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    Clinical Trial Results:
    High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine

    Summary
    EudraCT number
    		 2016-000354-35
    Trial protocol
    		 DK  
    Global end of trial date
    01 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Oct 2017
    First version publication date
    29 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2016-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul Jensens Blv 100, Aarhus, Denmark, 8200
    Public contact
    Paediatric Department, Aarhus University Hospital, +45 78451471, anjor@clin.au.dk
    Scientific contact
    Paediatric Department, Aarhus University Hospital, +45 78451471, anjor@clin.au.dk
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul Jensens blv 100, Aarhus N, Denmark, 8200
    Public contact
    Pediatric Department, Arhus University Hospital, 0045 78450000, anjor@clin.au.dk
    Scientific contact
    Pediatric Department , Aarhus University Hospital, 0045 78451471, anjor@clin.au.dk
    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
    25 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to evalutate if high dose antioxidant treatment ( per oral) of cystic fibrosis patients can inhibit the oxaditive stress mediated inflammation in their lungs-Measured by concentration of desmosine/isodesmosine in the urine
    Protection of trial subjects
    To minimize pain in relation to blood sampling the patients were offered local anestestics or inhalation with 50% N2O +50% O2. No other measures were taken
    Background therapy
    		 Pancreatic enzymes -vitamin supplementation- PEP mask theraphy- pulmozyme inhalation
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2016
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    26
    Adolescents (12-17 years)
    14
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were contacted during rutine control visits in the outpatient Clinic an asked if they wanted to participate.Recruitement period June 2016-October 2016

    Pre-assignment
    Screening details
    		 41 patients were screened. One produced pseudomonas aeruginosa positive sputum culture during the investigation period and had to be excluded.

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baseline
    Arm description
    		 7 days without any antiinflammatory treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 medical intervention
    Arm description
    		 Pts. recieved 7 days N-acetyl cysteine 100 mg/kg/ in 3 doses + after that 7 days N-acetylcysteine 200mg/kg/in 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    N-acetylcysteine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    7 days with 100mg/kg/ 24 hrs in 3 divided doses followed by 7 days with 200 mg /kg/24 hrs in 3 divided doses

    Number of subjects in period 1
    		Baseline medical intervention
    Started
    20
    20
    Completed
    20
    20
    Period 2
    Period 2 title
    medical intervention
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 baseline
    Arm description
    		 7 days with no antiinflammatory treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		baseline
    Started
    40
    Completed
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 7 days without any antiinflammatory treatment

    Reporting group title
    medical intervention
    Reporting group description
    		 Pts. recieved 7 days N-acetyl cysteine 100 mg/kg/ in 3 doses + after that 7 days N-acetylcysteine 200mg/kg/in 3 doses.

    Reporting group values
    		 Baseline medical intervention Total
    Number of subjects
    		 20 20 40
    Age categorical
    children 2-11: 13 adolescents 12-17: 7
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 13 13 26
        Adolescents (12-17 years)
    		 7 7 14
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        children
    		 0 0 0
        adolescents
    		 0 0 0
    Gender categorical
    female:9 Male: 11
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 11 11 22
    Subject analysis sets

    Subject analysis set title
    Pre treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A spot urine was taken at day 7 and 21 - and analyses for desmosine/isodesmosine was carried out and related to urine creatinin values

    Subject analysis set title
    Post treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A spot urine was taken at day 7 and 21 - and analyses for desmosine/isodesmosine was carried out and related to urine creatinin values

    Subject analysis sets values
    		 Pre treatment Post treatment
    Number of subjects
    20
    20
    Age categorical
    children 2-11: 13 adolescents 12-17: 7
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    13
    13
        Adolescents (12-17 years)
    7
    7
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        children
    0
    0
        adolescents
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    female:9 Male: 11
    Units: Subjects
        Female
    9
    9
        Male
    11
    11

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 7 days without any antiinflammatory treatment

    Reporting group title
    medical intervention
    Reporting group description
    		 Pts. recieved 7 days N-acetyl cysteine 100 mg/kg/ in 3 doses + after that 7 days N-acetylcysteine 200mg/kg/in 3 doses.
    Reporting group title
    baseline
    Reporting group description
    		 7 days with no antiinflammatory treatment

    Subject analysis set title
    Pre treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A spot urine was taken at day 7 and 21 - and analyses for desmosine/isodesmosine was carried out and related to urine creatinin values

    Subject analysis set title
    Post treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A spot urine was taken at day 7 and 21 - and analyses for desmosine/isodesmosine was carried out and related to urine creatinin values

    Primary: change in urine desmosine/isodesmosine excretion

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    End point title
    		 change in urine desmosine/isodesmosine excretion
    End point description
    Spot Urine samples were analysed for desmosine/isodesmosine in ng /ml and related to urine creatinine in mg/ml - making values in ng/mg
    End point type
    Primary
    End point timeframe
    Measurements were made day 7 and 14
    End point values
    		 Baseline medical intervention Pre treatment Post treatment
    Number of subjects analysed
    20
    20
    20
    20
    Units: ng/mg
        median (full range (min-max))
    52.4 (32.9 to 100.6)
    50.15 (16.3 to 82.7)
    52.4 (32.9 to 100.6)
    50.15 (16.3 to 82.7)
    Statistical analysis title
    		 Wilcoxon signed rank test
    Statistical analysis description
    Median and range for values from day 7- and day 14 were calculated and a Wilcoxon signed rank test was calculated between day 7 values and day 14 values
    Comparison groups
    Pre treatment v Post treatment
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.95
    Variability estimate
    Standard error of the mean
    Notes
    [1] - values from 20 patients at day 7 are compared to 20 treated patients values at day 14
    [2] - No significant differences were found

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    28 days
    Adverse event reporting additional description
    clinical examination and anamnestic review at all 4 clinical visits,blood tests
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Frequency threshold for reporting non-serious adverse events: 1%
    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: No non-serious adverse effects were observed

    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
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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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