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    Clinical Trial Results:
    A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children with a History of Respiratory Syncytial Virus Infection

    Summary
    EudraCT number
    		 2016-002095-26
    Trial protocol
    		 GB   FR   ES   DE   BE   PT   FI   SK   IE   IT  
    Global end of trial date
    13 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2020
    First version publication date
    25 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64041575RSV2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03332459
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen- Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.com
    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
    13 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children who were treated with lumicitabine or placebo in Study 64041575RSV2004 during the follow-up period and within 2 years after the respiratory syncytial virus (RSV) infection.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations were based on the monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2018
    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
    Japan: 7
    Worldwide total number of subjects
    7
    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)
    6
    Children (2-11 years)
    1
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Only subjects previously enrolled in study 64041575RSV2004 (EudraCT ID: 2017-001862-56) were eligible to enroll in this study. Only 7 subjects were enrolled in study 64041575RSV2004 before the study 64041575RSV2004 was prematurely terminated.

    Pre-assignment
    Screening details
    		 Total of 7 subjects were enrolled in this study from study 64041575RSV2004 and completed this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received placebo for the treatment of Respiratory Syncytial Virus (RSV) infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who received placebo in a feeding Phase 2 study (64041575RSV2004) were observed. No study drug was administered in this study.

    Arm title
    		 Lumicitabine 40/20 mg/kg regimen
    Arm description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 40/20 milligrams per kilograms (mg/kg) for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumicitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who received lumicitabine 40/20 mg/kg regimen in a feeding Phase 2 study (64041575RSV2004) were observed. No study drug was administered in this study.

    Arm title
    		 Lumicitabine 60/40 mg/kg regimen
    Arm description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 60/40 mg/kg for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumicitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who received lumicitabine 60/40 mg/kg regimen in a feeding Phase 2 study (64041575RSV2004) were observed. No study drug was administered in this study.

    Number of subjects in period 1
    		Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Started
    3
    1
    3
    Completed
    3
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received placebo for the treatment of Respiratory Syncytial Virus (RSV) infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 40/20 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 40/20 milligrams per kilograms (mg/kg) for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 60/40 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 60/40 mg/kg for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Reporting group values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen Total
    Number of subjects
    		 3 1 3 7
    Title for AgeCategorical
    Units: subjects
        Infants And Toddlers
    		 2 1 3 6
        children
    		 1 0 0 1
    Title for AgeContinuous
    Here '99999' indicates that the data was not estimated due to only single subject was analyzed.
    Units: months
        arithmetic mean (standard deviation)
    		 16 ( 13.08 ) 17 ( 99999 ) 6.3 ( 2.52 ) -
    Title for Gender
    Units: subjects
        Female
    		 0 0 1 1
        Male
    		 3 1 2 6

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received placebo for the treatment of Respiratory Syncytial Virus (RSV) infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 40/20 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 40/20 milligrams per kilograms (mg/kg) for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 60/40 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 60/40 mg/kg for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Primary: Percentage of Subjects With Asthma After Respiratory Syncytial Virus (RSV) Infection

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    End point title
    		 Percentage of Subjects With Asthma After Respiratory Syncytial Virus (RSV) Infection [1]
    End point description
    Percentage of subjects with asthma as diagnosed by a physician was reported. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study.
    End point type
    Primary
    End point timeframe
    Up to 2 Years
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 56.15)
    0 (0 to 79.35)
    0 (0 to 56.15)
    No statistical analyses for this end point

    Primary: Percentage of Wheezing Days in Subjects Within the First 2 Years After RSV Infection

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    End point title
    		 Percentage of Wheezing Days in Subjects Within the First 2 Years After RSV Infection [2]
    End point description
    Percentage of days with wheezing in subjects within the first 2 Years after RSV infection based on information reported by the parent/caregiver was reported. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study. Here '99999' indicates that the standard deviation was not evaluable as no wheezing day was observed in the specified group.
    End point type
    Primary
    End point timeframe
    Up to 2 Years
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Percentage of Wheezing Days
        arithmetic mean (standard deviation)
    0.03 ( 0.058 )
    0.00 ( 99999 )
    2.53 ( 4.388 )
    No statistical analyses for this end point

