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    Clinical Trial Results:
    Efficacy and tolerability clinical trial of Lantigen B (A bacterial lysate having immunostimulating activity) in the prophylaxis of respiratory infections, with special reference to patients with allergy to perennial inhalants. Double-blind multicenter, randomized study vs. placebo.

    Summary
    EudraCT number
    		 2011-003239-76
    Trial protocol
    		 IT  
    Global end of trial date
    28 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2020
    First version publication date
    21 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LAN-BR-11-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bruschettini S.r.l.
    Sponsor organisation address
    Via Isonzo, Genoa, Italy, 16127
    Public contact
    Clinical Research Department, Medi Service SRL, 0039 039-6057074, medi@mediservice.it
    Scientific contact
    Clinical Research Department, Medi Service SRL, 0039 039-6057074, medi@mediservice.it
    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
    10 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy of LANTIGEN B vs. placebo, in reducing, during a 8-month period, the number of infective episodes of the respiratory tract .
    Protection of trial subjects
    During the study follow-up, to minimise the patients pain/distress, it was permitted to take the following concomitant medications: antibiotics, decongestant, mucolytics.
    Background therapy
    		 During the two weeks preceding the randomization the following drugs were not allowed: Immune-stimulants, gamma-globulines, etc. of the ATC group J06 and J07AX; Anti-neoplastic drugs of the ATC group L01; Cytokines, interleukins, interferon, immune-suppressants of the ATC group L03 and L04. After the randomization and during the study (including the follow-up period) the following drugs were not permitted: Immune-stimulants of the ATC group J07AX; Anti-neoplastic drugs of the ATC group L01; Cytokines, interleukins, interferon, immune-suppressants of the ATC group L03 and L04; Systemic steroids (if used for more than 2 weeks); Any drug product or dietary supplement containing zinc (if used for more than one week); Any other product with immune-stimulant features.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2012
    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
    Italy: 160
    Worldwide total number of subjects
    160
    EEA total number of subjects
    160
    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)
    151
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 160 subjects were enrolled in 12 Italian Clinical Centres in the period September 2012 - January 2013.

    Pre-assignment
    Screening details
    		 Run-in and/or screening periods were not planned in the study design. Randomization visit (Visit 1) was considered as baseline period. Wash-out period: during the two weeks preceding the randomization the following drugs were not allowed: ATC groups J06, J07AX, L01, L03 and L04.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lantigen B
    Arm description
    		 Lantigen B is a suspension of bacterial antigens obtained from Streptococcus pneumoniae type 3, Streptococcus pyogenes Group A, Branhamella catarrhalis, Staphylococcus aureus, Hemophilus influenzae type b and Klebsiella pneumoniae.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lantigen B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Administration: 15 oral drops twice daily (morning and evening) for 4 weeks, followed by 2 weeks off + 4 weeks of treatment + 6 weeks off, for a total of 16 weeks in two cycles.

    Arm title
    		 placebo
    Arm description
    		 placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Administration: 15 oral drops twice daily (morning and evening) for 4 weeks, followed by 2 weeks off + 4 weeks of treatment + 6 weeks off, for a total of 16 weeks in two cycles

    Number of subjects in period 1
    		Lantigen B placebo
    Started
    79
    81
    Completed
    62
    58
    Not completed
    17
    23
         Familiar reasons
    -
    1
         Consent withdrawn by subject
    10
    13
         Adverse event, non-fatal
    1
    2
         Patient not contactable
    -
    1
         Lost to follow-up
    1
    4
         Protocol deviation
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lantigen B
    Reporting group description
    		 Lantigen B is a suspension of bacterial antigens obtained from Streptococcus pneumoniae type 3, Streptococcus pyogenes Group A, Branhamella catarrhalis, Staphylococcus aureus, Hemophilus influenzae type b and Klebsiella pneumoniae.

    Reporting group title
    placebo
    Reporting group description
    		 placebo

    Reporting group values
    		 Lantigen B placebo Total
    Number of subjects
    		 79 81 160
    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)
    		 42.38 ( 13.937 ) 42.43 ( 15.146 ) -
    Gender categorical
    Units: Subjects
        Female
    		 54 58 112
        Male
    		 25 23 48
    Number of previous infectious episodes
    Number of infectious episodes of the respiratory tract in the previous year.
    Units: number
        arithmetic mean (standard deviation)
    		 3.67 ( 1.615 ) 3.84 ( 1.337 ) -
    Number of previous allergic episodes
    Number of allergic episodes in the previous year.
    Units: number
        arithmetic mean (standard deviation)
    		 1.57 ( 4.376 ) 1.25 ( 2.467 ) -

    End points

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    End points reporting groups
    Reporting group title
    Lantigen B
    Reporting group description
    		 Lantigen B is a suspension of bacterial antigens obtained from Streptococcus pneumoniae type 3, Streptococcus pyogenes Group A, Branhamella catarrhalis, Staphylococcus aureus, Hemophilus influenzae type b and Klebsiella pneumoniae.

    Reporting group title
    placebo
    Reporting group description
    		 placebo

    Primary: Number of respiratory infectious episode

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    End point title
    		 Number of respiratory infectious episode
    End point description
    An infectious episode was defined as “new” if at least 72 hours had passed, in the complete absence of symptoms, from the resolution of the previous episode.
    End point type
    Primary
    End point timeframe
    Respiratory infectious episodes during the 8 months of follow-up
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [1]
    58 [2]
    Units: number
        arithmetic mean (standard deviation)
    0.86 ( 1.238 )
    1.43 ( 1.613 )
    Notes
    [1] - ITT Population
    [2] - ITT population
    Statistical analysis title
    		 Independent-Samples t-test / GLM analysis
    Statistical analysis description
    Independent-Samples t-test. ANCOVA Analysis, adjusting for the number of previous infectious episodes and gender.
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.036 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Cox proportional hazard
    Confidence interval
    Notes
    [3] - ITT Population: Primary end-point analysis
    [4] - ANCOVA, applied by adjusting for the number of previous infectious episodes and gender, confirmed this finding (p=0.019). Wilcoxon Rank-sum Test p-value = 0.080.

