Study Stopped
Due to low recruitment rate the sponsor decided to discontinue the study.
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
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedAugust 11, 2014
August 1, 2014
1.2 years
May 17, 2011
August 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance walked
evaluate the distance walked by patients during a Six-Minute Walk Test
6 minutes
Secondary Outcomes (1)
Assessment of the safety of inhalation Helium/Oxygen
6 minutes
Study Arms (3)
Inhalation Nitrogen/Oxygen
ACTIVE COMPARATORNitrogen/Oxygen (65%/35%)
Inhalation Helium/Oxygen
EXPERIMENTALHelium/Oxygen (65%/35%)
Inhalation gas
EXPERIMENTALMedicinal oxygen 100% via NIV with FiO2 of 0.35
Interventions
Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Air Liquide SAlead
- Asklepios Kliniken Hamburg GmbHcollaborator
Study Sites (1)
Asklepios Fachkliniken München-Gauting
Gauting, Gauting, 82131, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl HAUSSINGER, Prof Dr Med
Asklepios fachkliniken München-Gauting
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 18, 2011
Study Start
December 1, 2009
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
August 11, 2014
Record last verified: 2014-08