Chronic Respiratory DiseaseObsO2NCT03188588
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients
An observational study of Chronic Respiratory Disease and Hypoxemia, run by SOS Oxygene Mediterranee at 1 site in France.
Trial summary
Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Respiratory Disease, Hypoxemia
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 1 Jan 2020
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients are recruited from pneumologia unit of hospital and from private pneumologists
Who may be able to join
- chronic respiratory disease patients with chronic hypoxemia
- First prescribed long term oxygenotherapy
Who cannot join
- patients with NIV and CPAP
- vital pronostic < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.
- Conditions
- Chronic Respiratory Disease, Hypoxemia
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen use
time of oxygen use
Measured: 6 month
Secondary outcomes (3)
respiratory disease severity based on GOLD standards
Measured: baseline
quality of life assessed by a questionnaire (VQ-11)
Measured: baseline, 3 month and 6 month
precarity score assessed by a questionnaire (EPICE)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startJan 2017
- Primary completionJan 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOS Oxygene Mediterranee
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CHU Arnaud de Villeneuve MONTPELLIER
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, Professor, Principal investigator, CHU Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188588
- Sponsor's protocol ID
- 2016-A01244-47
- Acronym
- ObsO2
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients
- ClinicalTrials.gov ID
- NCT03188588
- Acronym / sponsor ID
- ObsO2 / 2016-A01244-47
- Conditions
- Chronic Respiratory Disease, Hypoxemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SOS Oxygene MediterraneeIndustry (pharma, biotech, devices)
- Collaborators
- CHU Arnaud de Villeneuve MONTPELLIER
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- 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.
Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients are recruited from pneumologia unit of hospital and from private pneumologists
Key inclusion criteria (2 listed)
- chronic respiratory disease patients with chronic hypoxemia
- First prescribed long term oxygenotherapy
Key exclusion criteria (2 listed)
- patients with NIV and CPAP
- vital pronostic < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oxygen use
Time frame: 6 month
time of oxygen use
3 secondary outcomes
respiratory disease severity based on GOLD standards
Time frame: baseline
quality of life assessed by a questionnaire (VQ-11)
Time frame: baseline, 3 month and 6 month
precarity score assessed by a questionnaire (EPICE)
Time frame: baseline
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 23 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Arnaud Bourdin, Professor principal investigator
CHU Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease and Hypoxemia, run by SOS Oxygene Mediterranee 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 2 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 23 Sep 2020. 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 use (time frame: 6 month). 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 23 Sep 2020.