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    Clinical Trial Results:
    Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo

    Summary
    EudraCT number
    		 2008-002673-13
    Trial protocol
    		 DE  
    Global end of trial date
    01 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    APA-IIb
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01309178
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Tübingen
    Sponsor organisation address
    Geissweg 3, Tübingen, Germany, 72076
    Public contact
    Prof. Dr. med. M. Bamberg, University Hospital Tübingen, +49 7071 29-88500 ,
    Scientific contact
    Dr. med. Joachim Riethmüller, University Hospital Tübingen, +49 (0)7071-2981391,
    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
    Interim
    Date of interim/final analysis
    01 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the improvement of the lung function parameter FEV1 (absolute and relative to baseline) under verum and placebo in 4 weeks
    Protection of trial subjects
    The written permission for use of the personal and study-related data and passing it on in pseudo-anonymous form will be done before the study starts. The patients’ parents have to give their consent on behalf of their child for this data to be used within a scientific study. If no such consent is given, the data must not be used. Only those persons involved in the clinical trial will have access to the personal data and to the patient identification list.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2009
    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
    Germany: 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)
    0
    Adolescents (12-17 years)
    40
    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
    		 The study is scheduled to begin on November 1st 2008. The first patient should be treated not before spring 2009. The maximal duration of the study will be 12 months. The individual participation on the study will be at least 6 weeks.

    Pre-assignment
    Screening details
    		 95 patients were assessed for eligibility. 55 of them were excluded because they did not meet the inclusion and exclusion criteria. Therefore, 40 patients underwent randomization. Out of the 40 patients, 37 were included in the ITT analysis.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amitriptyline arm
    Arm description
    		 Patients were randomized to amitriptyline capsules, administered orally at a dosage of 25 mg amitriptyline per capsule, twice daily for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amitriptyline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg amitriptyline per capsule, twice daily for 4 weeks

    Arm title
    		 Placebo arm
    Arm description
    		 the placebo were corn starch capsules administered in the same frequency as the experimental drug
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Corn starch capsules twice daily during 4 weeks

    Number of subjects in period 1
    		Amitriptyline arm Placebo arm
    Started
    21
    19
    Completed
    19
    17
    Not completed
    2
    2
         High c-protein reactive values
    1
    -
         high c-reactive protein levels
    -
    1
         missing values
    1
    1

    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
    		 40 40
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 15 15
        Adults (18-64 years)
    		 25 25
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.5 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Amitriptyline arm
    Reporting group description
    		 Patients were randomized to amitriptyline capsules, administered orally at a dosage of 25 mg amitriptyline per capsule, twice daily for 4 weeks

    Reporting group title
    Placebo arm
    Reporting group description
    		 the placebo were corn starch capsules administered in the same frequency as the experimental drug

    Primary: The difference of forced expiratory volume in one second(FEV1) after 28 days

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    End point title
    		 The difference of forced expiratory volume in one second(FEV1) after 28 days
    End point description
    Lung function was determined in the Intention to treat (ITT) and the per protocol (PP) population as forced expiratory volume in one second (FEV1) after 28 days of amitriptyline or placebo treatment
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    21
    19
    Units: 0-100
        geometric mean (standard deviation)
    0.6 ± 5.7
    -3.8 ± 6.9
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Amitriptyline arm v Placebo arm
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.034
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [1] - This endpoint results were analyzed from the ITT population of the study

    Secondary: The relative fluorescence intensities for ceramide in epithelial cells

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    End point title
    		 The relative fluorescence intensities for ceramide in epithelial cells
    End point description
    The relative fluorescence intensities for ceramide in epithelial cells were scored by a blinded investigator with weak (1), mediate (2), strong (3) and very strong (4).
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Amitriptyline arm Placebo arm
    Number of subjects analysed
    21
    19
    Units: 0-100
    64
    46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The safety of amitriptyline was assessed after each treatment course of 28 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Amitriptyline arm
    Reporting group description
    		 Patients were randomized to amitriptyline capsules, administered orally at a dosage of 25 mg amitriptyline per capsule, twice daily for 4 weeks

    Reporting group title
    Placebo arm
    Reporting group description
    		 the placebo were corn starch capsules administered in the same frequency as the experimental drug

    Serious adverse events
    		 Amitriptyline arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Amitriptyline arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 20 (85.00%)
    14 / 20 (70.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    17 / 20 (85.00%)
    7 / 20 (35.00%)
         occurrences all number
    17
    7
    Common cold
         subjects affected / exposed
    11 / 20 (55.00%)
    6 / 20 (30.00%)
         occurrences all number
    11
    6
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Sleep problems
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Xerostomia
         subjects affected / exposed
    14 / 20 (70.00%)
    3 / 20 (15.00%)
         occurrences all number
    14
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Exacerbation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2009
    Unknown

    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/23572075
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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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