Chronic Obstructive Pulmonary DiseaseNCT00875719
Oxygen Portable Concentrator During Exercises in Patients With COPD
A study testing Oxygen concentrators versus constant flow axygen and oxygen concentrator in people with Chronic Obstructive Pulmonary Disease, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Oxygen concentrators versus constant flow axygen and oxygen concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Feb 2011
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.
Who cannot join
- Evolutive heart disease.
- Unability to understand or realize the tests.
- Acute exacerbation during the last month.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey
Limoges, 87042
About this study
Official title: Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure
The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.
Read the detailed description
Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Oxygen concentrators versus constant flow axygen, oxygen concentrator
- Keywords
- COPD patients with respiratory failure
- 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.
Oxygen concentrators versus constant flow axygenDevice
Also called portable oxygen concentrator
Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.
oxygen concentratorDevice
Also called portable concentrator
comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
| Study group | Role | What they receive |
|---|---|---|
| continuous v intermittent Oxygen therapy | Active comparator | intermittent oxygen compared to constant flow oxygen as regards walking distance Receives: Device: Oxygen concentrators versus constant flow axygen; Device: oxygen concentrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
Measured: One day
Secondary outcomes (1)
Walking Distance
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Investigators
- Boris MELLONI, Pr, Principal investigator, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875719
- Sponsor's protocol ID
- ANTADIR CMTS OXYGEN 2009
- Status last verified
- Feb 2011
- First submitted
- 27 Mar 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT00875719
- Acronym / sponsor ID
- ANTADIR CMTS OXYGEN 2009
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD patients with respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Apr 2009 (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 compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.
Detailed description
Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| continuous v intermittent Oxygen therapy | Active comparator | Device: Oxygen concentrators versus constant flow axygen, Device: oxygen concentratorintermittent oxygen compared to constant flow oxygen as regards walking distance |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.
Key exclusion criteria (3 listed)
- Evolutive heart disease.
- Unability to understand or realize the tests.
- Acute exacerbation during the last month.
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 |
|---|---|---|
| Oxygen concentrators versus constant flow axygenAlso: portable oxygen concentratorEach patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order. | Device | continuous v intermittent Oxygen therapy |
| oxygen concentratorAlso: portable concentratorcomparison walk distance and saturation with continuous oxygen compared to intermittent oxygen | Device | continuous v intermittent Oxygen therapy |
Primary outcome
Oxygen Saturation
Time frame: One day
1 secondary outcome
Walking Distance
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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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.
Boris MELLONI, Pr principal investigator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen concentrators versus constant flow axygen and oxygen concentrator in people with Chronic Obstructive Pulmonary Disease, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Feb 2011. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygen Saturation (time frame: One day). 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 16 Feb 2011; AzTrials last refreshed its copy on 2 Nov 2026.