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    Clinical Trial Results:
    Randomized, placebo-controlled, double-blind, cross-over trial with Bronchipret and Sinupret to evaluate acceleration of mucociliary clearance (MCC)

    Summary
    EudraCT number
    		 2012-004864-24
    Trial protocol
    		 BE  
    Global end of trial date
    27 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2023
    First version publication date
    06 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    COPD-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bionorica SE
    Sponsor organisation address
    Kerschensteinerstraße 11-15, Neumarkt, Germany, 92318
    Public contact
    Head of cooperate communication, Bionorica SE, info@bionorica.de
    Scientific contact
    Head of research and development, Bionorica SE, research.development@bionorica.de
    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
    09 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall aim of this trial was the proof of concept that the herbal drugs Bronchipret® and/or Sinupret® accelerate mucociliary clearance (MCC) of the respiratory tract.
    Protection of trial subjects
    This study was conducted in compliance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jun 2013
    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
    Belgium: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 67 screened subjects, 56 were randomised to one of the two treatments (Bronchipret® or Sinupret®). Of the 56 subjects, 28 subjects were treated with Bronchipret® and Bronchipret® placebo and 28 subjects were treated with Sinupret® and Sinupret® placebo. None of the screening failures were treated with trial medication.

    Pre-assignment
    Screening details
    		 Up to 14 days before subject’s randomisation to the treatment, a screening visit V 0 was performed to test subject’s general eligibility for the trial. It was supposed that trial subjects have already developed a mild to moderate impairment of mucociliary clearance due to their smoking habits.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Bronchipret Treatment
    Arm description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bronchipret®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 film coated tablets (FCTs) three times daily (TID) for 7 days (±1 day)

    Arm title
    		 Sinupret Treatment
    Arm description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sinupret® extract mite
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 coated tablets (CTs) TID for 7 days (±1 day)

    Arm title
    		 Bronchipret-Placebo Treatment
    Arm description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Bronchipret® placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 film coated tablets (FCTs) three times daily (TID) for 7 days (±1 day)

    Arm title
    		 Sinupret-Placebo Treatment
    Arm description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sinupret Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 coated tablets TID for 7 days (±1 day)

    Number of subjects in period 1
    		Bronchipret Treatment Sinupret Treatment Bronchipret-Placebo Treatment Sinupret-Placebo Treatment
    Started
    28
    28
    28
    28
    End of treatment with Verum
    28
    28
    28
    28
    End of wash-out period
    28
    28
    28
    28
    End of treatment with Placebo
    28
    28
    28
    28
    Completed
    28
    28
    28
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bronchipret Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Sinupret Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Bronchipret-Placebo Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Sinupret-Placebo Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).

    Reporting group values
    		 Bronchipret Treatment Sinupret Treatment Bronchipret-Placebo Treatment Sinupret-Placebo Treatment Total
    Number of subjects
    		 28 28 28 28 56
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 28 28 28 28 56
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.6 ( 5.2 ) 30.9 ( 3.8 ) 32.6 ( 5.2 ) 30.9 ( 3.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 12 15 12 27
        Male
    		 13 16 13 16 29
    Subject analysis sets

    Subject analysis set title
    Bronchipret-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS for the efficacy analysis included all randomised subjects with at least one documented application of the investigational drug and evaluable saccharin tests at the beginning and end of the active treatment period and the beginning and end of the corresponding placebo period.

    Subject analysis set title
    Bronchipret-PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population for the efficacy analysis included all FAS subjects who did not show protocol deviations which could have a relevant influence on the assessment of the primary endpoint. To be accountable for the PP population a trial subject took 80 – 120% of IMP during each of the both treatment periods and the last three scheduled doses of IMP prior to the saccharin test at the end of treatment period 1 (V 2) and the end of treatment period 2 (V 4).

    Subject analysis set title
    Sinupret-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS for the efficacy analysis included all randomised subjects with at least one documented application of the investigational drug and evaluable saccharin tests at the beginning and end of the active treatment period and the beginning and end of the corresponding placebo period.

    Subject analysis set title
    Sinupret-PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population for the efficacy analysis included all FAS subjects who did not show protocol deviations which could have a relevant influence on the assessment of the primary endpoint. To be accountable for the PP population a trial subject took 80 – 120% of IMP during each of the both treatment periods and the last three scheduled doses of IMP prior to the saccharin test at the end of treatment period 1 (V 2) and the end of treatment period 2 (V 4).

