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

This study is currently recruiting participants.
Verified October 2011 by Air Liquide SA
Sponsor:
Collaborator:
Asklepios Kliniken Hamburg GmbH
Information provided by (Responsible Party):
Air Liquide SA
ClinicalTrials.gov Identifier:
NCT01355809
First received: May 17, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Inhalation gas
Drug: Inhalation Nitrogen/Oxygen
Drug: Inhalation Helium/Oxygen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre, Exploratory, Phase II, Cross-over, Randomised Trial, Evaluating the Effect of Spontaneously Breathing Helium/Oxygen 65%/35% to Either Spontaneously Breathing N2/O2 65%35% or Non-Invasive Ventilated Nitrogen/Oxygen 65%/35% on the Six-Minute Walking Distance in Severe COPD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Air Liquide SA:

Primary Outcome Measures:
  • Distance walked [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
    evaluate the distance walked by patients during a Six-Minute Walk Test


Secondary Outcome Measures:
  • Assessment of the safety of inhalation Helium/Oxygen [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]
    evaluate the safety of the administration of Helium/Oxygen 65%/35%


Estimated Enrollment: 24
Study Start Date: December 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Experimental

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355809

Locations
Germany
Asklepios Fachkliniken München-Gauting Recruiting
Gauting, Germany, 82131
Contact: Jens GEISELER, Dr     89 85 791 -4300 ext +49     j.geiseler@asklepios.com    
Contact: Claudia BUBULJ, Nurse     89 85 751 7302 ext +49     c.bubulj@asklepios.com    
Principal Investigator: Karl HAUSSINGER, Prof Dr med            
Sponsors and Collaborators
Air Liquide SA
Asklepios Kliniken Hamburg GmbH
Investigators
Principal Investigator: Karl HAUSSINGER, Prof Dr Med Asklepios fachkliniken München-Gauting
  More Information

No publications provided

Responsible Party: Air Liquide SA
ClinicalTrials.gov Identifier: NCT01355809     History of Changes
Other Study ID Numbers: ALMED-07-C2-017
Study First Received: May 17, 2011
Last Updated: October 21, 2011
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Keywords provided by Air Liquide SA:
Six-Minute Walk Test

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 21, 2013