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    Clinical Trial Results:
    Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - Randomised, double-blind, placebo-controlled cohort trial

    Summary
    EudraCT number
    		 2014-003581-25
    Trial protocol
    		 DE  
    Global end of trial date
    14 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2021
    First version publication date
    11 Nov 2021
    Other versions
    Summary report(s)
    		 Adverse Events information_APAIII
    Primary endpoint statitical analysis

    Trial information

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    Trial identification
    Sponsor protocol code
    APA-III
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Tübingen
    Sponsor organisation address
    Geissweg 3, Tübingen, Germany, 72076
    Public contact
    Dr.med. Andreas Hector, University Children's Hospital, CPCS, +49 70712981341, andreas.hector@med.uni-tuebingen.de
    Scientific contact
    Dr.med. Andreas Hector, University Children's Hospital, CPCS, +49 70712981341, andreas.hector@med.uni-tuebingen.de
    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 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Difference in absolute FEV1 % predicted between verum and placebo at week 8 compared to baseline
    Protection of trial subjects
    Patient's safety and well-being was taken in consideration during the whole procedure of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2015
    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
    Germany: 79
    Worldwide total number of subjects
    79
    EEA total number of subjects
    79
    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)
    10
    Adults (18-64 years)
    66
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 According to study protocol recruitment was planned to start in March 2015 and to be done within 18 months. Number of cases, statistical considerations, a total of 102 patients had to be included in this study (refer to study protocol chapter 9.1). The last follow-up included into this report took place on June 8th, 2018.

    Pre-assignment
    Screening details
    		 As already mentioned hardly any data are documented concerning the pre-screening process and therefore the reasons, why patients could not be screened for the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was done double blinded (patients and treating physicians) but due to the known side effects of amitriptyline it must be feared that physicians as well as patients knew which treatment they got.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amitriptyline arm
    Arm description
    		 Amitriptyline
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amitriptyline
    Investigational medicinal product code
    549-18-8
    Other name
    Elavil
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Amitriptyline 2 x 12.5 mg oral (day 1-14), followed by 2x25mg twice daily (day 15-98).

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (corn starch)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo (corn starch) 2 x 12.5 mg oral (day 1-14), followed by 2x25mg twice daily (day 15-98)

    Number of subjects in period 1
    		Amitriptyline arm Placebo arm
    Started
    42
    37
    Completed
    36
    34
    Not completed
    6
    3
         Lost to follow-up
    2
    1
         Protocol deviation
    4
    2

    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
    		 79 79
    Age categorical
    The median age was 24 years. The mininum age was 13 years and the maximum was 68
    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)
    		 0 0
        Adolescents (12-17 years)
    		 19 19
        Adults (18-64 years)
    		 59 59
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 45 45

    End points

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    End points reporting groups
    Reporting group title
    Amitriptyline arm
    Reporting group description
    		 Amitriptyline

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Primary: Difference between baseline and week 8 in FEV1%

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    End point title
    		 Difference between baseline and week 8 in FEV1% [1]
    End point description
    Difference in absolute FEV1 % predicted between verum and placebo at week 8 compared to baseline
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses can be found in the attached chart
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    42
    37
    Units: 40
        arithmetic mean (standard deviation)
    -2.23 ( 9.64 )
    -1.34 ( 6.85 )
    Attachments
    		 Primary endpoint statitical analysis
    No statistical analyses for this end point

    Secondary: Absolute and relative FEV1 as 2. Absolute and relativeFEV1 as % predicted after 4, 8 and 16 weeks compared tobaseline, if not primary

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    End point title
    		 Absolute and relative FEV1 as 2. Absolute and relativeFEV1 as % predicted after 4, 8 and 16 weeks compared tobaseline, if not primary
    End point description
    Absolute and relative FEV1 as 2. Absolute and relative FEV1 as % predicted after 4, 8 and 16 weeks compared to baseline, if not primary
    End point type
    Secondary
    End point timeframe
    between week 8 and week 16
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    42
    37
    Units: 40
        arithmetic mean (standard deviation)
    66.71 ( 19.31 )
    64.67 ( 21.65 )
    No statistical analyses for this end point

    Secondary: FEV1 [L]

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    End point title
    		 FEV1 [L]
    End point description
    Absolute and relative FEV1 increase
    End point type
    Secondary
    End point timeframe
    Until study termination (20 weeks)
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    42
    37
    Units: 40
        arithmetic mean (standard deviation)
    2.37 ( 0.79 )
    2.42 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Other lung function parameters (FVC) (%)

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    End point title
    		 Other lung function parameters (FVC) (%)
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    42
    37
    Units: 40
        arithmetic mean (standard deviation)
    82.52 ( 18.23 )
    85.05 ( 18.10 )
    No statistical analyses for this end point

    Secondary: Other lung function parameters (FVC) (L)

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    End point title
    		 Other lung function parameters (FVC) (L)
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    42
    37
    Units: 40
        arithmetic mean (standard deviation)
    3.39 ( 1.05 )
    3.73 ( 0.95 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The trial duration and the follow up period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Information regarding Adverse Events can be found in the attached documents

    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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    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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