Back to resultsSix-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation (rehabilitate)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Inhalation gas
Inhalation Nitrogen/Oxygen
Inhalation Helium/Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Six-Minute Walk Test
Eligibility Criteria
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
Sites / Locations
- Asklepios Fachkliniken München-Gauting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Inhalation Nitrogen/Oxygen
Inhalation Helium/Oxygen
Inhalation gas
Arm Description
Nitrogen/Oxygen (65%/35%)
Helium/Oxygen (65%/35%)
Medicinal oxygen 100% via NIV with FiO2 of 0.35
Outcomes
Primary Outcome Measures
Distance walked
evaluate the distance walked by patients during a Six-Minute Walk Test
Secondary Outcome Measures
Assessment of the safety of inhalation Helium/Oxygen
evaluate the safety of the administration of Helium/Oxygen 65%/35%
Full Information
NCT ID
NCT01355809
First Posted
May 17, 2011
Last Updated
August 8, 2014
Sponsor
Air Liquide SA
Collaborators
Asklepios Kliniken Hamburg GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01355809
Brief Title
Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation
Acronym
rehabilitate
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to low recruitment rate the sponsor decided to discontinue the study.
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide SA
Collaborators
Asklepios Kliniken Hamburg GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Six-Minute Walk Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhalation Nitrogen/Oxygen
Arm Type
Active Comparator
Arm Description
Nitrogen/Oxygen (65%/35%)
Arm Title
Inhalation Helium/Oxygen
Arm Type
Experimental
Arm Description
Helium/Oxygen (65%/35%)
Arm Title
Inhalation gas
Arm Type
Experimental
Arm Description
Medicinal oxygen 100% via NIV with FiO2 of 0.35
Intervention Type
Drug
Intervention Name(s)
Inhalation gas
Other Intervention Name(s)
Experimental
Intervention Description
Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
Intervention Type
Drug
Intervention Name(s)
Inhalation Nitrogen/Oxygen
Other Intervention Name(s)
Active Comparator
Intervention Description
Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
Intervention Type
Drug
Intervention Name(s)
Inhalation Helium/Oxygen
Other Intervention Name(s)
Experimental He
Intervention Description
Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes
Primary Outcome Measure Information:
Title
Distance walked
Description
evaluate the distance walked by patients during a Six-Minute Walk Test
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Assessment of the safety of inhalation Helium/Oxygen
Description
evaluate the safety of the administration of Helium/Oxygen 65%/35%
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl HAUSSINGER, Prof Dr Med
Organizational Affiliation
Asklepios fachkliniken München-Gauting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Fachkliniken München-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
12. IPD Sharing Statement
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Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation
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