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    Clinical Trial Results:
    Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months.

    Summary
    EudraCT number
    		 2016-000979-24
    Trial protocol
    		 IT  
    Global end of trial date
    05 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2023
    First version publication date
    28 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DSIT-2015-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo Italia SpA
    Sponsor organisation address
    Via Paolo di Dono, 73, Roma, Italy,
    Public contact
    Dott. Fabio Romeo,Medical Director, Daiichi Sankyo Italia SpA, +39 0685255, fabio.romeo@daiichi-sankyo.it
    Scientific contact
    Dott. Fabio Romeo,Medical Director, Daiichi Sankyo Italia SpA, +39 0685255, fabio.romeo@daiichi-sankyo.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
    05 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the clinical efficacy of Paspat 3 mg tablets in preventing, number and severity of recurring infections of the upper respiratory tract in children at risk, testified by at least six recurrences in the previous 12 months
    Protection of trial subjects
    The only versione 1.0 of the protocol (18 Apr 2016), was generated, approved and in force in all sites. Regulatory procedures including IEC/CA submission were carried out by the CRO through the on-line Regulatory Platform (OsSC) set by AIFA. Having obtained the favourable opinion from the competent ECs, CEC (on 21June2016) and following the approval of the Competent Authority (CA) on 06Jul2016, sites were initiated This study was conducted in compliance with specific regulatory requirements of the Italian Ministry of Health, including D.lgs 24 June 2003 no. 211, DPR 21 September 2001 no. 439, DM 26 April 2002, DM 21 December2007, DM 13 September 2012, Determina AIFA 07 January 2013, Determina AIFA 809/2015. This trial was conducted in compliance with the most recent version of the Declaration of Helsinki (Fortaleza, Brazil, October 2013), the most recent version of the Good Clinical Practice (GCP), and all applicable regulatory requirements (European Directive 2001/20/EC, 04 April 2001), and Italian Laws(D.lgs no. 211, 24 June 2003 and all applicable regulations).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2017
    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: 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)
    178
    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
    		 The study was conducted in Italy, by involving 4 Italian pediatric hospitals and 2 Italian health districts that involved 23 Italian Pediatricians. Dr. Oliviero Sacco (IRCCS Istituto Giannina Gaslini, Genova) acted as national study coordinator. The recruitment was fractionated in two consecutive campaigns (01/09/2017-12/02/2018 and 01/03/2019)

    Pre-assignment
    Screening details
    		 The first patient of the first campaign was randomized on 01 September 2017 and the last one on 12 February 2018, when 119 patients, 57.1% of the planned target, were enrolled. The second wave started on 01 September 2018 and the recruitment continued until 31 March 2019.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 paspat
    Arm description
    		 a) First treatment period of 28 days b) Off-drug period of 28 days c) Second treatment period of 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    PASPAT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 mg/ daily- whole tablet, away from meals

    Arm title
    		 placebo
    Arm description
    		 3mg tablet a) First treatment period of 28 days b) Off-drug period of 28 days c) Second treatment period of 28 days
    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
    3 mg/ daily- whole tablet, away from meals

    Number of subjects in period 1 [1]
    		paspat placebo
    Started
    84
    89
    Completed
    75
    86
    Not completed
    9
    3
         Physician decision
    1
    -
         Subject's decision
    2
    1
         Lost to follow-up
    1
    -
         various reasons
    5
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The 178 screened patients were allocated to the treatment groups as follows: 84 received Paspat and 89 received placebo. Four patients allocated in the Paspat group (4.5%) and one in the placebo group (1.1%) did not take any treatment were excluded from FAS analysis that consists of 173 subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 173 173
    Age categorical
    Out of 173 subjects in FAS, 94 (54.3%) were males and 79 (45.7%) females that were slightly unbalanced in the two groups (52.4% females in Paspat vs 39.4% in placebo group). All but three patients were of Caucasian ethnic origin (96.5%). The age was ranged from 2.6 to 7.0 years, well balanced between groups, with means of 5.0 (± 0.8) and 5.1 (± 0.8) in the Paspat and placebo groups, respectively.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 173 173
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 79 79
        Male
    		 94 94

    End points

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    End points reporting groups
    Reporting group title
    paspat
    Reporting group description
    		 a) First treatment period of 28 days b) Off-drug period of 28 days c) Second treatment period of 28 days

