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    Clinical Trial Results:
    Randomised, controlled crossover trial to evaluate the Effects of Ambulatory Oxygen on health status in patients with Fibrotic Lung Disease (FLD)

    Summary
    EudraCT number
    		 2013-004355-20
    Trial protocol
    		 GB  
    Global end of trial date
    15 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2019
    First version publication date
    17 Oct 2019
    Other versions
    Summary report(s)
    		 AmbOxy Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    2013OE005B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Brompton and Harefield NHS Foundation Trust
    Sponsor organisation address
    Sydney Street, LONDON, United Kingdom,
    Public contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust , 44 2073518109, i.jakupovic@rbht.nhs.uk
    Scientific contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust , 44 2073518109, i.jakupovic@rbht.nhs.uk
    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
    20 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main symptom that occurs in fibrotic lung disease (lung scarring) is breathlessness due to the progressive scarring of the lungs, with a profound impact on daily activities. During exercise, lung fibrosis is often associated with a drop in oxygen saturation which can be corrected by the use of supplemental oxygen. In patients with lung scarring, the main cause of overall worsening quality of life is breathlessness. The principal research question is the study of the impact of supplemental oxygen on health status. We strongly believe that attempts to improve or maintain health status are of crucial importance, especially in this group of respiratory diseases, characterized overall by a poor prognosis and progressive worsening in quality of life.
    Protection of trial subjects
    SAEs were monitored by IDMC
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 84
    Worldwide total number of subjects
    84
    EEA total number of subjects
    84
    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)
    28
    From 65 to 84 years
    55
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 269 subjects were screened; 171 excluded; 125 ineligible and 46 declined; 98 completed screening visit;

    Period 1
    Period 1 title
    Randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Oxygen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Cylinders weight range 1.8-2.2 kg

    Arm title
    		 Non-Oxygen
    Arm description
    		 -
    Arm type
    		 comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Oxygen Non-Oxygen
    Started
    41
    43
    Completed
    37
    39
    Not completed
    4
    4
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 84 84
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 28 28
        From 65-84 years
    		 55 55
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 58 58

    End points

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    End points reporting groups
    Reporting group title
    Oxygen
    Reporting group description
    		 -

    Reporting group title
    Non-Oxygen
    Reporting group description
    		 -

    Primary: K-BILD score

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    End point title
    		 K-BILD score
    End point description
    End point type
    Primary
    End point timeframe
    At the end of the cross over.
    End point values
    		 Oxygen Non-Oxygen
    Number of subjects analysed
    37
    39
    Units: 00.00
    37
    39
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    For the primary outcome, a generalised linear model was used with the difference in HRQOL as the dependent variable and treatment sequence as a fixed effect. An adjustment was made for the order of treatment. Th e same method was used to analyse the secondary outcomes. Conditional logistic regression, with sequence as an interaction term, was used to analyse the effects of oxygen on the presence of anxiety or depression. All the analysis was by intention to treat. Significance was at p < 0.05
    Comparison groups
    Oxygen v Non-Oxygen
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 generalised linear model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 5.6
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    within 24 hours of their becoming aware of the event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Oxygen
    Reporting group description
    		 -

    Reporting group title
    No Oxygen
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This study was based on utilizing routine standard of care in this patient group, and the design was based on cross over, ensuring that patients in both arms received ambulatory oxygen and the time of being in the relevant study arm. While the Sponsor had requested recording of non-serous adverse events in patient notes, we have only collected SAEs for this study.
    Serious adverse events
    		 Oxygen No Oxygen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 43 (6.98%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Angina
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chest infection
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Oxygen No Oxygen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 43 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2015
    - Changes to the study protocol to address the issues highlighted during monitoring visits - PIS and ICF changed to ensure consistency with the study protocol REC FAO 13.01.2015 MHRA Approval 19.01.2015
    09 Nov 2015
    - The Substantial Amendment proposes to add a new site to the study: North Bristol NHS Trust, PI Dr Huzaifa Adamali REC FAO 09.11.2015

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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