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

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ClinicalTrials.gov Identifier: NCT03441204
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Blekinge County Council Hospital
Information provided by (Responsible Party):
Magnus Ekström, Skane University Hospital

Brief Summary:
Multicenter, phase IV, 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: LTOT 24 h/day Drug: LTOT 15h/day Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REgistry-based Randomized Controlled Trial of Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX) A Multicenter, Phase IV, Registry-Based, Randomized Controlled Trial (R-RCT)
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: LTOT 24 h/day (intervention)
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 prescribed for 24 h/day.
Other Name: Long-term oxygen therapy prescribed continuously (24 h/day)

Active Comparator: LTOT 15 h/day (control)
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
: 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.
Other Name: Long-term oxygen therapy prescribed for 15 h/day




Primary Outcome Measures :
  1. All-cause mortality rate [ Time Frame: 1 year ]
    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 all-cause mortality at 1 year.


Secondary Outcome Measures :
  1. All-cause mortality rate [ Time Frame: 3 months ]
    Between-group difference in deaths from all causes

  2. Mortality rate from respiratory disease [ Time Frame: 3 months and 12 months ]
    Between-group difference in deaths from respiratory disease

  3. Mortality rate from cardiovascular disease [ Time Frame: 3 months and 12 months ]
    Between-group difference in deaths from cardiovascular disease

  4. Hospitalization rate from all causes [ Time Frame: 3 months and 12 months ]
    Between-group difference in hospitalization rate from all causes

  5. Hospitalization rate with a primary diagnosis of respiratory disease [ Time Frame: 3 months and 12 months ]
    Between-group difference in hospitalization rate with a primary diagnosis of respiratory disease

  6. Hospitalization rate with a primary diagnosis of cardiovascular disease [ Time Frame: 3 months and 12 months ]
    Between-group difference in hospitalization rate with a primary diagnosis of cardiovascular disease

  7. Rate of an incident diagnosis of cardiovascular disease [ Time Frame: 3 months and 12 months ]
    Between-group difference in rate of an incident diagnosis of cardiovascular disease

  8. Self-reported questionnaire data on oxygen use [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on self-reported oxygen utilization (group percentages)

  9. Self-reported questionnaire data on oxygen side effects [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on side effects of oxygen (group percentages)

  10. Self-reported questionnaire data on physical activity [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on self-reported physical activity (group percentages)

  11. Self-reported questionnaire data on LTOT continuation [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on preference of continuing the LTOT (group percentages)

  12. Self-reported questionnaire data on breathlessness (MDP scale) [ Time Frame: 3 months and 12 months ]

    Between-group difference in data from postal questionnaire on breathlessness; Multidimensional Dyspnea Profile (MDP) scale. One item (A1) assesses the unpleasantness of dyspnoea on a 0-10 visual numerical scale anchored by "neutral" (0) and "unbearable" (10). Five items assess the sensory dimension of dyspnoea, both in terms of quality and intensity (on a scale of 0-10). Five items assess the affective dimension of dyspnoea, also in terms of quality and intensity (on a scale of 0-10).

    Two domain scores are calculated: an "immediate perception domain" score (S) as the sum of A1 intensity and the intensities of the five sensory descriptors; and an "emotional response domain" score (A2) as the sum of the five emotional descriptors. The median (IQR) ratings will be compared betwwen the groups.


  13. Self-reported questionnaire data on breathlessness (mMRC scale) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on breathlessness; modified Medical Research Council (mMRC) scale. measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness and 5 worse breathlessness. Percentages and mean scores are reported.

  14. Self-reported questionnaire data on fatigue (FACIT-Fatigue) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on fatigue; Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale is a 13 item questionnaire measured on a 4‐point Likert scale (0 = not at all; 4 = very much). All items are summed to create a single fatigue total score with a range from 0 to 52, where higher scores indicate better functioning or less fatigue.

  15. Self-reported questionnaire data on cognition (IQCODE-SR scale) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on cognition self-report; Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE-SR) consists of 16-items (score range, 1.0-5.0; where 1=much better and 5=much worse). Total score is used.

  16. Self-reported questionnaire data on HRQOL (CAT) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on HRQOL; COPD Assessment test (CAT) consists of 8 items; 0-5 scale with higher scores indicating worse outcome and total scores ranging between 0 and 40. Mean scores are reported.

  17. Self-reported questionnaire data on HRQOL (EQ-5D-5L) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire on HRQOL; EuroQol five-dimensional descriptive system (EQ-5D-5L) describing health on the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores are graded into 'no problems', 'slight problems', 'moderate problems', 'severe problems' and 'extreme problems/unable to. Mean scores are reported.

  18. Self-reported questionnaire data on treatment response (GIC) [ Time Frame: 3 months and 12 months ]
    Between-group difference in data from postal questionnaire; Global impression of change (GIC) is a 7-point descriptive scale: ranging from 1 to 7 with 1 being very much improved and 7 very much worse. Mean scores are reported.

  19. Measured Oxygen utilization [ Time Frame: 12 months ]
    Between-group difference in measured Oxygen utilization up to 1 year (flow sensors on stationary and portable oxygen equipment) according to funding

  20. Health care utilization [ Time Frame: 3 months and 12 months ]
    Between-group difference in number of hospitalizations; number of outpatient visits and Emergency Department visits and Other medication use and cost through national registries (National Inpatient Register; National Outpatient Care Register; National Patient Register; Prescribed Drug Register)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 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: Verified COPD (FEV1/FVC < 0.7 after bronchodilation) with severe resting hypoxemia (PaO2 < 7.4 kPa or oxygen saturation < 88% breathing air) when starting LTOT.
  • Secondary analyses:

    1. Interstitial Lung Disease (ILD) as main reason for starting LTOT with severe hypoxemia (PaO2 < 7.4 kPa or oxygen saturation < 88% breathing air) at LTOT start
    2. Participants with moderate hypoxemia (PaO2 on air 7.4−8.0 kPa) at LTOT start by diagnosis and as a discrete group
    3. All participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441204


Contacts
Contact: Magnus Ekström, MD, PhD +46 455 pmekstrom@gmail.com
Contact: Ylva Lindman +4618611 7680 ylva.lindman@ucr.uu.se

Locations
Sweden
Blekinge hospital Recruiting
Karlskrona, Blekinge, Sweden, SE-37185
Contact: Magnus Ekström, MD       pmekstrom@gmail.com   
Örebro University Hospital Recruiting
Örebro, Sweden, SE-70185
Contact: Josefin Sundh, MD       josefin.sundh@regionorebrolan.se   
Sponsors and Collaborators
Skane University Hospital
Blekinge County Council Hospital
Investigators
Principal Investigator: Magnus Ekström, MD, PhD Blekinge County Council Hospital

Additional Information:
Publications:
Responsible Party: Magnus Ekström, Principal Investigator, Skane University Hospital
ClinicalTrials.gov Identifier: NCT03441204     History of Changes
Other Study ID Numbers: REDOX 2016
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Magnus Ekström, Skane University Hospital:
COPD
Long-term oxygen therapy (LTOT)
Registry
Registry-based randomized controlled trial (R-RCT)
Treatment duration
Mortality

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases