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   43851   clinical trials with a EudraCT protocol, of which   7283   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:
    A single-Centre, open-label, exploratory study of the effect of 20 mg ambroxol hydrochloride on cough reflex sensitivity in patients with acute cough.

    Summary
    EudraCT number
    		 2017-003980-36
    Trial protocol
    		 GB  
    Global end of trial date
    19 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2020
    First version publication date
    19 Jan 2020
    Other versions
    Summary report(s)
    		 final report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IIT15419
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull University Teaching Hospitals NHS Trust
    Sponsor organisation address
    Anlaby road, Hull, United Kingdom, HU3 2JZ
    Public contact
    Caroline Wright, University of Hull, 01482 01482624067, c.e.wright@hull.ac.uk
    Scientific contact
    Caroline Wright, University of Hull, 01482 624067, c.e.wright@hull.ac.uk
    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
    02 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To assess the effect of a single dose of 20 mg ambroxol lozenge on cough reflex sensitivity in patients with acute cough. Cough sensitivity will be measured using an artificially induced cough model, stimulating cough with four different types of challenge agents (citric acid,capsaicin,ATP and distilled water).
    Protection of trial subjects
    none
    Background therapy
    		 None
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    12 Dec 2017
    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
    United Kingdom: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    12
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was an open label, single centre exploratory study in patients with acute cough related to respiratory tract infection. Recruitment took place at Castle Hill Hospital only and patients were recruited through local poster. recruitment started in February 2018 and ended March 20!8.

    Pre-assignment
    Screening details
    		 Males/Females 18–80 years were screened, with acute cough and other symptoms consistent with a common cold or an acute upper respiratory tract infection (URTI) diagnosis. The subjects had onset of symptoms within 72 h of study enrolment; and a Cough Severity VAS ≥ 40 mm at Screening; All subjects coughed at least twice to all cough challenge agents

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding for this study, measurements of cough sensitivity was done at baseline and post 20 mg Ambroxol at 30 and 9o min post dose

    Arms
    Arm title
    		 baseline
    Arm description
    		 -
    Arm type
    		 no intervention

    Investigational medicinal product name
    Ambroxol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Baseline period NO INTERVENTION. Ambroxol administered following baseline measuresadministered by nurse to patient one single 20mg tablet to be sucked until dispersed

    Number of subjects in period 1
    		baseline
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    30 min ambrox
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 30 min post Ambroxol treatment
    Arm description
    		 post 20 mg ambroxol oral lozenge
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ambroxol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered by nurse to patient one single 20mg tablet to be sucked until dispersed

    Number of subjects in period 2
    		30 min post Ambroxol treatment
    Started
    14
    Completed
    14
    Period 3
    Period 3 title
    90 min post ambrox
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 90 min post treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ambroxol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered by nurse to patient one single 20mg tablet to be sucked until dispersed

    Number of subjects in period 3
    		90 min post treatment
    Started
    14
    Completed
    14
    Period 4
    Period 4 title
    recovery
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 recovery
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		recovery
    Started
    14
    Completed
    13
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 14 14
    Age categorical
    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)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    population-adults with acute cough
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ( 12.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -
    Reporting group title
    30 min post Ambroxol treatment
    Reporting group description
    		 post 20 mg ambroxol oral lozenge
    Reporting group title
    90 min post treatment
    Reporting group description
    		 -
    Reporting group title
    recovery
    Reporting group description
    		 -

    Primary: cough reflex sensitivity ATP (C2)

    		 Close Top of page
    End point title
    		 cough reflex sensitivity ATP (C2) [1]
    End point description
    Concentration of ATP causing 2 or more coughs (C2)
    End point type
    Primary
    End point timeframe
    Recorded at baseline, at 30 min post 20 mg ambroxol treatment, 90 minutes post Ambroxol and following recovery of URTI
    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: study was a crossover thus no reporting of statistics as system unable to distinguish this
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment recovery
    Number of subjects analysed
    14
    14
    13
    Units: micromole(s)
        arithmetic mean (standard deviation)
    2.27 ( 2.32 )
    2.52 ( 1.52 )
    3.42 ( 2.67 )
    No statistical analyses for this end point

    Primary: cough reflex sensitivity distilled water (C2)

