Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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%

    Close Top of page
    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

    Close Top of page
    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]

    Close Top of page
    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) (%)

    Close Top of page
    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)

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page

    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
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA