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   43870   clinical trials with a EudraCT protocol, of which   7289   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:
    Effectiveness of antitussive, anticholinergic and honey therapy versus usual practice in adults with uncomplicated acute bronchitis [AB4T study]

    Summary
    EudraCT number
    		 2018-002563-25
    Trial protocol
    		 ES  
    Global end of trial date
    04 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2022
    First version publication date
    29 Dec 2022
    Other versions
    Summary report(s)
    		 Effectiveness of antitussives, anticholinergics, and honey versus usual care in adults with uncomplicated acute bronchitis: a multiarm randomized clinical trial

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IJG-AB4T-2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IDIAP Jordi Gol
    Sponsor organisation address
    Gran Via de les Corts Catalanes, 587, Barcelona, Spain, 08007
    Public contact
    Unitat Estudis Medicament, IDIAP Jordi Gol, 34 934824644, agarcia@idiapjgol.org
    Scientific contact
    Unitat Estudis Medicament, IDIAP Jordi Gol, 34 934824644, agarcia@idiapjgol.org
    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 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the clinical effectiveness of adding 3 symptomatic treatments (dextromethorphan, ipratropium bromide or honey) to normal practice in the reduction of days with moderate-severe cough compared with usual practice
    Protection of trial subjects
    Not applicable. Low risk intervention trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2019
    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
    Spain: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    146
    From 65 to 84 years
    45
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients aged 18 years or older, who come to the primary care physician with cough of up to 3 weeks of evolution compatible with an acute bronchitis and who agree to participate in the clinical trial. Patients with suspected mild Covid-19 infection who present with cough as the predominant symptom, with symptoms compatible with acute bronchitis, wi

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 usual care+dextromethorphan
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEXTROMETHORPHAN HYDROBROMIDE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg t.i.d.

    Arm title
    		 usual care+ipratropium bromide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPRATROPIUM BROMIDE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    20 μg, 2 puffs t.i.d

    Arm title
    		 usual care+honey
    Arm description
    		 -
    Arm type
    		 Natural treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 usual care
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		usual care+dextromethorphan usual care+ipratropium bromide usual care+honey usual care
    Started
    45
    53
    49
    47
    Completed
    22
    25
    26
    20
    Not completed
    23
    28
    23
    27
         Consent withdrawn by subject
    -
    -
    1
    -
         Diary not fulfilled
    11
    18
    14
    17
         Adverse event, non-fatal
    1
    2
    -
    -
         Lost to follow-up
    9
    5
    8
    10
         Lack of efficacy
    1
    2
    -
    -
         Protocol deviation
    1
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    usual care+dextromethorphan
    Reporting group description
    		 -

    Reporting group title
    usual care+ipratropium bromide
    Reporting group description
    		 -

    Reporting group title
    usual care+honey
    Reporting group description
    		 -

    Reporting group title
    usual care
    Reporting group description
    		 -

    Reporting group values
    		 usual care+dextromethorphan usual care+ipratropium bromide usual care+honey usual care Total
    Number of subjects
    		 45 53 49 47 194
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.0 ( 17.6 ) 56.1 ( 14.3 ) 50.5 ( 15.4 ) 20.5 ( 17.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 37 32 30 130
        Male
    		 14 16 17 17 64

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    usual care+dextromethorphan
    Reporting group description
    		 -

    Reporting group title
    usual care+ipratropium bromide
    Reporting group description
    		 -

    Reporting group title
    usual care+honey
    Reporting group description
    		 -

    Reporting group title
    usual care
    Reporting group description
    		 -

    Primary: Day reduction in the duration of moderate-severe cough

    		 Close Top of page
    End point title
    		 Day reduction in the duration of moderate-severe cough
    End point description
    End point type
    Primary
    End point timeframe
    Daily evaluation by the patient's diary, which is collected in the face-to-face visit on day 15 and, if necessary, on the 29th day
    End point values
    		 usual care+dextromethorphan usual care+ipratropium bromide usual care+honey usual care
    Number of subjects analysed
    34
    35
    35
    30
    Units: 1
    32
    31
    32
    28
    Statistical analysis title
    		 Kaplan–Meier survival analysis
    Statistical analysis description
    Kaplan–Meier survival analysis of days with moderate-to-severe cough, that is, time (days) from baseline visit until patient last scored ≥3 in either daytime or nocturnal cough in the symptom diary.
    Comparison groups
    usual care+dextromethorphan v usual care+ipratropium bromide v usual care+honey v usual care
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 2-3, Day 15 and Day 29
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    usual care+dextromethorphan
    Reporting group description
    		 -

    Reporting group title
    usual care+ipratropium bromide
    Reporting group description
    		 -

    Reporting group title
    usual care+honey
    Reporting group description
    		 -

    Reporting group title
    usual care
    Reporting group description
    		 -

    Serious adverse events
    		 usual care+dextromethorphan usual care+ipratropium bromide usual care+honey usual care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 usual care+dextromethorphan usual care+ipratropium bromide usual care+honey usual care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 53 (3.77%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    Cardiac disorders
    palpitations
    Additional description: slight increasing of cardiac frequency
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0
    General disorders and administration site conditions
    headache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 53 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gastrointestinal disorders
    diarrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 53 (1.89%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2020
    Adaptation of the protocol to the current pandemic situation caused by SARS-CoV-2

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Mar 2020
    The outbreak of the COVID-19 pandemic in March 2020. COVID-19 infection, clearly interfered with the normal development of the trial.
    18 Dec 2020

    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/36239199
    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-Wed May 01 05:08:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA