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    Clinical Trial Results:
    A Randomised, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of nasal spray ANTIRIN® and NASIC® in the Treatment of Acute Viral Rhinitis

    Summary
    EudraCT number
    		 2005-005876-33
    Trial protocol
    		 CZ  
    Global end of trial date
    17 Jul 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2016
    First version publication date
    16 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13/05/OXD/TP3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zentiva k.s
    Sponsor organisation address
    U kabelovny 130 , Praha 10 - Dolní Měcholupy, Czech Republic, 102 37
    Public contact
    MUDr. Tomas Hauser, Zentiva k.s., 00420 267243451, Tomas.Hauser@sanofi.com
    Scientific contact
    MUDr. Tomas Hauser, Zentiva k.s., 00420 267243451, Tomas.Hauser@sanofi.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
    17 Jul 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if the study drug ANTIRIN® is at least as effective (non-inferiority testing) assessed by TNSS changes after 4 days of therapy as the comparative product NASIC® in the treatment of acute viral rhinitis, to compare ANTIRIN® with placebo to proof of its efficacy and to compare NASIC® with placebo to proof assay sensitivity.
    Protection of trial subjects
    No specific measurements required
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    29 May 2006
    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
    Czech Republic: 221
    Country: Number of subjects enrolled
    Russian Federation: 32
    Worldwide total number of subjects
    253
    EEA total number of subjects
    221
    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)
    253
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 May 29, 2006 13 centres in Czech republic and 2 in Russia

    Pre-assignment
    Screening details
    		 inclusion/exclusion criteria check-list, medical history/ physical examination, laboratory examination: clinical chemistry, urinalysis, haematology, serology

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ANTIRIN
    Arm description
    		 This arm includes patients receiving ANTIRIN as a study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ANTIRIN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    0.1 mg of xylometazolin-hydrochlorid and 5.0 mg of dexpanthenol, 3x1 administration of spray/day into each nostril in horizontal position. 1 administration is one dose of spray into each nostril (0.1 ml, 0.1 g).

    Arm title
    		 NASIC
    Arm description
    		 This arm includes patients receiving NASIC as a study medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NASIC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    0.1 mg of xylometazolin-hydrochlorid and 5.0 mg of dexpanthenol, 3x1 administration of spray/day into each nostril in horizontal position. 1 administration is one dose of spray into each nostril (0.1 ml, 0.1 g).

    Arm title
    		 Placebo
    Arm description
    		 This arm includes patients receiving placebo as a study medication.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    0 mg of xylometazolin-hydrochlorid and 0 mg of dexpanthenol, 3x1 administration of spray/day into each nostril in horizontal position. 1 administration is one dose of spray into each nostril (0.1 ml, 0.1 g).

    Number of subjects in period 1 [1]
    		ANTIRIN NASIC Placebo
    Started
    81
    85
    84
    Completed
    81
    85
    84
    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: 250 subjects were administered study medication, 3 of original 253 subjects were not included into the study

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ANTIRIN
    Reporting group description
    		 This arm includes patients receiving ANTIRIN as a study medication.

    Reporting group title
    NASIC
    Reporting group description
    		 This arm includes patients receiving NASIC as a study medication.

    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes patients receiving placebo as a study medication.

    Reporting group values
    		 ANTIRIN NASIC Placebo Total
    Number of subjects
    		 81 85 84 250
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 81 85 84 250
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.827 ± 12.257 29.718 ± 10.884 29.548 ± 10.734 -
    Gender categorical
    Units: Subjects
        Female
    		 46 59 58 163
        Male
    		 35 26 26 87

    End points

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    End points reporting groups
    Reporting group title
    ANTIRIN
    Reporting group description
    		 This arm includes patients receiving ANTIRIN as a study medication.

    Reporting group title
    NASIC
    Reporting group description
    		 This arm includes patients receiving NASIC as a study medication.

    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes patients receiving placebo as a study medication.

    Primary: TNSS change

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    End point title
    		 TNSS change [1]
    End point description
    End point type
    Primary
    End point timeframe
    data analysed for the whole study period
    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: NA
    End point values
    		 ANTIRIN NASIC Placebo
    Number of subjects analysed
    81
    85
    84
    Units: TNSS
        arithmetic mean (standard error)
    -4.598 ± 0.237
    -4.612 ± 0.245
    -4.831 ± 0.214
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    assessment of the whole study period for each arm
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    ANTIRIN
    Reporting group description
    		 This arm includes patients receiving ANTIRIN as a study medication.

    Reporting group title
    NASIC
    Reporting group description
    		 This arm includes patients receiving NASIC as a study medication.

    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes patients receiving placebo as a study medication.

    Serious adverse events
    		 ANTIRIN NASIC Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ANTIRIN NASIC Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 84 (15.48%)
    8 / 86 (9.30%)
    4 / 83 (4.82%)
    Cardiac disorders
    Syncope
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 86 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    4
    4
    4
    Dizziness
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    1
    1
    1
    General disorders and administration site conditions
    Nasal discomfort
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    3
    3
    3
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Nausea
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 86 (4.65%)
    0 / 83 (0.00%)
         occurrences all number
    7
    7
    0
    Epistaxis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    1 / 83 (1.20%)
         occurrences all number
    2
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    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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    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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