UnknownNot Applicable

FreeDom: Innovative Strategy for the Management of COPD Exacerbations

Canada100 participantsStarted 2018-05-24

Plain-language 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. The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) Exclusion Criteria: * 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 * Patient alone at home * Patients who live more than 50 km from the hospital * Patient already included in the study within 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of hospital days during COPD exacerbation at day 30.

Timeframe: 30 days

Trial details

NCT IDNCT03396172

SponsorLaval University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

François Lellouche

418-656-8711 francois.lellouche@criucpq.ulaval.ca

View on ClinicalTrials.gov More Oxygen Deficiency trials