LUNG DISEASES, OBSTRUCTIVENCT01180803
Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
A study testing pulse oxygen supplementation devices and continuous oxygen in people with LUNG DISEASES, OBSTRUCTIVE, 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 the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- LUNG DISEASES, OBSTRUCTIVE
- What is being tested?
- pulse oxygen supplementation devices and continuous oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Dec 2023
- 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 on necessity of long term oxygen therapy
- Able to give their written consent
Who cannot join
- Unstable patients with COPD
- Patients with restrictive respiratory disease
- Patients with cardiac or neurologic disease contre-indicating the different evaluations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Fédération ANTADIR
Paris, 75006
Jacqueline DELRIEU, Ph. D, +33.1.56.81.40.60, delrieu@antadir.com
Boris MELLONI, Pr
About this study
The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.
- Conditions
- LUNG DISEASES, OBSTRUCTIVE
- Being tested
- pulse oxygen supplementation devices, continuous oxygen
- Keywords
- COPD - long term oxygenotherapy, COPD patients with respiratory failure
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse oxygen supplementation devicesDevice
Also called pulse group
oxygen therapy delivered by systems using oxygen-saving valves
continuous oxygenDevice
Also called continuous group
oxygen therapy delivered by continuous liquid oxygen devices
| Study group | Role | What they receive |
|---|---|---|
| oxygen-saving valves | Experimental | Not described Receives: Device: pulse oxygen supplementation devices |
| continuous oxygen supplementation | Active comparator | Not described Receives: Device: continuous oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation during 6 minutes walking test
Measured: 1 day
Secondary outcomes (1)
Walking distance during the 6 minutes walking test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUNG DISEASES, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180803
- Sponsor's protocol ID
- EVAL- CLIN A00690-39
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2010
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
- ClinicalTrials.gov ID
- NCT01180803
- Acronym / sponsor ID
- EVAL- CLIN A00690-39
- Conditions
- LUNG DISEASES, OBSTRUCTIVE
- Keywords
- COPD - long term oxygenotherapy, COPD patients with respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Aug 2010 (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 the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen-saving valves | Experimental | Device: pulse oxygen supplementation devices |
| continuous oxygen supplementation | Active comparator | Device: continuous oxygen |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD on necessity of long term oxygen therapy
- Able to give their written consent
Key exclusion criteria (3 listed)
- Unstable patients with COPD
- Patients with restrictive respiratory disease
- Patients with cardiac or neurologic disease contre-indicating the different evaluations
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 |
|---|---|---|
| pulse oxygen supplementation devicesAlso: pulse groupoxygen therapy delivered by systems using oxygen-saving valves | Device | oxygen-saving valves |
| continuous oxygenAlso: continuous groupoxygen therapy delivered by continuous liquid oxygen devices | Device | continuous oxygen supplementation |
Primary outcome
oxygen saturation during 6 minutes walking test
Time frame: 1 day
1 secondary outcome
Walking distance during the 6 minutes walking test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulse oxygen supplementation devices and continuous oxygen in people with LUNG DISEASES, OBSTRUCTIVE, 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 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris MELLONI, Pr (+33 1. 56. 81. 40. 60, melloni@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation during 6 minutes walking test (time frame: 1 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 29 Mar 2023.