Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Inhalation Helium/Oxygen; Drug: Inhalation gas; Drug: Inhalation Nitrogen/Oxygen

• Registration Number: NCT01355809
• Lead Sponsor: Air Liquide SA

Brief Summary

The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.

Detailed Description

the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Male or female aged >= 45 and <= 75 years old
• Patient with documented clinical diagnosis of stage III/IV COPD
• Patient with stable COPD defined by no significant increase in COPD medication, no treatment for COPD in an emergency, no acute intensive care setting and no intake of antibiotics in the four weeks prior to selection

Exclusion Criteria

• Inability or contra-indication to perform pulmonary function tests
• Inability or contra-indication to perform the 6MWT with a trolley
• Any contra-indication to receive NIV
• Obese patient having a Body Mass Index (BMI) > 35
• Pregnant or lactating woman
• Female or chil-bearing potential with lack of efficient contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhalation Helium/Oxygen	Inhalation Helium/Oxygen	Helium/Oxygen (65%/35%)
Inhalation gas	Inhalation gas	Medicinal oxygen 100% via NIV with FiO2 of 0.35
Inhalation Nitrogen/Oxygen	Inhalation Nitrogen/Oxygen	Nitrogen/Oxygen (65%/35%)

Primary Outcome Measures

Name	Time	Method
Distance walked	6 minutes	evaluate the distance walked by patients during a Six-Minute Walk Test

Secondary Outcome Measures

Name	Time	Method
Assessment of the safety of inhalation Helium/Oxygen	6 minutes	evaluate the safety of the administration of Helium/Oxygen 65%/35%

Trial Locations

Locations (1)

Asklepios Fachkliniken München-Gauting; 🇩🇪 Gauting, Germany