Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Due to low recruitment rate the sponsor decided to discontinue the study.)
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: August 8, 2014
Last verified: August 2014
  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: 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

Resource links provided by NLM:


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%


Enrollment: 3
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355809

Locations
Germany
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
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: August 8, 2014
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
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014