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FreeDom Strategy for COPD Exacerbations

N/A
Recruiting
Led By François Lellouche
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Age > or = 40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 3 months
Awards & highlights

Study Summary

This trial tests an innovative strategy to reduce hospital stay for people with COPD by 50%, using early discharge, automated O2, telemedicine and tele-rehabilitation.

Who is the study for?
This trial is for COPD patients needing moderate oxygen therapy (<6L/min) to maintain SpO2 > 90%, hospitalized for less than 48 hours, aged over 40 with a history of smoking. It's not for those non-autonomous and alone at home, refusing consent, needing imminent intubation, with sleep apnea or living far from the hospital (>50 km).Check my eligibility
What is being tested?
The 'FreeDom' strategy is being tested to cut hospital stays by half in COPD exacerbation cases. It includes early discharge, automated O2 weaning using FreeO2 system, telemedicine and tele-rehabilitation.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include issues related to changes in oxygen levels due to automated weaning and complications from reduced medical supervision post-discharge.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need less than 6L/min of oxygen to keep my oxygen levels above 90%.
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I am 40 years old or older.
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I was hospitalized for a severe COPD flare-up but stayed less than 48 hours.
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I have been diagnosed with or suspected to have COPD.
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I have smoked 10 or more packs a year in the past.
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I have had trouble breathing for less than 15 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of hospital days during COPD exacerbation at day 30.
Secondary outcome measures
Cost of care at 3 months
Health Related Quality of Life
Number of consultations
+2 more

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510
30%
Pain with injection of propofol
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ControlExperimental Treatment1 Intervention
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
Group II: FreeDomActive Control1 Intervention
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,

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
416 Previous Clinical Trials
172,176 Total Patients Enrolled
François LellouchePrincipal InvestigatorLaval University

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT03396172 — N/A
Oxygen Deficiency Research Study Groups: FreeDom, Control
Oxygen Deficiency Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT03396172 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396172 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could a person join this clinical examination at present?

"According to official data on clinicaltrials.gov, this clinical experiment is actively recruiting participants. It was initially listed in May 2018 and updated most recently in April 2023."

Answered by AI

To what extent is participation in this medical experiment being conducted?

"Affirmative, the information on clinicaltrials.gov confirms that this research study is currently enrolling participants. Initially posted on May 24th 2018 and last modified April 3rd 2023, 100 individuals are required to take part from a single site."

Answered by AI
~17 spots leftby Jun 2025