Pulmonary Disease, Chronic ObstructivePhase 2rehabilitateNCT01355809
Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation
A Phase 2 study testing Inhalation gas, Inhalation Nitrogen/Oxygen and Inhalation Helium/Oxygen in people with Pulmonary Disease, Chronic Obstructive, run by Air Liquide SA at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Inhalation gas, Inhalation Nitrogen/Oxygen and Inhalation Helium/Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Inhalation gas, Inhalation Nitrogen/Oxygen, Inhalation Helium/Oxygen
- Keywords
- Six-Minute Walk Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation gasDrug
Also called Experimental
Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
Inhalation Nitrogen/OxygenDrug
Also called Active Comparator
Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
Inhalation Helium/OxygenDrug
Also called Experimental He
Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes
| Study group | Role | What they receive |
|---|---|---|
| Inhalation Nitrogen/Oxygen | Active comparator | Nitrogen/Oxygen (65%/35%) Receives: Drug: Inhalation Nitrogen/Oxygen |
| Inhalation Helium/Oxygen | Experimental | Helium/Oxygen (65%/35%) Receives: Drug: Inhalation Helium/Oxygen |
| Inhalation gas | Experimental | Medicinal oxygen 100% via NIV with FiO2 of 0.35 Receives: Drug: Inhalation gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked
evaluate the distance walked by patients during a Six-Minute Walk Test
Measured: 6 minutes
Secondary outcomes (1)
Assessment of the safety of inhalation Helium/Oxygen
evaluate the safety of the administration of Helium/Oxygen 65%/35%
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionMay 2011
Why it stopped: Due to low recruitment rate the sponsor decided to discontinue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asklepios Kliniken Hamburg GmbH
- Responsible party
- Sponsor
- Investigators
- Karl HAUSSINGER, Prof Dr Med, Principal investigator, Asklepios fachkliniken München-Gauting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355809
- Sponsor's protocol ID
- ALMED-07-C2-017
- Acronym
- rehabilitate
- Status last verified
- Aug 2014
- First submitted
- 17 May 2011
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01355809
- Acronym / sponsor ID
- rehabilitate / ALMED-07-C2-017
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Six-Minute Walk Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment rate the sponsor decided to discontinue the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Air Liquide SAIndustry (pharma, biotech, devices)
- Collaborators
- Asklepios Kliniken Hamburg GmbH
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhalation Nitrogen/Oxygen | Active comparator | Drug: Inhalation Nitrogen/OxygenNitrogen/Oxygen (65%/35%) |
| Inhalation Helium/Oxygen | Experimental | Drug: Inhalation Helium/OxygenHelium/Oxygen (65%/35%) |
| Inhalation gas | Experimental | Drug: Inhalation gasMedicinal oxygen 100% via NIV with FiO2 of 0.35 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation gasAlso: ExperimentalInhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes | Drug | Inhalation gas |
| Inhalation Nitrogen/OxygenAlso: Active ComparatorInhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes | Drug | Inhalation Nitrogen/Oxygen |
| Inhalation Helium/OxygenAlso: Experimental HeInhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes | Drug | Inhalation Helium/Oxygen |
Primary outcome
Distance walked
Time frame: 6 minutes
evaluate the distance walked by patients during a Six-Minute Walk Test
1 secondary outcome
Assessment of the safety of inhalation Helium/Oxygen
Time frame: 6 minutes
Results and safety
The study was stopped early (reason given: Due to low recruitment rate the sponsor decided to discontinue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl HAUSSINGER, Prof Dr Med principal investigator
Asklepios fachkliniken München-Gauting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhalation gas, Inhalation Nitrogen/Oxygen and Inhalation Helium/Oxygen in people with Pulmonary Disease, Chronic Obstructive, run by Air Liquide SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to low recruitment rate the sponsor decided to discontinue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.