    Secondary: Percentage of Wheezing Days in Subjects per Month After RSV Infection

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    End point title
    		 Percentage of Wheezing Days in Subjects per Month After RSV Infection
    End point description
    Percentage of wheezing days in subjects per month after RSV infection based on information reported by the parent/caregiver was reported. All Enrolled analysis set included all subjects from the 64041575RSV2004 study who were enrolled in this LTFU study. Here '99999' indicates that the standard deviation was not evaluable as no wheezing day was observed in the specified group.
    End point type
    Secondary
    End point timeframe
    Up to 2 Years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Percentage of Wheezing Days
    arithmetic mean (standard deviation)
        Month 1
    1.00 ( 1.732 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 2
    0.00 ( 0.000 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 3
    0.00 ( 0.000 )
    0.00 ( 99999 )
    5.67 ( 9.815 )
        Month 4
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 5
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 6
    0.00 ( 0.000 )
    0.00 ( 99999 )
    2.00 ( 3.464 )
        Month 7
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 8
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 9
    0.00 ( 0.000 )
    0.00 ( 99999 )
    4.33 ( 7.506 )
        Month 10
    0.00 ( 0.000 )
    0.00 ( 99999 )
    3.33 ( 5.774 )
        Month 11
    0.00 ( 0.000 )
    0.00 ( 99999 )
    5.00 ( 8.660 )
        Month 12
    0.00 ( 0.000 )
    0.00 ( 99999 )
    5.67 ( 9.815 )
        Month 13
    0.00 ( 0.000 )
    0.00 ( 99999 )
    6.33 ( 10.970 )
        Month 14
    0.00 ( 0.000 )
    0.00 ( 99999 )
    4.33 ( 7.506 )
        Month 15
    0.00 ( 0.000 )
    0.00 ( 99999 )
    6.00 ( 10.392 )
        Month 16
    0.00 ( 0.000 )
    0.00 ( 99999 )
    7.67 ( 13.279 )
        Month 17
    0.00 ( 0.000 )
    0.00 ( 99999 )
    4.00 ( 6.928 )
        Month 18
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 19
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 20
    0.00 ( 0.000 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 21
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 22
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 23
    0.00 ( 0.000 )
    0.00 ( 99999 )
    4.00 ( 6.928 )
        Month 24
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
    No statistical analyses for this end point

    Secondary: Number of Wheezing Episodes in Subjects per Month After the RSV Infection

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    End point title
    		 Number of Wheezing Episodes in Subjects per Month After the RSV Infection
    End point description
    Number of wheezing episodes in subjects per month after the RSV infection based on information reported by the parent/caregiver was reported. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study. Here '99999' indicates that the standard deviation was not evaluable as no wheezing episodes were observed in the specified group.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Episodes
    arithmetic mean (standard deviation)
        Month 1
    0.33 ( 0.577 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 2
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 3
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 4
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 5
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 6
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 7
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 8
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 9
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 10
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 11
    0.00 ( 0.000 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 12
    0.00 ( 0.000 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 13
    0.00 ( 0.000 )
    0.00 ( 99999 )
    1.00 ( 1.732 )
        Month 14
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.67 ( 1.155 )
        Month 15
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 16
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 17
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 18
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 19
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 20
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.33 ( 0.577 )
        Month 21
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 22
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
        Month 23
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.67 ( 1.155 )
        Month 24
    0.00 ( 0.000 )
    0.00 ( 99999 )
    0.00 ( 0.000 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Reportable Adverse Events (AEs)

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    End point title
    		 Number of Subjects With Reportable Adverse Events (AEs)
    End point description
    Number of subjects with reportable AEs was reported. The following AEs were considered reportable (within the context of this study): Respiratory illness AEs, including subsequent RSV infections, adverse events considered at least possibly related to study treatment (lumicitabine or placebo, as received in Study 64041575RSV2004), and serious adverse events. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study.
    End point type
    Secondary
    End point timeframe
    Up to 2 Years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    3
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subject and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Respiratory Infections per Subject

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    End point title
    		 Number of Respiratory Infections per Subject
    End point description
    The number of respiratory infections among subjects, based on information reported by the parent/caregiver was reported. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study. Here ‘99999’ indicates that the standard deviation was not estimable as only one subject was analyzed for the respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 2 Years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Infections per Subject
        arithmetic mean (standard deviation)
    10.7 ( 4.62 )
    6.0 ( 99999 )
    19.5 ( 6.36 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Medical Encounters

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    End point title
    		 Number of Subjects with Medical Encounters
    End point description
    Number of subjects with medical encounters (Hospital inpatient department visits, hospital outpatient department visits, medical practitioner office visits) was reported based on information reported by the parent/caregiver. All Enrolled analysis set included all subjects from 64041575RSV2004 study who were enrolled in this LTFU study.
    End point type
    Secondary
    End point timeframe
    Up to 2 Years
    End point values
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
        Hospital Inpatient Department
    0
    0
    1
        Hospital Outpatient Department
    3
    1
    2
        Medical Practitioner Office
    2
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 2 years
    Adverse event reporting additional description
    Reportable AEs (Respiratory illness AEs, including subsequent RSV infections, AEs considered at least possibly related to study treatment [lumicitabine or placebo, as received in Study 64041575RSV2004], and serious adverse events) reported below. All Enrolled analysis set: all subjects from 64041575RSV2004 study enrolled in this LTFU study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received placebo for the treatment of Respiratory Syncytial Virus (RSV) infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 40/20 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 40/20 milligrams per kilograms (mg/kg) for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Reporting group title
    Lumicitabine 60/40 mg/kg regimen
    Reporting group description
    		 Subjects who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received lumicitabine 60/40 mg/kg for the treatment of RSV infection, and who agreed to participate in this follow-up study were assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.

    Serious adverse events
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Exanthema Subitum
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Rotavirus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral Herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Lumicitabine 40/20 mg/kg regimen Lumicitabine 60/40 mg/kg regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    Respiratory, thoracic and mediastinal disorders
    Rhinitis Allergic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    12
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Adenovirus Infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 1 (100.00%)
    1 / 3 (33.33%)
         occurrences all number
    7
    2
    3
    Enterocolitis Viral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Exanthema Subitum
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    15
    Pharyngitis
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 1 (100.00%)
    1 / 3 (33.33%)
         occurrences all number
    8
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    1 / 3 (33.33%)
         occurrences all number
    6
    2
    7

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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.
    Due to the limited number of subjects enrolled in this study (n=7), no meaningful conclusions can be made.
    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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