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

Study Overview
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Brief Summary
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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
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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

Official Title
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Single Centre, Exploratory, Phase II, Cross-over, Randomised Trial, Evaluating the Effect of Spontaneously Breathing He/O2 65%/35% to Either Spontaneously Breathing N2/O2 65%35% or Non-Invasive Ventilated N2/O2 65%/35% on a 6 Minute Walk Test in Severe COPD Patients

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Inhalation gas
* Drug: Inhalation Nitrogen/Oxygen
* Drug: Inhalation Helium/Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inhalation Nitrogen/Oxygen<br>Nitrogen/Oxygen (65%/35%) | Drug: Inhalation Nitrogen/Oxygen<br>* Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes<br>* Other names: Active Comparator;|
| Experimental: Inhalation Helium/Oxygen<br>Helium/Oxygen (65%/35%) | Drug: Inhalation Helium/Oxygen<br>* Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes<br>* Other names: Experimental He;|
| Experimental: Inhalation gas<br>Medicinal oxygen 100% via NIV with FiO2 of 0.35 | Drug: Inhalation gas<br>* Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes<br>* Other names: Experimental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked | evaluate the distance walked by patients during a Six-Minute Walk Test | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety of inhalation Helium/Oxygen | evaluate the safety of the administration of Helium/Oxygen 65%/35% | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Six-Minute Walk Test