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    Clinical Trial Results:
    Efficacy and tolerability clinical trial of an immunostimulant made from inactivated bacteria (BUCCALIN) in the prophylaxis of infection of the airways (rhinotracheobronchitis, colds). Double-blind multicenter, randomized study vs. placebo.

    Summary
    EudraCT number
    		 2011-005187-25
    Trial protocol
    		 IT  
    Global end of trial date
    05 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jul 2020
    First version publication date
    18 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BUC-SI-11-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorio Farmaceutico S.I.T. Srl
    Sponsor organisation address
    Via Cavour 70, Mede (PV), Italy, 27035
    Public contact
    Ricerca Clinica, Medi Service SRL, 0039 039 6057074, medi@mediservice.it
    Scientific contact
    Ricerca Clinica, 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
    16 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison, vs placebo, during 6 months of the infective episodes of the respiratory tract (number of days of illness) from the day of the first dose. Number of illness days recorded by the patient on a special diary.
    Protection of trial subjects
    During the study period, to minimise the patients pain/distress, it was permitted to take the following concomitant medications: antibiotics, anti-inflammatory, bronchodilators, decongestant, mucolytics. The subject's wellbeing was evaluated at month 4 and month 6.
    Background therapy
    		 During the two weeks preceding the randomization the following drugs were not allowed: Immunestimulants, 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
    		 To minimise the patients pain/distress, it was permitted to take the following concomitant medications: antibiotics, anti-inflammatory, bronchodilators, decongestant, mucolytics.
    Actual start date of recruitment
    01 Feb 2012
    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: 178
    Worldwide total number of subjects
    178
    EEA total number of subjects
    178
    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)
    176
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 187 subjects were enrolled in 10 Italian Clinical Centres in the period September 2012 - September 2013. The Full Analysis Set (FAS) population consisted of 178 subjects (88 assigned to placebo and 90 to Buccalin).

    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 visit.

    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, Monitor
    Blinding implementation details
    This study had a double blind design. A computer generated randomisation list in blocks of 4, to balance the random allocation to each treatment, was managed by CRO. A duly closed and sealed copy of randomisation list was kept by the Sponsor. Each Investigator received a set of sealed envelopes, one for each subject assigned to his/her centre. Each envelope contained the identity of subject’s treatment, formed by a three-digit number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Buccalin
    Arm description
    		 Buccalin is constituted by mixture of: Streptococcus pneumonia I, II, III: 1*10^9 inactivated bacterial bodies Streptococcus haemolyticus (agalactiae): 1*10^9 inactivated bacterial bodies Staphylococcus aureus: 1*10^9 inactivated bacterial bodies Hemophilus influenza: 1.5*10^9 inactivated bacterial bodies
    Arm type
    		 Experimental

    Investigational medicinal product name
    Buccalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administration: first three days of each of the four treatment cycles according to the following scheme: one tablet on day 1, two tablets on day 2, four tablets on day 3.

    Arm title
    		 placebo
    Arm description
    		 The placebo consisted of gastroresistant tablets containing only excipients (lactose, micro.-crystalline cellulose).
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administration: first three days of each of the four treatment cycles according to the following scheme: one tablet on day 1, two tablets on day 2, four tablets on day 3.

    Number of subjects in period 1
    		Buccalin placebo
    Started
    90
    88
    Completed
    84
    86
    Not completed
    6
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    4
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Buccalin
    Reporting group description
    		 Buccalin is constituted by mixture of: Streptococcus pneumonia I, II, III: 1*10^9 inactivated bacterial bodies Streptococcus haemolyticus (agalactiae): 1*10^9 inactivated bacterial bodies Staphylococcus aureus: 1*10^9 inactivated bacterial bodies Hemophilus influenza: 1.5*10^9 inactivated bacterial bodies

    Reporting group title
    placebo
    Reporting group description
    		 The placebo consisted of gastroresistant tablets containing only excipients (lactose, micro.-crystalline cellulose).

