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    Clinical Trial Results:
    Investigation of the efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in adult patients with acute bronchitis. A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase IV clinical trial.

    Summary
    EudraCT number
    		 2018-001395-37
    Trial protocol
    		 DE  
    Global end of trial date
    10 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2022
    First version publication date
    06 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Repha_1430
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Repha GmbH
    Sponsor organisation address
    Alt-Godshorn 87, Langenhagen, Germany, 30855
    Public contact
    Clinical Research, Mediconomics GmbH, 0049 05115609980, info@mediconomics.com
    Scientific contact
    Clinical Research, Mediconomics GmbH, 0049 05115609980, info@mediconomics.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
    10 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy, safety and tolerability of ANGOCIN® Anti-Infekt N versus placebo in the treatment of acute bronchitis.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice (GCP), which has its origins in the Declaration of Helsinki, and in strict compliance with the German German Drug Law (AMG) and the German Federal Data Protection Act (BDSG), in order to protect the rights, safety and well-being of patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2018
    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: 384
    Worldwide total number of subjects
    384
    EEA total number of subjects
    384
    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)
    372
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A 10-day treatment with a total of 4 visits was planned for each patient. On day 0, visit 1, at which the baseline BSSinv was determined and randomisation took place, the patients were given the study medication. The course of the disease was assessed by the investigator during each visit.

    Pre-assignment
    Screening details
    		 All patients who appeared suitable for the clinical trial according to the inclusion and exclusion criteria and who had given their written consent to participate in the clinical trial were entered in the patient identification log on visit 1 (day 0). Subjects were assigned a consecutive patient identification number.

    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Blinding of investigator and patient was achieved by the following measures: Verum and placebo did not differ visually, There was no information on the name and strength of the study medication on the blisters and secondary packaging, The study medication of the two study arms was labelled with the same batch designation and expiry date; traceability was ensured via the randomisation number and the manufacturing documentation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational product
    Arm description
    		 3x4 film coated tablets daily, 10 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Angocin Anti-Infekt N
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x4 film coated tablets daily, 10 days

    Arm title
    		 Placebo
    Arm description
    		 3x4 film coated tablets daily, 10 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x4 film coated tablets daily, 10 days

    Number of subjects in period 1
    		Investigational product Placebo
    Started
    195
    189
    Completed
    191
    188
    Not completed
    4
    1
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment phase Total
    Number of subjects
    		 384 384
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 372 372
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 250 250
        Male
    		 134 134

    End points

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    End points reporting groups
    Reporting group title
    Investigational product
    Reporting group description
    		 3x4 film coated tablets daily, 10 days

    Reporting group title
    Placebo
    Reporting group description
    		 3x4 film coated tablets daily, 10 days

    Primary: Change of BSSinv Visit 1-Visit 3

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    End point title
    		 Change of BSSinv Visit 1-Visit 3
    End point description
    Symptomscore of bronchitis (BSS) as assessed by the investigator as summary score of cough, mucous production, chest pain, rales and dyspnea as a difference between visit 3 (day 7) as opposed to baseline, ITT
    End point type
    Primary
    End point timeframe
    Comparison of the Change within the mean BSSinv (Baseline to Day 7) between both Treatment groups
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS
    arithmetic mean (standard deviation)
        Visit 1
    7.4 ( 1.9 )
    7.3 ( 1.9 )
        Visit 2
    6.2 ( 2.1 )
    6.6 ( 2.3 )
        Visit 3
    3.5 ( 2.0 )
    4.3 ( 2.4 )
    Statistical analysis title
    		 BSSinv total Visit 3
    Comparison groups
    Placebo v Investigational product
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 ANCOVA primary endpoint ITT
    Statistical analysis description
    The co-variate analysis of the difference in bronchitis symptom score with baseline as covariate in the ITT set showed a p-value of p=0.000243 (the treatment effect is 0.81 score-units with a standard error of 0.22 units),meaning a superioroty of Angocin vs. placebo in the decrease of the bronchitis symptom score. The results of the primary endpoint show superiority of Angocin also in the per protocol set, with p=0.000119 (treatment effect 0.76 score-units with a standard error of 0.20 units)
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.000243 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - mixed model, ITT
    Statistical analysis title
    		 ANCOVA primary endpoint PP
    Statistical analysis description
    The co-variate analysis of the difference in bronchitis symptom score with baseline as covariate in th eITT set showed a p-value of p=0.000243 (the treatment effect is 0.81 score-units with a standard error of 0.22 units),meaning a superioroty of Angocin vs. placebo in the decrease of the bronchitis symptom score. The results of the primary endpoint show superiority of Angocin also in the per protocol set, with p=0.000119 (treatment effect 0.76 score-units with a standard error of 0.20 units)
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.000119 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - mixed model, PP

