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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled, Multi-centre Clinical Study to Investigate the Efficacy and Safety of Three Doses of Cineole in Subjects with Severe Acute Bronchitis with or without Associated Common Cold

    Summary
    EudraCT number
    		 2017-003044-20
    Trial protocol
    		 DE  
    Global end of trial date
    11 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CASK0117
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassella-med GmbH & Co. KG
    Sponsor organisation address
    Gereonsmuehlengasse 1, Cologne, Germany,
    Public contact
    Clinical Operations, Cassella-med GmbH & Co. KG, 49 8001652200, dialog@cassella-med.eu
    Scientific contact
    Clinical Operations, Cassella-med GmbH & Co. KG, clinical.operations@klosterfrau.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
    19 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is the dose-response behaviour of 600 mg, 900 mg and 1200 mg cineole in subjects with severe acute bronchitis with or without associated common cold.
    Protection of trial subjects
    After participation in the trial, patients have been treated with the current standard therapy for acute bronchitis. Furthermore, the use of rescue medication was allowed during the study period if deemed to be needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 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
    Germany: 181
    Worldwide total number of subjects
    181
    EEA total number of subjects
    181
    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)
    171
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were recruited from the pool of subjects who spontaneously visited their GP because of acute severe bronchitis.

    Pre-assignment
    Screening details
    		 Subjects were eligible for inclusion if the main criteria were met: - age between 18 and 65 years - acute bronchitis since ≤ 48 hours, with or without associated common cold; BSS > 12, indicating severe bronchitis - women of childbearing potential with negative pregnancy test and effective contraception - signed Informed Consent

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cineole 600mg/day
    Arm description
    		 For the 200 mg cineole per dose group (total of 600 mg/day), 1 capsule of Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Soledum® Kapseln forte 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered for the 200 mg cineole per dose group. All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Investigational medicinal product name
    Placebo capsules matching Soledum® Kapseln
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered for the 200 mg cineole per dose group. All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Arm title
    		 Cineole 900mg/day
    Arm description
    		 For the 300 mg cineole per dose group (total of 900 mg/day), 1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Soledum® Kapseln
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered for the 300 mg cineole per dose group (total of 900 mg/day). All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Investigational medicinal product name
    Soledum® Kapseln forte 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered for the 300 mg cineole per dose group (total of 900 mg/day), All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Investigational medicinal product name
    placecbo capsule matching Soledum® Kapseln
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Ocular use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered for the 300 mg cineole per dose group (total of 900 mg/day). All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Arm title
    		 Cineole 1200mg/day
    Arm description
    		 For the 400 mg cineole per dose group (total of 1200 mg/day), 1 capsule of Soledum® Kapseln forte and 2 capsules of Soledum® Kapseln were administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Soledum® Kapseln forte 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte and 2 capsules of Soledum® Kapseln were administered for the 400 mg cineole per dose group (total of 1200 mg/day). All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Investigational medicinal product name
    Soledum® Kapseln
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule of Soledum® Kapseln forte and 2 capsules of Soledum® Kapseln were administered for the 400 mg cineole per dose group (total of 1200 mg/day). All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Arm title
    		 Placebo
    Arm description
    		 For the placebo group, 1 placebo capsule matching Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo capsule matching Soledum® Kapseln
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule matching Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered for the placebo group. All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Investigational medicinal product name
    placebo capsule matching Soledum® Kapseln forte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule matching Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered for the placebo group. All 3 capsules were taken thrice daily (i.e., morning, noon, and evening - a total of 9 capsules per day) with plenty of liquid of moderate temperature (preferably 1 glass [200 mL] of drinking water), approximately 30 minutes before a regular meal.

    Number of subjects in period 1
    		Cineole 600mg/day Cineole 900mg/day Cineole 1200mg/day Placebo
    Started
    43
    46
    45
    47
    Treated
    43
    45
    43
    47
    Completed
    41
    41
    40
    44
    Not completed
    2
    5
    5
    3
         Consent withdrawn by subject
    1
    -
    3
    -
         Lack of patient cooperation
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    2
    1
    1
         Non-compliance with study medication
    -
    -
    -
    1
         Patient does not want a final examination
    -
    1
    -
    -
         Lost to follow-up
    -
    1
    1
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cineole 600mg/day
    Reporting group description
    		 For the 200 mg cineole per dose group (total of 600 mg/day), 1 capsule of Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.