    		 Close Top of page
    End point title
    		 cough reflex sensitivity distilled water (C2) [2]
    End point description
    measuring % distilled water causing 2 or more coughs
    End point type
    Primary
    End point timeframe
    cough sensiivity to distilled water where two or more coughs C2 measured at baseline, and 30 min,90 min post 20 mg ambroxol and at recovery
    Notes
    [2] - 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: study was a crossover thus no reporting of statistics as system unable to distinguish this
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment recovery
    Number of subjects analysed
    14
    14
    13
    Units: log percent
        arithmetic mean (standard deviation)
    4.39 ( 0.49 )
    4.16 ( 0.45 )
    4.51 ( 0.34 )
    No statistical analyses for this end point

    Primary: cough reflex sensitivity citric acid (C2)

    		 Close Top of page
    End point title
    		 cough reflex sensitivity citric acid (C2) [3]
    End point description
    measuring log concentration of citric acid causing 2 or more coughs
    End point type
    Primary
    End point timeframe
    measuring cough sensitivity to citric acid during upper respiratory tract infection and at 30min, 90 min post 20 mg ambroxol and at recovery from URTI.
    Notes
    [3] - 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: study was a crossover thus no reporting of statistics as system unable to distinguish this
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment recovery
    Number of subjects analysed
    14
    14
    13
    Units: log mM
        arithmetic mean (standard deviation)
    4.83 ( 1.64 )
    4.83 ( 1.2 )
    4.93 ( 1.7 )
    No statistical analyses for this end point

    Primary: cough reflex sensitivity capsaicin (c2)

    		 Close Top of page
    End point title
    		 cough reflex sensitivity capsaicin (c2) [4]
    End point description
    End point type
    Primary
    End point timeframe
    cough reflex sensitivity to capsaicin measured at baseline and at 30 min ,90 min ambroxol and at recovery
    Notes
    [4] - 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: study was a crossover thus no reporting of statistics as system unable to distinguish this
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment recovery
    Number of subjects analysed
    14
    14
    13
    Units: log Micro M
        arithmetic mean (standard deviation)
    2.19 ( 1.79 )
    2.52 ( 1.52 )
    2.80 ( 1.39 )
    No statistical analyses for this end point

    Secondary: cough severity VAS

    		 Close Top of page
    End point title
    		 cough severity VAS
    End point description
    End point type
    Secondary
    End point timeframe
    Cough severity Vas measured at baseline at 30min and 90min post 20mg ambroxol and recovery
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment
    Number of subjects analysed
    14
    14
    Units: mm
        arithmetic mean (standard deviation)
    32.9 ( 1.4 )
    30.2 ( 1.6 )
    No statistical analyses for this end point

    Secondary: urge to cough VAS

    		 Close Top of page
    End point title
    		 urge to cough VAS
    End point description
    End point type
    Secondary
    End point timeframe
    measured at baseline at 30 min and 90 min post 20 mg ambroxol.
    End point values
    		 30 min post Ambroxol treatment 90 min post treatment
    Number of subjects analysed
    14
    14
    Units: mm
        arithmetic mean (standard deviation)
    28.1 ( 2.4 )
    30.4 ( 1.9 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    adverse events were reported from consent up until patient completed the study. reported at baseline post 20 mg ambroxol and at recovery
    Adverse event reporting additional description
    Adverse events were reported from signing of consent until patient completed study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 All patients reports of Adverse events prior to any study related treatment

    Reporting group title
    post 20 mg ambroxol
    Reporting group description
    		 all patients Adverse events reported following administration of 20 mg Ambroxol reported on the day of takin the study treatment.

    Reporting group title
    recovery
    Reporting group description
    		 All patient returning for recovery visit, recording all adverse events since last sen in the unit.

    Serious adverse events
    		 baseline post 20 mg ambroxol recovery
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 baseline post 20 mg ambroxol recovery
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 14 (21.43%)
    3 / 14 (21.43%)
    Injury, poisoning and procedural complications
    Regurgitation
    Additional description: regurgitation in response to cough challenge procedure
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    headache
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatomegaly
    Additional description: enlarged liver found prior to any therapy or procedures
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    1
    Metabolism and nutrition disorders
    Muscle pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1

    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-Sat Apr 20 10:49:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA