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    Clinical Trial Results:
    Clinical trial of the efficacy and tolerability of an immunostimulant drug, composed by ribosomal fractions, in socialized paediatric patients in order to prevent recurrent respiratory infections. A randomized, double-blind vs. placebo, multicentre study.

    Summary
    EudraCT number
    		 2008-000487-17
    Trial protocol
    		 IT  
    Global end of trial date
    14 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LF-PF-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Pharma
    Sponsor organisation address
    Via GG Winckelmann, 1, Milano, Italy, 20146
    Public contact
    Dr Sergio Marcassa, Pierre Fabre Pharma, +33 534506169, contact_essais_cliniques@pierre-fabre.com
    Scientific contact
    Dr Sergio Marcassa, Pierre Fabre Pharma, +33 534506169, contact_essais_cliniques@pierre-fabre.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation after 6 months of the effects, vs placebo, of the treatment with Biomunil / Immucytal administrated at the dosage described in the SPC, on the overall duration of the infective episodes.
    Protection of trial subjects
    The study has been carried on in agreement with the last version of the Helsinki Declaration, with the applicable regulatory requirements (European Directive 2001/20/EC, 4 April 2001) with the current Italian Laws (DL. Vo No. 211, 24 Jun 2003 and relate legislation) with the good clinical practice (GCP) norms and with the Guidelines ICH on the Clinic experimentation in Pediatrics.
    Background therapy
    		 No information specified
    Evidence for comparator
    		 Immunostimulant action products (ATC J07AX) represent a category extremely heterogeneous of drugs hardly or at all comparable with each other. For such reason, without any exception, all the controlled studies that use these products also use a placebo group.
    Actual start date of recruitment
    25 Aug 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 164
    Worldwide total number of subjects
    164
    EEA total number of subjects
    164
    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)
    164
    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
    		 164 paediatric patients between 2 and 5 years of age have been recruited in a period between the second half of august and the second half of December 2008 in 4 centres in Italy.

    Pre-assignment
    Screening details
    		 The patients have been screened and randomized into the study the same day (day O).

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immucytal/Biomunil group
    Arm description
    		 84 children were randomised in the experimental group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Immucytal/Biomunil
    Investigational medicinal product code
    J022X
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Flare treatment: One sachet in the morning and fasting for 4 consecutive days per week for three consecutive weeks. Maintenance treatment: One sachet in the morning and fasting for 4 consecutive days at month. The first administration of the first month of maintenance had to be done exactly one month after the first administration of attack therapy. Consequently each first administration of the following months had to be carried out one month after the first month of administration. The contents of the sachet had to be dispersed in half a glass of water.

    Arm title
    		 Placebo group
    Arm description
    		 80 children were randomised in the placebo group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Flare treatment: One sachet in the morning and fasting for 4 consecutive days per week for three consecutive weeks. Maintenance treatment: One sachet in the morning and fasting for 4 consecutive days at month. The first administration of the first month of maintenance had to be done exactly one month after the first administration of attack therapy. Consequently each first administration of the following months had to be carried out one month after the first month of administration. The contents of the sachet had to be dispersed in half a glass of water.

    Number of subjects in period 1
    		Immucytal/Biomunil group Placebo group
    Started
    84
    80
    Completed
    80
    76
    Not completed
    4
    4
         Other
    2
    2
         Lack of collaboration
    1
    2
         Request of the parent/guardian
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Immucytal/Biomunil group
    Reporting group description
    		 84 children were randomised in the experimental group.

    Reporting group title
    Placebo group
    Reporting group description
    		 80 children were randomised in the placebo group.

    Reporting group values
    		 Immucytal/Biomunil group Placebo group Total
    Number of subjects
    		 84 80 164
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 84 80 164
    Age continuous
    Units: years
        median (standard deviation)
    		 3.74 ± 1.03 3.80 ± 1.21 -
    Gender categorical
    Units: Subjects
        Female
    		 33 35 68
        Male
    		 51 45 96
    Children included in a social community
    Units: Subjects
        Yes
    		 82 77 159
        No
    		 2 3 5
    Respiratory system
    Baseline value
    Units: Subjects
        normal
    		 64 61 125
        previous abnormal
    		 19 19 38
        abnormal in progress
    		 1 0 1
    Height
    Units: cm
        median (standard deviation)
    		 100.88 ± 9.49 101.84 ± 10.05 -
    Weight
    Units: kg
        median (standard deviation)
    		 16.87 ± 4.16 17.68 ± 5.05 -
    Recurrent Respiratory Infection in the last year
    Units: number
        median (standard deviation)
    		 6.98 ± 5.58 6.59 ± 4.47 -
    Evaluation of the child's state of well-being (Visual Analog Scale 0-100 mm)
    Units: mm
        median (standard deviation)
    		 68.55 ± 16.34 68.38 ± 18.34 -

    End points

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    End points reporting groups
    Reporting group title
    Immucytal/Biomunil group
    Reporting group description
    		 84 children were randomised in the experimental group.

