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    Clinical Trial Results:
    A single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis

    Summary
    EudraCT number
    		 2019-000580-24
    Trial protocol
    		 GB  
    Global end of trial date
    09 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions
    Summary report(s)
    		 Study summary

    Trial information

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    Trial identification
    Sponsor protocol code
    R2347
    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
    Castle Hill Hospital, Castle Road, Cottingham, Kingston-upon-Hull, United Kingdom, HU16 5JQ
    Public contact
    Dr Simon Hart, Hull York Medical School/ University of Hull, +44 01482624067, s.hart@hull.ac.uk
    Scientific contact
    Dr Simon Hart, Hull York Medical School/ University of Hull, +44 01482624067, s.hart@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
    09 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Assess the effect of azithromycin on cough measured using automated cough counting
    Protection of trial subjects
    The investigator or designee will question subjects about AEs and intercurrent illnesses at Baseline and at all subsequent visits since their last visit. The pertinent information will be recorded on the CRF. Safety will be assessed through monitoring of adverse events/serious adverse events of special interest, physical examinations, vital signs, and 12-lead ECGs. Safety assessment frequency is shown in the Schedule of Assessments and Procedures Robust consent process in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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
    United Kingdom: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    0
    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)
    18
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Once informed consent has been obtained, the following assessments will be performed and recorded: • Medical history and demographics • Vital signs (sitting systolic and diastolic blood pressure, pulse, respiration rate, body temperature) • Weight and height • Physical examination • ECG (12 lead)Concomitant medication • Cough VAS • LCQ •

    Period 1
    Period 1 title
    Visit 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Test
    Arm description
    		 The Screening/baseline visit will ensure that each subject meets all the specified inclusion criteria and none of the exclusion criteria. Once consented, the Hull Automated Cough Counter will be given to the patient with verbal and written instructions. The initial supply of study drug (azithromycin 250mg once daily) will be issued, with written instructions to take the first dose on the day after completing the cough counting. The subject will return the cough counter for analysis at their convenience.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin 250mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available 250 mg azithromycin, administered as a tablet oral azithromycin 250 mg once daily for 3 months

    Number of subjects in period 1
    		Test
    Started
    21
    Completed
    21
    Period 2
    Period 2 title
    Visit 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Test
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin 250mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available 250 mg azithromycin, administered as a tablet oral azithromycin 250 mg once daily for 3 months

    Number of subjects in period 2 [1]
    		Test
    Started
    20
    Completed
    20
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant left the trial due at 1 month due to work commitments.
    Period 3
    Period 3 title
    Visit 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Test
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin 250mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available 250 mg azithromycin, administered as a tablet oral azithromycin 250 mg once daily for 3 months

    Number of subjects in period 3
    		Test
    Started
    20
    Completed
    20

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 The Screening/baseline visit will ensure that each subject meets all the specified inclusion criteria and none of the exclusion criteria. Once consented, the Hull Automated Cough Counter will be given to the patient with verbal and written instructions. The initial supply of study drug (azithromycin 250mg once daily) will be issued, with written instructions to take the first dose on the day after completing the cough counting. The subject will return the cough counter for analysis at their convenience.
    Reporting group title
    Test
    Reporting group description
    		 -
    Reporting group title
    Test
    Reporting group description
    		 -

    Primary: 24hr Cough count

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    End point title
    		 24hr Cough count
    End point description
    End point type
    Primary
    End point timeframe
    24hr
    End point values
    		 Test Test Test
    Number of subjects analysed
    21
    20
    20
    Units: Coughs per hour
        number (not applicable)
    14.63
    16.68
    18.23
    Statistical analysis title
    		 p-value
    Comparison groups
    Test v Test v Test
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator or designee will question subjects about AEs and intercurrent illnesses at Baseline and at all subsequent visits since their last visit. The pertinent information will be recorded on the CRF. Safety will be assessed through monitoring
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Common cold
    Reporting group description
    		 -

    Reporting group title
    Gastrointestinal symptoms
    Reporting group description
    		 -

    Reporting group title
    Transient worsening cough
    Reporting group description
    		 -

    Serious adverse events
    		 Common cold Gastrointestinal symptoms Transient worsening cough
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (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
    		 Common cold Gastrointestinal symptoms Transient worsening cough
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 21 (28.57%)
    2 / 21 (9.52%)
    2 / 21 (9.52%)
    Gastrointestinal disorders
    Transient gastrointestinal symptoms
    Additional description: Stomach cramps, slight reduction in appetite.
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Common cold
    Additional description: 6 patients suffered with a common cold (trial took place over winter).
         subjects affected / exposed
    6 / 21 (28.57%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    6
    0
    0
    Transient worsening cough
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    2

    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? Yes
    Date
    Interruption
    Restart date
    29 May 2020
    At this time our focus changed to COVID-19 research.
    -

    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.

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