    Reporting group title
    Cineole 900mg/day
    Reporting group description
    		 For the 300 mg cineole per dose group (total of 900 mg/day), 1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered.

    Reporting group title
    Cineole 1200mg/day
    Reporting group description
    		 For the 400 mg cineole per dose group (total of 1200 mg/day), 1 capsule of Soledum® Kapseln forte and 2 capsules of Soledum® Kapseln were administered.

    Reporting group title
    Placebo
    Reporting group description
    		 For the placebo group, 1 placebo capsule matching Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.

    Reporting group values
    		 Cineole 600mg/day Cineole 900mg/day Cineole 1200mg/day Placebo Total
    Number of subjects
    		 43 46 45 47 181
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Summary on age as continuous variable in the 4 treatment groups.
    Units: years
        arithmetic mean (full range (min-max))
    		 47.3 (19 to 65) 42.7 (18 to 77) 44.5 (18 to 79) 43.4 (18 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 26 25 23 17 91
        Male
    		 17 21 22 30 90
    Subject analysis sets

    Subject analysis set title
    FAS of the 600 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 600mg/day dose group.

    Subject analysis set title
    FAS of the 900 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 900 mg/day dose group

    Subject analysis set title
    FAS of the 1200 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 1200 mg/day dose group

    Subject analysis set title
    FAS of the placebo group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the Placebo group

    Subject analysis sets values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects
    43
    45
    43
    47
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Summary on age as continuous variable in the 4 treatment groups.
    Units: years
        arithmetic mean (full range (min-max))
    47.3 (19 to 65)
    42.7 (18 to 77)
    44.5 (18 to 79)
    43.4 (18 to 69)
    Gender categorical
    Units: Subjects
        Female
    26
    24
    22
    17
        Male
    17
    21
    21
    30

    End points

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    End points reporting groups
    Reporting group title
    Cineole 600mg/day
    Reporting group description
    		 For the 200 mg cineole per dose group (total of 600 mg/day), 1 capsule of Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.

    Reporting group title
    Cineole 900mg/day
    Reporting group description
    		 For the 300 mg cineole per dose group (total of 900 mg/day), 1 capsule of Soledum® Kapseln forte, 1 capsule Soledum® Kapseln, and 1 placebo capsule matching Soledum® Kapseln were administered.

    Reporting group title
    Cineole 1200mg/day
    Reporting group description
    		 For the 400 mg cineole per dose group (total of 1200 mg/day), 1 capsule of Soledum® Kapseln forte and 2 capsules of Soledum® Kapseln were administered.

    Reporting group title
    Placebo
    Reporting group description
    		 For the placebo group, 1 placebo capsule matching Soledum® Kapseln forte and 2 placebo capsules matching Soledum® Kapseln were administered.

    Subject analysis set title
    FAS of the 600 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 600mg/day dose group.

    Subject analysis set title
    FAS of the 900 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 900 mg/day dose group

    Subject analysis set title
    FAS of the 1200 mg/day dose group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the 1200 mg/day dose group

    Subject analysis set title
    FAS of the placebo group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set of the Placebo group

    Primary: Change/course of the bronchitis symptoms from Study Day 1 (baseline) until Study Day 5 and Day 8

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    End point title
    		 Change/course of the bronchitis symptoms from Study Day 1 (baseline) until Study Day 5 and Day 8 [1]
    End point description
    The primary efficacy variable was the change of the bronchitis Symptoms (reported by Principal Investigator) from the start of treatment (Study Day 1) until Study Day 5 and Study Day 8 represented by the sum score of the BBS. The primary analysis of the reported BBS scores was performed with the Full Analysis Set (FAS).
    End point type
    Primary
    End point timeframe
    Assessment at the start of treatment (Study Day 1) on Study Day 5 and on Study Day 8
    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: Primary efficacy analysis used an adjusted MCPMod approach on the LSMeans from the longitudinal modelling step to test for the existance of dose-related effects. The MCPMod tests have been conducted at a one-sided significance level of α=2.5%. All test procedures applied (exponential, EMax and SigEmax) resulted in non-significant p-values.
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    43
    45
    43
    47
    Units: BSS sum score
    least squares mean (standard error)
        Study Day 5
    -6.21 ± 0.46
    -5.74 ± 0.46
    -6.19 ± 0.47
    -6.34 ± 0.45
        Study Day 8
    -10.48 ± 0.47
    -9.26 ± 0.47
    -9.59 ± 0.47
    -10.43 ± 0.45
    No statistical analyses for this end point

