Oxygen DeficiencyNCT03396172
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
A study testing FreeDom in people with Oxygen Deficiency and COPD Exacerbation, run by Laval University at 1 site in Canada.
Trial summary
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Deficiency, COPD Exacerbation
- What is being tested?
- FreeDom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2018to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.
- known or suspected COPD to entry
- Age > or = 40 years
- Ex-smoker history (10 pack / year or more)
- Acute Exacerbation: dyspnea of recent onset (less than 15 days)
- The need for oxygen therapy with a moderate rate: <6L / min to maintain SpO2 > 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)
Who cannot join
- Refusal to consent to participate in the study,
- Indication for an imminent intubation according to the pulmonologist,
- Sleep Apnea
- NIV used at home
- Lack of FreeO2 system available at the time of randomization
- Non-autonomous and alone at home
Show all 9Show fewer
- Patient alone at home
- Patients who live more than 50 km from the hospital
- Patient already included in the study within 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
Read the detailed description
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.
The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.
- Conditions
- Oxygen Deficiency, COPD Exacerbation
- Being tested
- Control, FreeDom
- Keywords
- COPD, Homecare, Oxygen, Telemedicine, Automated oxygen adjustment, Rehabilitation program
- Medical subject headings
- Hypoxia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Usual oxygen administration and usual hospitalization
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
FreeDomDevice
Also called Early Hospital discharge with home hospitalisation
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria Receives: Other: Control |
| FreeDom | Active comparator | FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation):
-initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met.
After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization, Receives: Device: FreeDom |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of hospital days during COPD exacerbation at day 30.
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
Measured: 30 days
Secondary outcomes (5)
Rate of Emergency consultation and hospital readmission
Rate of Emergency consultation and hospital readmission
Measured: 1 and 3 months
Health Related Quality of Life
Survey of health related quality of life
Measured: 1 and 3 months
Cost of care at 3 months
Economic evaluation about these 2 different strategy of COPD exacerbation management using micro-costing approach and including the cost of the FreeO2 technology
Measured: 3 months
Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
The continuous measurement of SpO2 and O2 flow rate with the FreeO2 device (only in the FreeDom strategy) will allow the calculation of the % of time within the SpO2 target (recorded in the FreeO2) ± 2%, with hypoxemia (% of time with SpO2 < 85%) and with hyperoxia (% of time above SpO2 target +5%)
Measured: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
Number of consultations
Number of consultation : phone call, video consultation, rehabilitation, home visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start24 May 2018
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
- Investigators
- François Lellouche, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396172
- Sponsor's protocol ID
- 21419
- Status last verified
- Nov 2026
- First submitted
- 18 Dec 2017
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation
- ClinicalTrials.gov ID
- NCT03396172
- Acronym / sponsor ID
- 21419
- Conditions
- Oxygen Deficiency, COPD Exacerbation
- Keywords
- COPD, Homecare, Oxygen, Telemedicine, Automated oxygen adjustment, Rehabilitation program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Jan 2018 (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.
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
Detailed description
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.
The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlThe intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria |
| FreeDom | Active comparator | Device: FreeDomFreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation): -initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met. After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.
- known or suspected COPD to entry
- Age > or = 40 years
- Ex-smoker history (10 pack / year or more)
- Acute Exacerbation: dyspnea of recent onset (less than 15 days)
Key exclusion criteria (9 listed)
- Refusal to consent to participate in the study,
- Indication for an imminent intubation according to the pulmonologist,
- Sleep Apnea
- NIV used at home
- Lack of FreeO2 system available at the time of randomization
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 |
|---|---|---|
| ControlAlso: Usual oxygen administration and usual hospitalizationThe hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria | Other | Control |
| FreeDomAlso: Early Hospital discharge with home hospitalisationEarly return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation | Device | FreeDom |
Primary outcome
The number of hospital days during COPD exacerbation at day 30.
Time frame: 30 days
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
5 secondary outcomes
Rate of Emergency consultation and hospital readmission
Time frame: 1 and 3 months
Health Related Quality of Life
Time frame: 1 and 3 months
Cost of care at 3 months
Time frame: 3 months
Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
Time frame: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
Number of consultations
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
François Lellouche principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeDom in people with Oxygen Deficiency and COPD Exacerbation, run by Laval University at 1 site in Canada.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
The number of hospital days during COPD exacerbation at day 30. (time frame: 30 days). 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 4 Nov 2026.