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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Inhalation Nitrogen/Oxygen; Drug: Inhalation Helium/Oxygen; Drug: Inhalation gas

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken München-Gauting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Liquide SA
• Collaborators: Asklepios Kliniken Hamburg GmbH
• Investigators: Principal Investigator: Karl HAUSSINGER, Prof Dr Med, Asklepios Fachkliniken München-Gauting

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: August 8, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Six-Minute Walk Test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ALMED-07-C2-017