    Reporting group values
    		 Buccalin placebo Total
    Number of subjects
    		 90 88 178
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 90 86 176
        From 65-84 years
    		 0 2 2
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.4 ( 11.6 ) 48.5 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 49 50 99
        Male
    		 41 38 79
    Previous (1 year) infectious episodes of airways
    Units: Subjects
        2 infectious episodes
    		 11 10 21
        3 infectious episodes
    		 22 28 50
        4 infectious episodes
    		 20 24 44
        5 infectious episodes
    		 18 12 30
        6 infectious episodes
    		 19 14 33
    Smoking history
    Units: Subjects
        Current smoker
    		 12 15 27
        Passive smoker
    		 16 10 26
        No smoker
    		 62 63 125

    End points

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    End points reporting groups
    Reporting group title
    Buccalin
    Reporting group description
    		 Buccalin is constituted by mixture of: Streptococcus pneumonia I, II, III: 1*10^9 inactivated bacterial bodies Streptococcus haemolyticus (agalactiae): 1*10^9 inactivated bacterial bodies Staphylococcus aureus: 1*10^9 inactivated bacterial bodies Hemophilus influenza: 1.5*10^9 inactivated bacterial bodies

    Reporting group title
    placebo
    Reporting group description
    		 The placebo consisted of gastroresistant tablets containing only excipients (lactose, micro.-crystalline cellulose).

    Primary: Number of days with infectious disease

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    End point title
    		 Number of days with infectious disease
    End point description
    End point type
    Primary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [1]
    88 [2]
    Units: number
        arithmetic mean (standard deviation)
    6.6 ( 8.0 )
    7.5 ( 10.6 )
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    Statistical analysis title
    		 Primary efficacy analysis
    Statistical analysis description
    The primary study objective was to the comparison between the test drug (Buccalin) and placebo of the number of days with respiratory infections in the follow-up period of 6 months, starting from the beginning of treatment, as recorded in the subject’s diary.
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Marginal Means difference
    Point estimate
    -1.724
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.293
         upper limit
    		 -0.154
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.795
    Notes
    [3] - Analysis of Covariace (ANCOVA) Dependent variable: number of days with respiratory infections in the follow-up period of 6 months Factor: treatment group Covariates: number of previous infections and total number of infectious episodes

    Secondary: Total number of infectious episodes

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    End point title
    		 Total number of infectious episodes
    End point description
    Number of respiratory infectious episodes at 6 months
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [4]
    88 [5]
    Units: number
        arithmetic mean (standard deviation)
    1.1 ( 1.2 )
    0.9 ( 1.2 )
    Notes
    [4] - Full Analysis Set
    [5] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Statistical analysis description
    Number of respiratory infectious episodes at 6 months.
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.671 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Marginal Means difference
    Point estimate
    0.077
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.279
         upper limit
    		 0.433
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.181
    Notes
    [6] - Analysis of Covariance (ANCOVA): Dependent variable: total number of infectious episodes Factor: treatment group Covariate: number of previous infectious episodes

    Secondary: Severity of infectious episodes (month 0-4)

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    End point title
    		 Severity of infectious episodes (month 0-4)
    End point description
    End point type
    Secondary
    End point timeframe
    Month 0-4
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90
    88
    Units: number
        mild
    47
    38
        moderate
    43
    38
        severe
    1
    1
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    placebo v Buccalin
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.953
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Severity of infectious episodes (month 4-6)

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    End point title
    		 Severity of infectious episodes (month 4-6)
    End point description
    End point type
    Secondary
    End point timeframe
    Month 4-6
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [7]
    88 [8]
    Units: number
        mild
    3
    6
        moderate
    3
    3
        severe
    1
    1
    Notes
    [7] - Full Analysis Set
    [8] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.784
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Global efficacy, evaluated by the Investigator

