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

Overview

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.

Full Title of Study: “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% or Non-Invasive Ventilated N2/O2 65%/35% on a 6 Minute Walk Test in Severe COPD Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

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

Interventions

  • Drug: Inhalation gas
    • Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
  • Drug: Inhalation Nitrogen/Oxygen
    • Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
  • Drug: Inhalation Helium/Oxygen
    • Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes

Arms, Groups and Cohorts

  • Active Comparator: Inhalation Nitrogen/Oxygen
    • Nitrogen/Oxygen (65%/35%)
  • Experimental: Inhalation Helium/Oxygen
    • Helium/Oxygen (65%/35%)
  • Experimental: Inhalation gas
    • Medicinal oxygen 100% via NIV with FiO2 of 0.35

Clinical Trial Outcome Measures

Primary Measures

  • Distance walked
    • Time Frame: 6 minutes
    • evaluate the distance walked by patients during a Six-Minute Walk Test

Secondary Measures

  • Assessment of the safety of inhalation Helium/Oxygen
    • Time Frame: 6 minutes
    • evaluate the safety of the administration of Helium/Oxygen 65%/35%

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Liquide SA
  • Collaborator
    • Asklepios Kliniken Hamburg GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karl HAUSSINGER, Prof Dr Med, Principal Investigator, Asklepios fachkliniken München-Gauting

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