    Subject analysis sets values
    		 Bronchipret-FAS Bronchipret-PP Sinupret-FAS Sinupret-PP
    Number of subjects
    28
    25
    28
    21
    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)
    28
    25
    28
    21
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.6 ( 5.2 )
    32.8 ( 5.3 )
    30.9 ( 3.8 )
    31.1 ( 4.0 )
    Gender categorical
    Units: Subjects
        Female
    15
    15
    12
    9
        Male
    13
    10
    16
    12

    End points

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    End points reporting groups
    Reporting group title
    Bronchipret Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Sinupret Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Bronchipret-Placebo Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group A: Treatment period 1: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day). Group B: Treatment period 1: 2 FCTs of Bronchipret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Bronchipret® (verum) TID for 7 days (±1 day).

    Reporting group title
    Sinupret-Placebo Treatment
    Reporting group description
    		 At Visit 1 (Day 0), subjects were randomly assigned to the following blinded treatment groups: Group C: Treatment period 1: 2 CTs of Sinupret® (verum) TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 CTs of Sinupret® placebo TID for 7 days (±1 day). Group D: Treatment period 1: 2 CTs of Sinupret® placebo TID for 7 days (±1 day), Wash-out for 7 days (+7 days), Treatment period 2: 2 FCTs of Sinupret® (verum) TID for 7 days (±1 day).

    Subject analysis set title
    Bronchipret-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS for the efficacy analysis included all randomised subjects with at least one documented application of the investigational drug and evaluable saccharin tests at the beginning and end of the active treatment period and the beginning and end of the corresponding placebo period.

    Subject analysis set title
    Bronchipret-PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population for the efficacy analysis included all FAS subjects who did not show protocol deviations which could have a relevant influence on the assessment of the primary endpoint. To be accountable for the PP population a trial subject took 80 – 120% of IMP during each of the both treatment periods and the last three scheduled doses of IMP prior to the saccharin test at the end of treatment period 1 (V 2) and the end of treatment period 2 (V 4).

    Subject analysis set title
    Sinupret-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS for the efficacy analysis included all randomised subjects with at least one documented application of the investigational drug and evaluable saccharin tests at the beginning and end of the active treatment period and the beginning and end of the corresponding placebo period.

    Subject analysis set title
    Sinupret-PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population for the efficacy analysis included all FAS subjects who did not show protocol deviations which could have a relevant influence on the assessment of the primary endpoint. To be accountable for the PP population a trial subject took 80 – 120% of IMP during each of the both treatment periods and the last three scheduled doses of IMP prior to the saccharin test at the end of treatment period 1 (V 2) and the end of treatment period 2 (V 4).

    Primary: Relative time to perception of sweetness after 7 days treatment with Bronchipret

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    End point title
    		 Relative time to perception of sweetness after 7 days treatment with Bronchipret [1]
    End point description
    The primary endpoint was defined as the time to perception of sweetness following the placement of a particle of sodium saccharin on the surface of the inferior nasal concha after 7 days of oral treatment with the investigational products or placebo - relative to the time to perception of sweetness at the beginning of treatment.
    End point type
    Primary
    End point timeframe
    The relative time to perception of sweetness (tps) after 7 days of treatment with the investigational products (relative to the tps before the beginning of treatment) in each treatment period is defined as the primary endpoint.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The overall aim of this trial was to demonstrate the superiority of Bronchipret® and/or Sinupret® over placebo regarding acceleration of MCC . Therefore, 2 analyses were performed for the primary endpoint: one comparing the treatment with Bronchipret vs. Bronchipret placebo and another one comparing the treatment with Sinupret vs. Sinupret placebo regarding the acceleration of MCC.
    End point values
    		 Bronchipret Treatment Bronchipret-Placebo Treatment
    Number of subjects analysed
    25
    25
    Units: seconds
        arithmetic mean (standard deviation)
    101.2 ( 59.2 )
    111.6 ( 59.1 )
    Statistical analysis title
    		 Treatment difference of Bronchipret® and placebo
    Statistical analysis description
    Treatment difference of Bronchipret® and placebo on relative time to perception of sweetness after 7 days treatment tested by ANOVA
    Comparison groups
    Bronchipret Treatment v Bronchipret-Placebo Treatment
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.364
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.16