    Secondary: Cough Severity, change from Study Day 1 (baseline) until Study Day 5 - on VAS

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    End point title
    		 Cough Severity, change from Study Day 1 (baseline) until Study Day 5 - on VAS
    End point description
    Severity of cough measured on a 100 mm Visual Analogue Scale (VAS) (ranging from 0 mm = no cough to 100 mm = worst cough ever) every day from inclusion - Study Day 1 and Study day 5.
    End point type
    Secondary
    End point timeframe
    Every day from inclusion (Study Day 1) until Study Day 5
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    42
    40
    44
    Units: mm
    arithmetic mean (standard deviation)
        Study Day 5
    -22.9 ± 20.34
    -19.5 ± 20.61
    -19.8 ± 20.67
    -26.8 ± 20.04
    No statistical analyses for this end point

    Secondary: Overall Efficacy Rating - 4 step rating scale on Study Day 5

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    End point title
    		 Overall Efficacy Rating - 4 step rating scale on Study Day 5
    End point description
    The Overall efficacy rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The efficacy rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    42
    40
    45
    Units: number
        0 - bad
    3
    5
    2
    2
        1 - satisfactory
    13
    17
    14
    9
        2 - good
    20
    12
    21
    26
        3 - very good
    6
    8
    3
    8
    No statistical analyses for this end point

    Secondary: Overall Efficacy Rating - 4 step rating scale on Study Day 8

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    End point title
    		 Overall Efficacy Rating - 4 step rating scale on Study Day 8
    End point description
    The Overall efficacy rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The efficacy rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    41
    41
    40
    45
    Units: number
        0 - bad
    1
    4
    3
    3
        1 - satisfactory
    10
    9
    11
    8
        2 - good
    20
    18
    21
    22
        3 - very good
    10
    10
    5
    12
    No statistical analyses for this end point

    Secondary: Complete Remission - BBS sum score ≤ 2

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    End point title
    		 Complete Remission - BBS sum score ≤ 2
    End point description
    Complete Remission was defined as BBS sum score ≤ 2 from the Investigator assessment on Study Days 5 and 8.
    End point type
    Secondary
    End point timeframe
    Study Day 5 and Study Day 8
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    42
    41
    45
    Units: number
        Study Day 5
    2
    3
    1
    2
        Study Day 8
    18
    13
    18
    22
    No statistical analyses for this end point

    Secondary: Cough Severity, change from Study Day 1 (baseline) until Study Day 8 - on VAS

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    End point title
    		 Cough Severity, change from Study Day 1 (baseline) until Study Day 8 - on VAS
    End point description
    Severity of cough measured on a 100 mm Visual Analogue Scale (VAS) (ranging from 0 mm = no cough to 100 mm = worst cough ever) every day from inclusion - Study Day 1 and Study Day 8.
    End point type
    Secondary
    End point timeframe
    Every day from inclusion (Study Day 1) until Study Day 8
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    26
    28
    25
    26
    Units: mm
    arithmetic mean (standard deviation)
        Study Day 8
    -45.5 ± 21.68
    -34.5 ± 31.06
    -33.7 ± 23.75
    -47.0 ± 24.82
    No statistical analyses for this end point

    Secondary: Cough Severity, change from Study Day 1 (baseline) until Study Day 5 - PI reported

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    End point title
    		 Cough Severity, change from Study Day 1 (baseline) until Study Day 5 - PI reported
    End point description
    Change from baseline in the per investigator reported BBS severity of cough, from inclusion - Study Day 1 and Study Day 5.
    End point type
    Secondary
    End point timeframe
    Every day from inclusion (Study Day 1) until Study Day 5
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    42
    40
    44
    Units: mm
    arithmetic mean (standard deviation)
        Study Day 5
    -1.4 ± 0.94
    -1.1 ± 0.78
    -1.2 ± 0.77
    -1.5 ± 0.98
    No statistical analyses for this end point

    Secondary: Cough Severity, change from Study Day 1 (baseline) until Study Day 8 - PI reported

