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TerminatedNCT01355809rehabilitateUpdated Aug 11, 2014

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

A Phase 2 interventional study of Inhalation gas and Inhalation Nitrogen/Oxygen in Pulmonary Disease, Chronic Obstructive, sponsored by Air Liquide SA. Terminated at 1 site in Germany. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-11.

Sponsored by Air Liquide SA · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to low recruitment rate the sponsor decided to discontinue the study.
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Six-Minute Walk Test
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 3 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Air Liquide SA is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Active comparator
    Inhalation Nitrogen/Oxygen

    Nitrogen/Oxygen (65%/35%)

    Drug: Inhalation Nitrogen/Oxygen

  • Experimental
    Inhalation Helium/Oxygen

    Helium/Oxygen (65%/35%)

    Drug: Inhalation Helium/Oxygen

  • Experimental
    Inhalation gas

    Medicinal oxygen 100% via NIV with FiO2 of 0.35

    Drug: Inhalation gas

Interventions

  • DrugInhalation gas

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

    Also known as: Experimental

  • DrugInhalation Nitrogen/Oxygen

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

    Also known as: Active Comparator

  • DrugInhalation Helium/Oxygen

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

    Also known as: Experimental He

06

What researchers measure

Primary outcomes

  1. Distance walked

    evaluate the distance walked by patients during a Six-Minute Walk Test

    Time frame: 6 minutes

Secondary outcomes

  1. Assessment of the safety of inhalation Helium/Oxygen

    evaluate the safety of the administration of Helium/Oxygen 65%/35%

    Time frame: 6 minutes

07

Study locations

1 site
  • Asklepios Fachkliniken München-Gauting
    Gauting, 82131, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01355809
Lead sponsor
Air Liquide SA
Collaborators
Asklepios Kliniken Hamburg GmbH
Responsible party
Sponsor
First posted
May 18, 2011
Start date
Dec 2009
Primary completion
Mar 2011
Completion
May 2011
Last update
Aug 11, 2014

Study contacts

Karl HAUSSINGER, Prof Dr Med
principal investigator · Asklepios fachkliniken München-Gauting

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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