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    End point title
    		 Global efficacy, evaluated by the Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [9]
    88 [10]
    Units: number
        Worsened
    0
    1
        Unchanged
    10
    7
        Improved
    47
    53
        Markedly improved
    27
    25
    Notes
    [9] - Full Analysis Set For 6 subjects the value is missing
    [10] - Full Analysis Set For 2 subjects the value is missing
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.584
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Global safety, evaluated by the Patient

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    End point title
    		 Global safety, evaluated by the Patient
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [11]
    88 [12]
    Units: number
        Excellent
    44
    47
        Good
    39
    37
        Fair
    1
    2
    Notes
    [11] - Full Analysis Set For 6 subjects the value is missing
    [12] - Full Analysis Set For 2 subjecst the value is missing
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.794
    Method
    		 Chi-squared
    Confidence interval

    Secondary: General well-being, evaluated by the Patient

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    End point title
    		 General well-being, evaluated by the Patient
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [13]
    88 [14]
    Units: number
        arithmetic mean (standard deviation)
    7.7 ( 1.39 )
    7.8 ( 1.33 )
    Notes
    [13] - Full Analysis Set
    [14] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.724 [15]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [15] - Independent samples t-test p-value

    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
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [16]
    88 [17]
    Units: number
        arithmetic mean (standard deviation)
    1.3 ( 3.45 )
    1.0 ( 2.5 )
    Notes
    [16] - Full Analysis Set
    [17] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.461 [18]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [18] - Independent samples t-test p-value

    Secondary: Disease free period

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    End point title
    		 Disease free period
    End point description
    Disease free period, evaluated as the time of occurrence of the first infectious episode after the end of the treatment cycles.
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [19]
    88 [20]
    Units: number
        number (confidence interval 95%)
    138.0 (126.5 to 149.5)
    128.1 (113.7 to 142.5)
    Notes
    [19] - Full Analysis Set
    [20] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.302
    Method
    		 Logrank
    Confidence interval

    Secondary: Use of anti-inflammatory

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    End point title
    		 Use of anti-inflammatory
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [21]
    88 [22]
    Units: number
        No
    56
    53
        Yes
    34
    35
    Notes
    [21] - Full Analysis Set
    [22] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.785
    Method
    		 Chi-squared
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Secondary: Use of bronchodilators

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    End point title
    		 Use of bronchodilators
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [23]
    88 [24]
    Units: number
        No
    79
    76
        Yes
    11
    12
    Notes
    [23] - Full Analysis Set
    [24] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.779
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Use of antibiotics

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    End point title
    		 Use of antibiotics
    End point description
    End point type
    Secondary
    End point timeframe
    Study period = 6 months
    End point values
    		 Buccalin placebo
    Number of subjects analysed
    90 [25]
    88 [26]
    Units: number
        No
    55
    57
        Yes
    35
    31
    Notes
    [25] - Full Analysis Set
    [26] - Full Analysis Set
    Statistical analysis title
    		 Secondary efficacy analysis
    Comparison groups
    Buccalin v placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.613
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study period = 6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Buccalin
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Buccalin placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 90 (1.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    Additional description: pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 90 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Buccalin placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 91 (18.68%)
    10 / 90 (11.11%)
    General disorders and administration site conditions
    Pyrexia
    Additional description: Fever
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 90 (3.33%)
         occurrences all number
    0
    6
    Chest pain
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: Gastric pain
         subjects affected / exposed
    5 / 91 (5.49%)
    2 / 90 (2.22%)
         occurrences all number
    5
    2
    Diarrhoea
         subjects affected / exposed
    4 / 91 (4.40%)
    0 / 90 (0.00%)
         occurrences all number
    4
    0
    Toothache
    Additional description: Tooth pain
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Influenza
    Additional description: Flu syndrome
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 90 (0.00%)
         occurrences all number
    2
    0
    Bronchitis
    Additional description: Acute bronchitis
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 90 (2.22%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Herpes zoster
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Pruritus allergic
    Additional description: Skin allergy
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 90 (1.11%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Bone pain
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 90 (1.11%)
         occurrences all number
    2
    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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    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
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