NCT06247397 Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
| NCT ID | NCT06247397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skane University Hospital |
| Condition | Chronic Obstructive Pulmonary Disease Severe |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 310 participants in total. It began in 2024-06-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
Eligibility Criteria
Inclusion Criteria: * Age 40 years or older * Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox * COPD or ILD as main underlying reason for LTOT * Oxygen concentrator as stationary oxygen source in the home including night-time * Body mass index (BMI) \< 35 kg/m2 Exclusion Criteria: * Current or previous treatment with home HFOT * Current treatment with home mechanical ventilation * Current treatment with home CPAP * Hospitalized during the last 2 weeks * Current smoking or contact with flames * Self-reported average use of the LTOT \< 15h per day (24 hours) * PaCO2 (breathing air at rest) \> 8 kPa * Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff) * Inability to participate in the study procedures (as judged by the staff) * Not eligible for continuing LTOT due to other reason (as judged by the staff) * Expected survival less than 3 months (as judged by the staff)
Contact & Investigator
Magnus Ekström, MD, PhD
PRINCIPAL INVESTIGATOR
Skane University Hospital
Frequently Asked Questions
Who can join the NCT06247397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease Severe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06247397 currently recruiting?
Yes, NCT06247397 is actively recruiting participants. Contact the research team at magnus.ekstrom@med.lu.se for enrollment information.
Where is the NCT06247397 trial being conducted?
This trial is being conducted at Karlskrona, Sweden, Örebro, Sweden.
Who is sponsoring the NCT06247397 clinical trial?
NCT06247397 is sponsored by Skane University Hospital. The principal investigator is Magnus Ekström, MD, PhD at Skane University Hospital. The trial plans to enroll 310 participants.