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    Clinical Trial Results:
    Modulation of lung injury complicating lung resection

    Summary
    EudraCT number
    		 2006-004442-16
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2020
    First version publication date
    19 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    cro524
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00655928
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensingston Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Mark J Griffiths, Imperial College London, +44 020 7351 8523, m.griffiths@imperial.ac.uk
    Scientific contact
    Mark J Griffiths, Imperial College London, +44 020 7351 8523, m.griffiths@imperial.ac.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
    01 Jul 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate whether it is possible to reduce the amount of lung injury/inflammation caused by one-lung ventilation during lung surgery by giving an antioxidant, acetylcysteine, prior to surgery.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2007
    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
    United Kingdom: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    40
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adults undergoing elective lung resection for cancer at the Royal Brompton Hospital, London, UK were eligible. Recruitment was between Aug 2008 and July 2009.

    Pre-assignment
    Screening details
    		 90 participants were assessed for eligibility, excluded 38 participants and randomised 52.

    Period 1
    Period 1 title
    Randomization
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Randomization period
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 N-acetylcysteine (NAC)
    Arm description
    		 Randomization period
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Placebo N-acetylcysteine (NAC)
    Started
    26
    26
    Completed
    24
    23
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    1
         Physician decision
    1
    2
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 N-acetylcysteine (NAC)
    Arm description
    		 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)
    Arm type
    		 Experimental

    Investigational medicinal product name
    N-acetylcysteine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Preoperative infusion of N-acetylcysteine, 240 mg/kg in 1000 mL 0.9% saline over 12 h.

    Arm title
    		 Placebo
    Arm description
    		 Eligible adults were randomized to receive preoperative infusion of placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Preoperative infusion of 1000 mL 0.9% saline over 12 h.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The group of participants who actually received the allocated treatment.
    Number of subjects in period 2 [2]
    		N-acetylcysteine (NAC) Placebo
    Started
    23
    24
    Completed
    23
    24
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The group of participants who actually received the allocated treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    N-acetylcysteine (NAC)
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of placebo.

    Reporting group values
    		 N-acetylcysteine (NAC) Placebo Total
    Number of subjects
    		 23 24 47
    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
        geometric mean (standard deviation)
    		 68 ( 10.1 ) 63.8 ( 11.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 17
        Male
    		 15 15 30
    Spirometry, FEV1
    Units: litres
        arithmetic mean (standard deviation)
    		 2.23 ( 0.97 ) 2.56 ( 0.81 ) -
    Duration of one-lung ventilation
    Measure Description: One lung ventilation is a process that refers to mechanical separation of the two lungs to allow ventilation of only one lung, while the other lung is compressed by the surgeon or allowed to passively deflate.
    Units: minutes
        geometric mean (standard deviation)
    		 134 ( 42 ) 137 ( 59 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomization period

    Reporting group title
    N-acetylcysteine (NAC)
    Reporting group description
    		 Randomization period
    Reporting group title
    N-acetylcysteine (NAC)
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of placebo.

    Primary: Post-operative Plasma IL-6

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    End point title
    		 Post-operative Plasma IL-6
    End point description
    Plasma IL-6 was measured in duplicate using ELISA
    End point type
    Primary
    End point timeframe
    Post operative, 24 hours
    End point values
    		 N-acetylcysteine (NAC) Placebo
    Number of subjects analysed
    23
    24
    Units: pg/ml
        geometric mean (inter-quartile range (Q1-Q3))
    126 (80 to 180)
    111 (72 to 162)
    Statistical analysis title
    		 IL 6
    Comparison groups
    N-acetylcysteine (NAC) v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    N-acetylcysteine (NAC)
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible adults were randomized to receive preoperative infusion of placebo.

    Serious adverse events
    		 N-acetylcysteine (NAC) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 23 (60.87%)
    12 / 24 (50.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Acut lung injury
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Postoperative complication
         subjects affected / exposed
    13 / 23 (56.52%)
    10 / 24 (41.67%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 N-acetylcysteine (NAC) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 23 (34.78%)
    5 / 24 (20.83%)
    Infections and infestations
    Respiratory infection
         subjects affected / exposed
    6 / 23 (26.09%)
    3 / 24 (12.50%)
         occurrences all number
    6
    3
    Wound infection
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Pleural fluid infection
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Intravascular cannula infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26503312
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    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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