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    Clinical Trial Results:
    Ambroxol inhalation for mucus clearance in palliative care patients - a randomized placebo-controlled double-blind pilot study.

    Summary
    EudraCT number
    		 2020-004377-44
    Trial protocol
    		 AT  
    Global end of trial date
    22 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2026
    First version publication date
    27 May 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Ambroxpall
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Eva Katharina Masel, Med. Univ. Wien, Innere Med. I, Abt. f. Palliativmedizin, +43 14040077800, eva.masel@meduniwien.ac.at
    Scientific contact
    Eva Katharina Masel, Med. Univ. Wien, Innere Med. I, Abt. f. Palliativmedizin, +43 14040077800, eva.masel@meduniwien.ac.at
    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
    23 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main study objective is to assess subjective respondent ratings.
    Protection of trial subjects
    To assess the benefit of an ambroxol-inhalation versus placebo in patients with hypersecretion treated in a palliative care unit
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Aug 2021
    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
    Austria: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    5
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruted at the division of palliative medicine of the medical university of vienna

    Pre-assignment
    Screening details
    		 Demographic data, ECOG Performance State, PGIC-Score, Spirometry, Mucus weight, SPO2

    Period 1
    Period 1 title
    Medication (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active phase
    Arm description
    		 The active arm received 10ml ambroxol hydrochloride twice daily for five days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ambroxol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    10ml Ambroxol twice daily for 5 days

    Arm title
    		 Placebo
    Arm description
    		 The placebo arm received 10ml sodium chloride inhalation twice daliy for days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    10ml sodium chloride inhalation twice daily for five days

    Number of subjects in period 1
    		active phase Placebo
    Started
    4
    4
    Completed
    3
    4
    Not completed
    1
    0
         Patient preference
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    active phase
    Reporting group description
    		 The active arm received 10ml ambroxol hydrochloride twice daily for five days

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo arm received 10ml sodium chloride inhalation twice daliy for days

    Reporting group values
    		 active phase Placebo Total
    Number of subjects
    		 4 4 8
    Age categorical
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 3 2 5
        From 65-84 years
    		 1 2 3
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 1 4
        Male
    		 1 3 4
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients in a palliative setting were assessed by the PGIC score (primary endpoint) in regard to the influence of inhalation therapy on their hypersecretion

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    8
    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)
    5
        From 65-84 years
    3
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    active phase
    Reporting group description
    		 The active arm received 10ml ambroxol hydrochloride twice daily for five days

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo arm received 10ml sodium chloride inhalation twice daliy for days

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients in a palliative setting were assessed by the PGIC score (primary endpoint) in regard to the influence of inhalation therapy on their hypersecretion

    Primary: PGIC score

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    End point title
    		 PGIC score [1]
    End point description
    End point type
    Primary
    End point timeframe
    First score day5 second score day 12
    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: PGIC scores could not be collected from enough patients to perform a statistical analysis
    End point values
    		 active phase Placebo
    Number of subjects analysed
    4
    4
    Units: number
    3
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Entire Study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    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: There was no adverse events in this study.

    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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