    Reporting group title
    placebo
    Reporting group description
    		 3mg tablet a) First treatment period of 28 days b) Off-drug period of 28 days c) Second treatment period of 28 days

    Primary: efficacy

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    End point title
    		 efficacy
    End point description
    End point type
    Primary
    End point timeframe
    over the 6 months of the observation period
    End point values
    		 paspat placebo
    Number of subjects analysed
    79
    87
    Units: number of episodes URTIs
        number (not applicable)
    49
    55
    Statistical analysis title
    		 mean of number of episodes URTIs
    Comparison groups
    paspat v placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.94
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Regarding the primary endpoint in the FAS population, 104 patients (62.7%) out of 166 completing 6-months observation period had no episode of URTI, 49 out of 79 in the Paspat group (62.0%) and 55 out of 87 in the placebo group (63.2%). Details shown in Table XVII (Chi square test p = 0.94).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    summary AE
    Reporting group description
    		 During the study period, 676 AEs were recorded in 119 patients: 329 AEs (48.7%) in 63 patients in the Paspat group and 347 AEs (51.3%) in 56 assuming placebo. Analysing all AEs, only one out of 675 AEs was reported as serious adverse event (SAE) in the placebo group and not related to the study drug. A total of 524 (79.0%) AEs were considered mild, 73.2% in the Paspat group and 84.4% in the placebo group. Moderate AEs were found in 84 (25.5%) vs 53 (15.2%) patients in Paspat and placebo group respectively. Four severe AEs (1.2%) were all reported in the Paspat group. No AE was considered related to the treatment in both groups. Two AEs (0.6%), 2 episodes of diarrhoea in the same patient in the Paspat group, were considered possibly related and 2 AEs in each group were considered unlikely related to the treatment. The vast majority of the AEs 324 (98.5%) and 344 (99.1) in the Paspat and placebo group respectively, was not considered treatment related.

    Serious adverse events
    		 summary AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 119 (0.84%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Adenotonsillectomy
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 summary AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    119 / 119 (100.00%)
    Vascular disorders
    Vascular disorders
    Additional description: Haematoma
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences all number
    1
    General disorders and administration site conditions
    General disorders and administrations
         subjects affected / exposed
    23 / 119 (19.33%)
         occurrences all number
    23
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastin
    Additional description: Asthma Bronchitis Bronchospasm Cough Epistaxis Influenza Irregular breathing Laryngitis Nasal congestion Nasal obstruction Nasopharyngitis Oropharyngeal pain Pharyngitis Pharyngitis streptococcal Pharyngotonsillitis Pneumo
         subjects affected / exposed
    115 / 119 (96.64%)
         occurrences all number
    333
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural
    Additional description: Joint injury Tympanic membrane perforation
         subjects affected / exposed
    2 / 119 (1.68%)
         occurrences all number
    2
    Nervous system disorders
    Nervous system disorders
    Additional description: Headache
         subjects affected / exposed
    2 / 119 (1.68%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: Lymphadenitis Lymphadenopathy
         subjects affected / exposed
    2 / 119 (1.68%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Ear and labyrinth disorders
    Additional description: Ear infection, Ear pain, Otitis media,Otitis media acute,Tympanic membrane hyperaemia
         subjects affected / exposed
    36 / 119 (30.25%)
         occurrences all number
    44
    Eye disorders
    Eye disorders
    Additional description: Conjunctivitis
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: Abdominal pain Dental caries Diarrhoea Dysphagia Gastroenteritis Nausea Vomiting
         subjects affected / exposed
    25 / 119 (21.01%)
         occurrences all number
    30
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disease
    Additional description: Dermatitis Skin lesion Urticaria Varicella
         subjects affected / exposed
    9 / 119 (7.56%)
         occurrences all number
    10
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: Cystitis Dysuria
         subjects affected / exposed
    3 / 119 (2.52%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissues
    Additional description: Arthralgia Musculoskeletal discomfort Synovitis
         subjects affected / exposed
    3 / 119 (2.52%)
         occurrences all number
    3
    Infections and infestations
    Infections and infestations
    Additional description: Enterobiasis Infectious mononucleosis Localised infection
         subjects affected / exposed
    4 / 119 (3.36%)
         occurrences all number
    4

    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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