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

NCT03441204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2024-04-08

No results posted yet for this study

Summary

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).

Conditions

  • Chronic Respiratory Failure With Hypoxia

Interventions

DRUG

LTOT 24 h/day

LTOT prescribed for 24 h/day.

DRUG

LTOT 15h/day

: LTOT prescribed for 15 h/day. The patient is instructed to use LTOT during sleep and not to use LTOT for about 9 hours during daytime, totalling 15 h/day.

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Blekinge County Council Hospital

    collaborator OTHER

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Magnus Ekström, MD, PhD · Blekinge County Council Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2022-04-04
Completion
2023-04-04

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441204 on ClinicalTrials.gov