	Hôpitaux de Chartes	Chartres
France	CHU Clermont-Ferrand - Hôpital ESTAING	Clermont-ferrand
France	Hôpital Henri Mondor	Creteil
France	CHU NICE - Hopital Pasteur	Nice
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse	Toulon
Italy	Azienda Ospedaliera Univeritaria Careggi	Firenze
Switzerland	Hôpitaux Universitaires de Genève	Genève
Tunisia	Hôpital Abderrahmen Mami	Ariana
Tunisia	Centre Hospitalier Universitaire Fattouma Bourguiba	Monastir
United Kingdom	University Hospital of North Tees	Stockton on Tees

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Switzerland,  Tunisia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of NIV failure	Endotracheal intubation and/or death	10 days (average)	No
Secondary	Duration of ICU stay and duration of index hospitalisation		10 days (average)	No
Secondary	Duration of invasive ventilation		10 days (average)	No
Secondary	Adverse events		6 months (post-randomization)	Yes
Secondary	Medico-economic parameters	Overall costs and cost-effectiveness	6 months	No
Secondary	Physiological and laboratory parameters	Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry	10 days (average)	Yes
Secondary	Duration of NIV sessions	Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally	10 days (average)	No
Secondary	Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD		6 months (post-randomization)	No