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    Clinical Trial Results:
    A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION

    Summary
    EudraCT number
    		 2012-003331-32
    Trial protocol
    		 BE  
    Global end of trial date
    07 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions
    Summary report(s)
    		 Final results AZI0003

    Trial information

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    Trial identification
    Sponsor protocol code
    AZI003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01915082
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KU Leuven
    Sponsor organisation address
    49 Herestraat , Leuven, Belgium, B-3000
    Public contact
    Dr. Robin Vos Dr. Bart Vanaudenaerde, Lab of Pneumology, KULeuven, +32 1633 01 94, bart.vanaudenaerde@med.kuleuven.be
    Scientific contact
    Dr. Robin Vos Dr. Bart Vanaudenaerde, Lab of Pneumology, KULeuven, +32 1633 01 94, robin.vos@uzleuven.be
    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
    08 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Improvement in mean pulmonary function (FEV1; %pred) during the first 3 months after lung transplantation
    Protection of trial subjects
    Routine post-transplant follow-up, immunosuppressive regimen and infectious prophylaxis was given to all patients according to standardized protocols, independent of study drug. Adverse events were monitored by the treating LTx clinician (blinded for study-drug) and were defined as hearing loss, cardiac arrhythmias (e.g. torsade de pointes), serious allergic reactions including skin reactions (rash, urticaria or Stevens-Johnson syndrome), angioneurotic edema and anaphylaxis and neurologic disorders (convulsions).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2013
    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
    Belgium: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    68
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 120 patients who underwent double LTx between October 2013 and October 2015 were screened for inclusion.

    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, Monitor, Data analyst, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Azithromycin
    Arm description
    		 Study drug was added to standard of care and was administered once immediately before LTx (1000 mg of azithromycin or placebo) and every other day from day 1 until day 31 after LTx (250 mg of azithromycin or placebo).
    Arm type
    		 Experimental

    Investigational medicinal product name
    azithromycin
    Investigational medicinal product code
    Other name
    Zitromax® oral suspension 200 mg/ 5 mL
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Zitromax® oral suspension 200 mg/ 5 mL

    Arm title
    		 PLacebo
    Arm description
    		 Ora-plus (97% purified water, <1% Sodium phosphate monobasic, <1% Sodium carboxymethylcellulose, <1% Microcrystalline cellulose, <1% Xanthan gum, <1% Carrageenan)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ora-plus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Ora-plus (97% purified water, <1% Sodium phosphate monobasic, <1% Sodium carboxymethylcellulose, <1% Microcrystalline cellulose, <1% Xanthan gum, <1% Carrageenan) suspension

    Number of subjects in period 1
    		Azithromycin PLacebo
    Started
    34
    34
    Completed
    34
    34

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 Study drug was added to standard of care and was administered once immediately before LTx (1000 mg of azithromycin or placebo) and every other day from day 1 until day 31 after LTx (250 mg of azithromycin or placebo).

    Reporting group title
    PLacebo
    Reporting group description
    		 Ora-plus (97% purified water, <1% Sodium phosphate monobasic, <1% Sodium carboxymethylcellulose, <1% Microcrystalline cellulose, <1% Xanthan gum, <1% Carrageenan)

    Primary: Pulmonary function

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    End point title
    		 Pulmonary function
    End point description
    End point type
    Primary
    End point timeframe
    3 months after transplant
    End point values
    		 Azithromycin PLacebo
    Number of subjects analysed
    34
    34
    Units: percentage predicted
        median (inter-quartile range (Q1-Q3))
    5 (1 to 10)
    6 (2 to 11)
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Patient proportions were compared using the chi-squaretest. Continuous data are presented as mean and standard error ofthe mean when normally distributed, or as a median with inter-quartile range when non‒normally distributed. Group means werecompared using unpaired, two-tailedt-test or Mann−WhitneyU-test for normally or non‒normally distributed variables, respectively. GraphPad Prism 6.0 software (GraphPad) was used for statistical analysis. p-values are two-sided, with p<0.05 significant.
    Comparison groups
    Azithromycin v PLacebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At every patient contact during the study period, minimum at least every 4 months
    Adverse event reporting additional description
    None of the previously defined adverse events were reported in either the study or placebo group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    azithromycin
    Reporting group description
    		 -

    Serious adverse events
    		 placebo azithromycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    6
    4
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 placebo azithromycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    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: No predefined adverse events were recorded

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30686699
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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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