REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX)

NCT03441204 PHASE4 COMPLETED

Multicenter, phase IV, non-superiority, registry-based, randomized controlled trial. Patients starting long-term oxygen therapy (LTOT) are randomized between LTOT prescribed 24 h/day or 15 h/day using the Swedish Register for Respiratory Failure (Swedevox). Clinical follow-up and concurrent treatments are according to routine clinical practice. The main endpoints of mortality, hospitalizations, and incident disease are assessed using Swedish registry data, with expected complete follow-up. Patient-reported outcomes are assessed using a posted questionnaire at 3 and 12 months. The study is managed by the Uppsala Clinical Research Centre (UCR).

Details

Lead sponsor	Skane University Hospital
Phase	PHASE4
Status	COMPLETED
Enrolment	241
Start date	Wed May 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Apr 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Chronic Respiratory Failure With Hypoxia

Interventions

• LTOT 24 h/day
• LTOT 15h/day

Countries

Sweden