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    End point title
    		 Cough Severity, change from Study Day 1 (baseline) until Study Day 8 - PI reported
    End point description
    Change from baseline in the per investigator reported BBS severity of cough, from inclusion - Study Day 1 and Study Day 8.
    End point type
    Secondary
    End point timeframe
    Every day from inclusion (Study Day 1) until Study Day 8
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    41
    41
    40
    44
    Units: mm
    arithmetic mean (standard deviation)
        Study Day 8
    -2.3 ± 0.95
    -1.9 ± 0.92
    -1.9 ± 1.02
    -2.4 ± 0.95
    No statistical analyses for this end point

    Secondary: Overall Tolerability Rating - 4 step rating scale on Study Day 5

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    End point title
    		 Overall Tolerability Rating - 4 step rating scale on Study Day 5
    End point description
    The Overall tolerability rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The tolerability rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    42
    40
    45
    Units: numbers
        0 - bad
    1
    0
    1
    0
        1 - satisfactory
    1
    1
    4
    1
        2 - good
    24
    25
    17
    21
        3 - very good
    16
    16
    18
    23
    No statistical analyses for this end point

    Secondary: Overall Tolerability Rating - 4 step rating scale on Study Day 8

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    End point title
    		 Overall Tolerability Rating - 4 step rating scale on Study Day 8
    End point description
    The overall tolerability rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The tolerability rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    41
    41
    40
    45
    Units: numbers
        0 - bad
    2
    0
    1
    0
        1 - satisfactory
    3
    2
    4
    1
        2 - good
    18
    20
    19
    16
        3 - very good
    18
    19
    16
    28
    No statistical analyses for this end point

    Secondary: Overall Tolerability Rating - 4 step rating scale on Study Day 14 ± 2

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    End point title
    		 Overall Tolerability Rating - 4 step rating scale on Study Day 14 ± 2
    End point description
    The overall tolerability rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The tolerability rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    43
    42
    47
    Units: numbers
        0 - bad
    0
    0
    2
    0
        1 - satisfactory
    3
    0
    5
    1
        2 - good
    21
    23
    21
    22
        3 - very good
    18
    20
    14
    24
    No statistical analyses for this end point

    Secondary: Overall Efficacy Rating - 4 step rating scale on Study Day 14 ± 2

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    End point title
    		 Overall Efficacy Rating - 4 step rating scale on Study Day 14 ± 2
    End point description
    The Overall efficacy rating was based on a verbal rating scale including 4 steps. The Investigator and the subject performed the assessment without knowing the other's rating. The efficacy rating was determined by the Investigator at Study Day 5, Study Day 8 and at Study Day 14 ± 2 and was determined by the subject on Study Days 2 to 8 and on Study Day 14 ± 2.
    End point type
    Secondary
    End point timeframe
    From Study Day 2 to Study Day 14 ± 2
    End point values
    		 FAS of the 600 mg/day dose group FAS of the 900 mg/day dose group FAS of the 1200 mg/day dose group FAS of the placebo group
    Number of subjects analysed
    42
    43
    42
    47
    Units: numbers
        0 - bad
    1
    3
    3
    2
        1 - satisfactory
    11
    9
    12
    7
        2 - good
    19
    24
    24
    27
        3 - very good
    11
    7
    3
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    after signing ICF (Study Day 1) and up to completion of the follow-up period (Study Day 14 ± 2) or, in case of premature withdrawal, up to the last Study Visit in an individual subject
    Adverse event reporting additional description
    ongoing AEs followed up for 15 days after the last study medication administration ongoing study medication-related AEs followed up until resolution, unless in investigator's opinion, the AE is unlikely to resolve due to the subject's underlying disease any new SAEs occurring up to 30 days after the last study medication administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Cineole 600 mg/day
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Cineole 1200 mg/day
    Reporting group description
    		 -

    Reporting group title
    Cineole 900 mg/day
    Reporting group description
    		 -

    Serious adverse events
    		 Cineole 600 mg/day Placebo Cineole 1200 mg/day Cineole 900 mg/day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (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
    		 Cineole 600 mg/day Placebo Cineole 1200 mg/day Cineole 900 mg/day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 43 (20.93%)
    2 / 47 (4.26%)
    10 / 43 (23.26%)
    8 / 45 (17.78%)
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 47 (2.13%)
    1 / 43 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    1
    2
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    3 / 43 (6.98%)
    0 / 45 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Constipation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    2 / 43 (4.65%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Eructation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal hypermotility
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    2 / 45 (4.44%)
         occurrences all number
    0
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    1 / 43 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 47 (2.13%)
    1 / 43 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    1
    1
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 47 (0.00%)
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    0
    0
    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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