    Primary: Relative time to perception of sweetness after 7 days treatment with Sinupret

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    End point title
    		 Relative time to perception of sweetness after 7 days treatment with Sinupret [2]
    End point description
    The primary endpoint was defined as the time to perception of sweetness following the placement of a particle of sodium saccharin on the surface of the inferior nasal concha after 7 days of oral treatment with the investigational products or placebo - relative to the time to perception of sweetness at the beginning of treatment.
    End point type
    Primary
    End point timeframe
    The relative time to perception of sweetness (tps) after 7 days of treatment with the investigational products (relative to the tps before the beginning of treatment) in each treatment period is defined as the primary endpoint.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The overall aim of this trial was to demonstrate the superiority of Bronchipret® and/or Sinupret® over placebo regarding acceleration of MCC . Therefore, 2 analyses were performed for the primary endpoint: one comparing the treatment with Bronchipret vs. Bronchipret placebo and another one comparing the treatment with Sinupret vs. Sinupret placebo regarding the acceleration of MCC.
    End point values
    		 Sinupret Treatment Sinupret-Placebo Treatment
    Number of subjects analysed
    21
    21
    Units: seconds
        arithmetic mean (standard deviation)
    128.6 ( 91.2 )
    107.8 ( 57.2 )
    Statistical analysis title
    		 Relative tps after 7 days treatment
    Statistical analysis description
    Treatment difference of Sinupret® and placebo on relative time to perception of sweetness tested by ANOVA
    Comparison groups
    Sinupret Treatment v Sinupret-Placebo Treatment
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.51

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs during the treatment period are reported. All AEs occurring during wash-out periods were added to the preceding active treatment or placebo period, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Sinupret-Placebo Treatment
    Reporting group description
    		 -

    Reporting group title
    Sinupret Treatment
    Reporting group description
    		 -

    Reporting group title
    Bronchipret Treatment
    Reporting group description
    		 -

    Reporting group title
    Bronchipret-Placebo Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Sinupret-Placebo Treatment Sinupret Treatment Bronchipret Treatment Bronchipret-Placebo Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sinupret-Placebo Treatment Sinupret Treatment Bronchipret Treatment Bronchipret-Placebo Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 28 (53.57%)
    13 / 28 (46.43%)
    15 / 28 (53.57%)
    18 / 28 (64.29%)
    Vascular disorders
    Haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Surgical and medical procedures
    Mole excision
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Reproductive system and breast disorders
    Breast inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspnoea exertional
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased upper airway secretion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nasal obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    1
    1
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
         occurrences all number
    0
    1
    1
    2
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Upper-airway cough syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    1
    Psychiatric disorders
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    4
    3
    Injury, poisoning and procedural complications
    Muscle rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wound
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 28 (17.86%)
    5 / 28 (17.86%)
    5 / 28 (17.86%)
    3 / 28 (10.71%)
         occurrences all number
    5
    5
    6
    3
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Eye pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Eye swelling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    1
    2
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    0
    0
    2
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 28 (10.71%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
         occurrences all number
    1
    3
    1
    2
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Flatulence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    1 / 28 (3.57%)
         occurrences all number
    1
    2
    2
    1
    Frequent bowel movements
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Gingival inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoids
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    1
    Reflux gastritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperhidrosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    0
    2
    Oral herpes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    1
    Pulpitis dental
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2013
    The Amendment No. 1 was necessary to implement that the inclusion criterion number 4 is proven by assessing ability to taste sweetness of saccharin on the basis of saccharin test (perception of sweetness within 30 minutes after placement of saccharin behind nasal valve) at V 0. Therefore, placing saccharin particles on the tongue for the “assessment of the ability to taste sweetness of saccharin” as required by protocol at V 0 was not necessary and was deleted. Due to the fact that the taste of saccharin can persist a certain time, it is not adequate to apply saccharin on tongue shortly prior the saccharin test. Furthermore some editorial corrections for clarification were done. Additionally, the planned time lines of trial conduct were adapted. These changes had no substantial implications on the scientific value of the trial, the conduct of the trial or the safety of the trial subjects.

    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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