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    Clinical Trial Results:
    Will titrated oxygen flow to a peripheral oxygen saturation of 88-92% compared with oxygen flow to a saturation >94% reduce mortality in Chronic Obstructive Pulmonary Disease patients with acute exacerbation? – a randomized clinical trial

    Summary
    EudraCT number
    		 2019-002498-80
    Trial protocol
    		 DK  
    Global end of trial date
    12 Nov 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Nov 2025
    First version publication date
    28 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    06062019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05052125
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospital of South West Denmark
    Sponsor organisation address
    Finsensgade 35, Esbjerg, Denmark,
    Public contact
    Mikkel Brabrand, Research Unit in Emergency Medicine, SVS, 0045 40736373,
    Scientific contact
    Mikkel Brabrand, Research Unit in Emergency Medicine, SVS, 0045 40736373,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Nov 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine if titrated supplementary oxygen treatment to a low peripheral oxygen saturation initiated at arrival to the emergency department is superior to supplementary oxygen treatment titrated to a high peripheral oxygen saturation in reducing 30-day all-cause mortality in acutely admitted patients with COPD exacerbation.
    Protection of trial subjects
    Close follow-up by study nurses.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    15
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened by study nurses and offered inclusion if they fulfilled the criteria in the ED.

    Pre-assignment
    Screening details
    		 Patients were screned on arrival to the ED and included within 30 minutes by study nurses if they fulfilled the criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Target peripheral oxygen saturation of 88-92%
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Titrated to desired peripheral oxygen saturation

    Arm title
    		 Control
    Arm description
    		 Control
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Titrated to desired peripheral oxygen saturation

    Number of subjects in period 1
    		Intervention Control
    Started
    12
    11
    Completed
    12
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 75 (68 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 9 9
    COPD diagnosis on inclusion
    Did the patient have a COPD diagnosis registered at time of inclusion
    Units: Subjects
        Yes
    		 23 23
        No
    		 0 0
        Unknown
    		 0 0
    Transportion time
    Time spent on transportion to hospital via ambulance
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 29 (15 to 30) -
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysis according to randomisation

    Subject analysis sets values
    		 Intention-to-treat analysis
    Number of subjects
    23
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    75 (68 to 84)
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    9
    COPD diagnosis on inclusion
    Did the patient have a COPD diagnosis registered at time of inclusion
    Units: Subjects
        Yes
    23
        No
    0
        Unknown
    0
    Transportion time
    Time spent on transportion to hospital via ambulance
    Units: minute
        median (inter-quartile range (Q1-Q3))
    29 (15 to 30)

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Target peripheral oxygen saturation of 88-92%

    Reporting group title
    Control
    Reporting group description
    		 Control

    Subject analysis set title
    Intention-to-treat analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysis according to randomisation

    Primary: 30-day all-cause mortality

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    End point title
    		 30-day all-cause mortality
    End point description
    End point type
    Primary
    End point timeframe
    30-days after inclusion
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: Patients
        Alive at 30 days
    12
    8
        Dead at 30 days
    0
    3
    Statistical analysis title
    		 Fischers exact test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.093
    Method
    		 Fisher exact
    Confidence interval

    Secondary: 7-day all-cause mortality

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    End point title
    		 7-day all-cause mortality
    End point description
    End point type
    Secondary
    End point timeframe
    7 days after inclusion
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: Patients
        Alive at 7 days
    12
    10
        Dead at 7 days
    0
    1
    Statistical analysis title
    		 Fischers exact test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.478
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Non-invasive ventilation

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    End point title
    		 Non-invasive ventilation
    End point description
    End point type
    Secondary
    End point timeframe
    During hospital admission
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: Patients
        Received non-invasive ventilation
    1
    1
        Did not receive non-invasive ventilation
    11
    10
    Statistical analysis title
    		 Fischers exact test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Admission to intensive care

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    End point title
    		 Admission to intensive care
    End point description
    End point type
    Secondary
    End point timeframe
    During hospital admission
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: Patients
        Admitted to intensive care
    0
    1
        Not admitted to intensive care
    12
    10
    Statistical analysis title
    		 Fischers exact test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.478
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Intubated during admission

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    End point title
    		 Intubated during admission
    End point description
    End point type
    Secondary
    End point timeframe
    During hospital admission
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: Patients
        Intubated
    0
    0
        Not intubated
    12
    11
    No statistical analyses for this end point

    Secondary: Length of hospital admission

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    End point title
    		 Length of hospital admission
    End point description
    End point type
    Secondary
    End point timeframe
    Total length of hospital stay
    End point values
    		 Intervention Control
    Number of subjects analysed
    12
    11
    Units: day
        median (inter-quartile range (Q1-Q3))
    4.0 (2.1 to 4.3)
    3.1 (3.0 to 7.0)
    Statistical analysis title
    		 T-test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.179
    Method
    		 t-test, 2-sided
    Confidence interval

    Other pre-specified: Systemic oxydative stress level (8-isopropane)

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    End point title
    		 Systemic oxydative stress level (8-isopropane)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 hours after inclusion
    End point values
    		 Intervention Control
    Number of subjects analysed
    8
    9
    Units: picogram(s)
        median (inter-quartile range (Q1-Q3))
    19.1 (14.75 to 44.75)
    16 (5.4 to 16.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Systemic inflammation level (IL-8)

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    End point title
    		 Systemic inflammation level (IL-8)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 hours after inclusion
    End point values
    		 Intervention Control
    Number of subjects analysed
    8
    9
    Units: picogram(s)
        median (inter-quartile range (Q1-Q3))
    30.55 (8.55 to 55.45)
    24.2 (11.4 to 42.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 hours after inclusion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    Hypotension
    Reporting group description
    		 -

    Serious adverse events
    		 Hypotension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Hypotension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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