    Secondary: Number of days with respiratory infectious episodes

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    End point title
    		 Number of days with respiratory infectious episodes
    End point description
    Number of days with respiratory infectious episodes during 8 months
    End point type
    Secondary
    End point timeframe
    8 months follow-up study
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [5]
    58 [6]
    Units: number
        arithmetic mean (standard deviation)
    5.83 ( 9.839 )
    10.14 ( 15.575 )
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Independent-Samples t-test / GLM analysis
    Statistical analysis description
    Independent-Samples t-test. ANCOVA Analysis, adjusting for the number of previous infectious episodes and gender.
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.076 [8]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [7] - Secondary end-point analysis.
    [8] - The ANCOVA, applied by adjusting for the number of previous infectious episodes and gender, confirmed this finding (p=0.102).

    Secondary: Number of days with episodes of allergy

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    End point title
    		 Number of days with episodes of allergy
    End point description
    Number of days with episodes of allergy during the 8 months of follow-up.
    End point type
    Secondary
    End point timeframe
    During the 8 months of follow-up study.
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [9]
    58 [10]
    Units: Number
        arithmetic mean (standard deviation)
    12.69 ( 31.701 )
    2.84 ( 7.991 )
    Notes
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Independent-Samples t-test / GLM analysis
    Statistical analysis description
    Independent-Samples t-test. ANCOVA Analysis, adjusting for the number of previous infectious episodes and gender.
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.024 [12]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [11] - Secondary end-point analysis
    [12] - The ANCOVA, applied by adjusting for the number of previous infectious episodes and gender, not confirmed this finding (p=0.056).

    Secondary: Number of days lost at work or school

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    End point title
    		 Number of days lost at work or school
    End point description
    End point type
    Secondary
    End point timeframe
    Period: 8 months follow-up study.
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [13]
    57 [14]
    Units: number
        arithmetic mean (standard deviation)
    0.75 ( 2.570 )
    0.79 ( 2.433 )
    Notes
    [13] - ITT Population
    [14] - ITT Population (missing value for 1 subject)
    Statistical analysis title
    		 Independent-Samples t-test
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.925
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [15] - Secondary end-point analysis

    Secondary: General well-being

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    End point title
    		 General well-being
    End point description
    Evaluated by the subjects using a VAS scale (from 0 to 10).
    End point type
    Secondary
    End point timeframe
    End of Study: after 2 treatment cycles.
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [16]
    56 [17]
    Units: number
        arithmetic mean (standard deviation)
    7.28 ( 1.708 )
    7.47 ( 1.283 )
    Notes
    [16] - ITT population
    [17] - ITT population: missing values for 2 subjects.
    Statistical analysis title
    		 Independent-Samples t-test
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 = 0.496
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [18] - Secondary end-point analysis

    Secondary: Global efficacy

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    End point title
    		 Global efficacy
    End point description
    The global efficacy was evaluated by the Investigator using a 5-item scale.
    End point type
    Secondary
    End point timeframe
    End of Study Visit
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    58 [19]
    57 [20]
    Units: number
        Worsened
    2
    3
        Unchanged
    25
    22
        Improved
    31
    32
    Notes
    [19] - ITT Population: missing value for 1 subject
    [20] - ITT Population: missing value for 1 subject
    Statistical analysis title
    		 Chi Square test
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.686
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [21] - Secondary end-point analysis

    Secondary: Global safety

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    End point title
    		 Global safety
    End point description
    The global safety was evaluated by the Investigator using a 5-item scale.
    End point type
    Secondary
    End point timeframe
    End of Study Visit
    End point values
    		 Lantigen B placebo
    Number of subjects analysed
    59 [22]
    57 [23]
    Units: number
        Excellent
    24
    21
        Good
    30
    29
        Fair
    5
    7
    Notes
    [22] - ITT Population
    [23] - ITT Population: missing value for 1 subject
    Statistical analysis title
    		 Chi Square test
    Comparison groups
    Lantigen B v placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.735
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events reported during the study (from baseline to the last visit) were taken into account.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Lantigen B
    Reporting group description
    		 Lantigen B is a suspension of bacterial antigens obtained from Streptococcus pneumoniae type 3, Streptococcus pyogenes Group A, Branhamella catarrhalis, Staphylococcus aureus, Hemophilus influenzae type b and Klebsiella pneumoniae.

    Reporting group title
    placebo
    Reporting group description
    		 placebo

    Serious adverse events
    		 Lantigen B placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 76 (2.63%)
    1 / 74 (1.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Cancer
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Nasopharynx biopsy
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip prosthesis insertion
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 Lantigen B placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 76 (13.16%)
    15 / 74 (20.27%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Cryosurgery of turbinates
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    2
    Social circumstances
    Premenopause
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Duodenogastric reflux
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 74 (2.70%)
         occurrences all number
    2
    3
    Chest pain
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    skin rush
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Genitourinary tract infection
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 74 (1.35%)
         occurrences all number
    3
    1
    Arthralgia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Pain ankle
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Lipoma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Candida infection
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    Herpes labialis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1

    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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