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

NCT03441204 | Completed Phase 4

• 1 other identifier: REDOX 2016
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

COPD; Long-term oxygen therapy (LTOT); Registry; Registry-based randomized controlled trial (R-RCT); Treatment duration; Mortality

Outcome Measures

Primary Outcomes (1)

• All-cause hospitalization or mortality rate

  To determine whether oxygen prescribed 24 h/day compared with 15 h/day in patients with chronic obstructive pulmonary disease (COPD) and severe hypoxemia improves the rate of all-cause hospitalization or mortality at 1 year.

  1 year

Secondary Outcomes (18)

• All-cause mortality rate

  3 months and 12 months

• Mortality rate from respiratory disease

  3 months and 12 months

• Mortality rate from cardiovascular disease

  3 months and 12 months

• Hospitalization rate from all causes

  3 months and 12 months

• Hospitalization rate with a primary diagnosis of respiratory disease

  3 months and 12 months

Study Arms (2)

LTOT 24 h/day (intervention)

ACTIVE COMPARATOR

Long-term oxygen therapy (LTOT) prescribed 24 h/day. The LTOT is provided according to standard clinical practice using oxygen concentrator, cylinders or liquid oxygen and administered mainly through nasal prongs. The oxygen dose (l/min) is titrated aiming at a PaO2 on oxygen \> 8 kPa in accordance with current routine practice and management guidelines.

Drug: LTOT 24 h/day

LTOT 15 h/day (control)

ACTIVE COMPARATOR

Long-term oxygen therapy (LTOT) prescribed 15 h/day. The LTOT is provided according to standard clinical practice using oxygen concentrator, cylinders or liquid oxygen and administered mainly through nasal prongs. The oxygen dose (l/min) is titrated aiming at a PaO2 on oxygen \> 8 kPa in accordance with current routine practice and management guidelines.

Drug: LTOT 15h/day

Interventions

LTOT 24 h/day DRUG

LTOT prescribed for 24 h/day.

Also known as: Long-term oxygen therapy prescribed continuously (24 h/day)

LTOT 24 h/day (intervention)

LTOT 15h/day DRUG

: 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.

Also known as: Long-term oxygen therapy prescribed for 15 h/day

LTOT 15 h/day (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Severe resting hypoxemia (PaO2 \< 7.4 kPa or oxygen saturation \< 88% breathing air), or PaO2 \< 8.0 kPa on air and either signs of heart failure or polycythemia (EVF \> 0.54).

You may not qualify if:

• Smoking or contact with open fire
• Other inability to safely comply with LTOT
• Already on LTOT for more than 28 days
• Inability to comply with any of the study interventions 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.
• Patient populations that will be evaluated:
• Primary analysis: In all randomized patients according to the intention-to-treat and per protocol principles.
• Secondary analyses: In patients with 1) PaO2 (air) \< 7.4 kPa; 2) PaO2 (air) 7.4 to 8.0 kPa; 3) COPD verified by spirometry (COPD as primary diagnosis and FEV1/FVC \< 0.7 after bronchodilation); 4) and in patients with a primary diagnosis other than COPD.

Sponsors & Collaborators

• Skane University Hospital: lead
• Lund University: collaborator
• Blekinge County Council Hospital: collaborator

Study Sites (2)

Blekinge hospital

Karlskrona, Blekinge County, SE-37185, Sweden

Location

Örebro University Hospital

Örebro, SE-70185, Sweden

Location

Related Publications (6)

• Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

  PMID: 6776858 BACKGROUND

• Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

  PMID: 6110912 BACKGROUND

• Anthonisen NR. Prognosis in chronic obstructive pulmonary disease: results from multicenter clinical trials. Am Rev Respir Dis. 1989 Sep;140(3 Pt 2):S95-9. doi: 10.1164/ajrccm/140.3_Pt_2.S95. No abstract available.

  PMID: 2675713 BACKGROUND

• Hardinge M, Annandale J, Bourne S, Cooper B, Evans A, Freeman D, Green A, Hippolyte S, Knowles V, MacNee W, McDonnell L, Pye K, Suntharalingam J, Vora V, Wilkinson T; British Thoracic Society Home Oxygen Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015 Jun;70 Suppl 1:i1-43. doi: 10.1136/thoraxjnl-2015-206865.

  PMID: 25870317 BACKGROUND

• Ekstrom M, Andersson A, Papadopoulos S, Kipper T, Pedersen B, Kricka O, Sobrino P, Runold M, Palm A, Blomberg A, Hamed R, Lindberg E, Sundberg B, Hadziosmanovic N, Bjorklund F, Janson C, McDonald CF, Currow DC, Sundh J; REDOX Collaborative Research Group. Long-Term Oxygen Therapy for 24 or 15 Hours per Day in Severe Hypoxemia. N Engl J Med. 2024 Sep 19;391(11):977-988. doi: 10.1056/NEJMoa2402638. Epub 2024 Sep 10.

  PMID: 39254466 DERIVED

• Sundh J, Bornefalk-Hermansson A, Ahmadi Z, Blomberg A, Janson C, Currow DC, McDonald CF, McCaffrey N, Ekstrom M. REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol. BMC Pulm Med. 2019 Feb 26;19(1):50. doi: 10.1186/s12890-019-0809-7.

  PMID: 30808321 DERIVED

Related Links

• Swedish National Register for Respiratory Failure (Swedevox). Annual report. 2014. \[Accessed 19 February 2016\]

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magnus Ekström, MD, PhD

  Blekinge County Council Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 22, 2018
• Study Start: May 16, 2018
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2023
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)