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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

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.

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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

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhalation Nitrogen/Oxygen

Nitrogen/Oxygen (65%/35%)

Group Type ACTIVE_COMPARATOR

Inhalation Nitrogen/Oxygen

Intervention Type DRUG

Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes

Inhalation Helium/Oxygen

Helium/Oxygen (65%/35%)

Group Type EXPERIMENTAL

Inhalation Helium/Oxygen

Intervention Type DRUG

Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes

Inhalation gas

Medicinal oxygen 100% via NIV with FiO2 of 0.35

Group Type EXPERIMENTAL

Inhalation gas

Intervention Type DRUG

Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes

Interventions

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Inhalation gas

Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes

Intervention Type DRUG

Inhalation Nitrogen/Oxygen

Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes

Intervention Type DRUG

Inhalation Helium/Oxygen

Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes

Intervention Type DRUG

Other Intervention Names

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Experimental Active Comparator Experimental He

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No