    Reporting group title
    Placebo group
    Reporting group description
    		 80 children were randomised in the placebo group.

    Subject analysis set title
    J022X ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    81 children who have received at least one dose of study drug and have at least one parameter evaluation main after randomization were included in the J022X ITT population.

    Subject analysis set title
    Placebo ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    77 children who have received at least one dose of study drug and have at least one parameter evaluation main after randomization were included in the Placebo ITT population

    Primary: Overall duration of infectious episodes during 6 months of treatment

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    End point title
    		 Overall duration of infectious episodes during 6 months of treatment
    End point description
    Acute infectious episodes affecting the upper respiratory tract, lower respiratory tract or otitis were subjected to clinical evaluation. An episode was defined as new if they occurred at least 72 hours, in the complete absence of symptoms, from the resolution of the previous episode. During each of the 4 visits, the investigator validated the individual diagnoses of acute infectious episodes based on the review of the diaries kept by the parent (or guardian), of the previous telephone contacts, questions asked directly to the parent (or guardian) and the visit made. The missing values have been replaced considering the last value detected (Last Observation carried forward).
    End point type
    Primary
    End point timeframe
    The duration of infectious episodes was measured during the study treatment period (6 months).
    End point values
    		 J022X ITT population Placebo ITT population
    Number of subjects analysed
    81
    77
    Units: days
        median (standard deviation)
    4.4 ± 3.79
    4.44 ± 3.10
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    J022X ITT population v Placebo ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Duration of infectious episodes during 12 months of observation

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    End point title
    		 Duration of infectious episodes during 12 months of observation
    End point description
    The missing values have been replaced considering the last value detected (Last Observation carried forward).
    End point type
    Secondary
    End point timeframe
    The secondary endpoint was measured during the whole study period (treatment period+ follow-up period).
    End point values
    		 J022X ITT population Placebo ITT population
    Number of subjects analysed
    81
    77
    Units: days
        median (standard deviation)
    4.5 ± 4.02
    4.45 ± 3.18
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    J022X ITT population v Placebo ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event occuring during the study period was recorded in the CRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    J022X Safety population
    Reporting group description
    		 83 patients who received at least one dose of study treatment were included in the Safety population

    Reporting group title
    Placebo Safety population
    Reporting group description
    		 80 patients who received at least one dose of study treatment were included in the Safety population

    Serious adverse events
    		 J022X Safety population Placebo Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 80 (1.25%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Crush injury
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Acute appendicitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 J022X Safety population Placebo Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 83 (56.63%)
    41 / 80 (51.25%)
    Vascular disorders
    Whitlow
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 80 (1.25%)
         occurrences all number
    2
    1
    Immune system disorders
    Urticaria
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 80 (1.25%)
         occurrences all number
    2
    1
    Eye disorders
    Pyrexia
         subjects affected / exposed
    6 / 83 (7.23%)
    2 / 80 (2.50%)
         occurrences all number
    6
    2
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    11 / 83 (13.25%)
    9 / 80 (11.25%)
         occurrences all number
    11
    9
    Enteritis
         subjects affected / exposed
    9 / 83 (10.84%)
    6 / 80 (7.50%)
         occurrences all number
    9
    6
    Vomiting
         subjects affected / exposed
    4 / 83 (4.82%)
    2 / 80 (2.50%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Influenza
         subjects affected / exposed
    8 / 83 (9.64%)
    7 / 80 (8.75%)
         occurrences all number
    8
    7
    Cough
         subjects affected / exposed
    5 / 83 (6.02%)
    2 / 80 (2.50%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Impetigo
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 80 (2.50%)
         occurrences all number
    2
    2
    Scarlet fever
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 80 (2.50%)
         occurrences all number
    2
    2
    Infections and infestations
    Varicella
         subjects affected / exposed
    6 / 83 (7.23%)
    6 / 80 (7.50%)
         occurrences all number
    6
    6
    Conjunctivitis
         subjects affected / exposed
    2 / 83 (2.41%)
    3 / 80 (3.75%)
         occurrences all number
    2
    3

    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
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