A study to determine whether oxygen prescribed 24 h/day compared with 15 h/day in patients with chronic obstructive pulmonary disease (COPD) fails to improve mortality at 1 year

REgistry-based randomized controlled trial of treatment Duration and mortality in long-term OXygen therapy (REDOX) A Multicenter, Phase III, Registry-Based, Randomized Controlled Trial (R-RCT)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000441-32-SE

Enrollment

230

Registered

2016-03-15

Start date

2016-10-27

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic respiratory failure requiring LTOT (long-term oxygen treatment)

Interventions

Trade Name: Medicinal Oxygen Product Name: Medicinal Oxygen Pharmaceutical Form: Medicinal gas, compressed Trade Name: Medicinal Oxygen Product Name: Medicinal Oxygen Pharmaceutical Form: Medicinal g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 18 years or older • Standard eligibility criteria for non-palliative LTOT at rest: - PaO2 0.54) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115

Exclusion criteria

Exclusion criteria: • Standard contraindications for LTOT - Smoking or contact with open fire - Other inability to safely comply with LTOT • Already on LTOT for more than 2 weeks • Inability to comply with any of the study interventions (LTOT 15h /day or 24 h/ day) as judged by the responsible oxygen staff • Opt out from being registered in Swedevox • Inability to give informed written consent to participate in the study as judged by the oxygen responsible staff • Lack of Swedish identification number • Previous participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether oxygen prescribed 24 h/day compared with 15 h/day in patients starting LTOT for chronic respiratory failure fails to reduce the composite outcome of all-cause death or first hospitalization at 1 year.;Secondary Objective: To test whether LTOT 24 h/day fails to reduce all-cause mortality at 3 months; fails to decrease cause-specific mortality (respiratory and cardiovascular deaths); hospitalization rate; incident cardiovascular disease; breathlessness; fatigue; fails to improve self-reported physical activity; health-related quality of life; cognition; and patient preference to continue treatment at 3 and 12 months.;Primary end point(s): • Rate of all-cause death or first hospitalization at 1 year;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: To determine whether oxygen prescribed 24 h/day compared with 15 h/day in patients starting LTOT for chronic respiratory failure fails to reduce the composite outcome of all-cause death or first hospitalization at 1 year.;Secondary Objective: To test whether LTOT 24 h/day fails to reduce all-cause mortality at 3 months; fails to decrease cause-specific mortality (respiratory and cardiovascular deaths); hospitalization rate; incident cardiovascular disease; breathlessness; fatigue; fails to improve self-reported physical activity; health-related quality of life; cognition; and patient preference to continue treatment at 3 and 12 months.;Primary end point(s): • Rate of all-cause death or first hospitalization at 1 year;Timepoint(s) of evaluation of this end point: 1 year

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Secondary

Measure	Time frame
Secondary end point(s): • Mortality rate from all causes • Mortality rate from respiratory disease • Mortality rate from cardiovascular disease • Hospitalization rate from all causes • Hospitalization rate with a primary diagnosis of respiratory disease or respiratory infection • Hospitalization rate with a primary diagnosis of cardiovascular disease • Rate of an incident diagnosis of cardiovascular disease Self-reported data collected at 3 months: • Self-rated oxygen utilization • Breathlessness (Multidimensional Dyspnea Profile; MDP) • Fatigue (FACIT-Fatigue) • Informant-based cognitive questionnaire (IQCODE) • Cognition (IQCODE-SR and BAS) • Health-related quality of life (CAT and EQ5D-5L) • Global impression of change from baseline (GIC) • Self-reported physical activity • Preference of continuing treatment;Timepoint(s) of evaluation of this end point: At 3 and 12 months	—

Measure

Time frame

Secondary end point(s): • Mortality rate from all causes • Mortality rate from respiratory disease • Mortality rate from cardiovascular disease • Hospitalization rate from all causes • Hospitalization rate with a primary diagnosis of respiratory disease or respiratory infection • Hospitalization rate with a primary diagnosis of cardiovascular disease • Rate of an incident diagnosis of cardiovascular disease Self-reported data collected at 3 months: • Self-rated oxygen utilization • Breathlessness (Multidimensional Dyspnea Profile; MDP) • Fatigue (FACIT-Fatigue) • Informant-based cognitive questionnaire (IQCODE) • Cognition (IQCODE-SR and BAS) • Health-related quality of life (CAT and EQ5D-5L) • Global impression of change from baseline (GIC) • Self-reported physical activity • Preference of continuing treatment;Timepoint(s) of evaluation of this end point: At 3 and 12 months

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Countries

Sweden

Contacts

Public ContactMagnus Ekström

Blekinge county council

pmekstrom@gmail.com+46739966612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026