    Secondary: Difference of mean BSS total symptomscore between V1 (Baseline) and V2

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    End point title
    		 Difference of mean BSS total symptomscore between V1 (Baseline) and V2
    End point description
    Symptomscore of bronchitis (BSS) as assessed by the investigator as summary score of cough, mucous production, chest pain, rales and dyspnea as a difference between visit 2 (day 7) as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS
        arithmetic mean (standard deviation)
    -1.2 ( 1.6 )
    -0.7 ( 2.0 )
    Statistical analysis title
    		 BSS total V1-V2
    Statistical analysis description
    Mean of difference values (Visit 2 -minus- baseline)
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference of mean BSS total symptomscore between V1 (Baseline) and V4

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    End point title
    		 Difference of mean BSS total symptomscore between V1 (Baseline) and V4
    End point description
    Symptomscore of bronchitis (BSS) as assessed by the investigator as summary score of cough, mucous production, chest pain, rales and dyspnea as a difference between visit 4 (day 7) as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS
        arithmetic mean (standard deviation)
    -5.7 ( 2.4 )
    -4.9 ( 3.1 )
    Statistical analysis title
    		 BSS total V1-V4
    Statistical analysis description
    Mean of difference values (Visit 4 -minus- baseline)
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS cough Visit 1 and Visit 2

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    End point title
    		 Difference mean BSS cough Visit 1 and Visit 2
    End point description
    Symptomscore of bronchitis (BSS), symptom cough as assessed by the investigator as a difference between visit 2 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Visit 1 and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS cough
        arithmetic mean (standard deviation)
    -0.3 ( 0.6 )
    -0.2 ( 0.6 )
    Statistical analysis title
    		 BSS cough Visit 1-Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.037
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS cough Visit 1 and Visit 3

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    End point title
    		 Difference mean BSS cough Visit 1 and Visit 3
    End point description
    Symptomscore of bronchitis (BSS), symptom cough as assessed by the investigator as a difference between visit 3 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Basleine (Visit 1) and Visit 3
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS cough
        arithmetic mean (standard deviation)
    -0.9 ( 0.8 )
    -0.7 ( 0.8 )
    Statistical analysis title
    		 BSS cough Visit 1-Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.03
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS cough Visit 1 and Visit 4

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    End point title
    		 Difference mean BSS cough Visit 1 and Visit 4
    End point description
    Symptomscore of bronchitis (BSS), symptom cough as assessed by the investigator as a difference between visit 4 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS
        arithmetic mean (standard deviation)
    -1.5 ( 0.8 )
    -1.3 ( 1.0 )
    Statistical analysis title
    		 BSScough Visit 1-Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.018
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS mucous Visit 1 and Visit 2

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    End point title
    		 Difference mean BSS mucous Visit 1 and Visit 2
    End point description
    Symptomscore of bronchitis (BSS), symptom mucous as assessed by the investigator as a difference between visit 2 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS mucous
        arithmetic mean (standard deviation)
    -0.1 ( 0.6 )
    0.0 ( 0.6 )
    Statistical analysis title
    		 BSSmucous Visit 1-Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.074
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS mucous Visit 1 and Visit 3

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    End point title
    		 Difference mean BSS mucous Visit 1 and Visit 3
    End point description
    Symptomscore of bronchitis (BSS), symptom mucous as assessed by the investigator as a difference between visit 3 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 3
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolut values of BSSmucous
        arithmetic mean (standard deviation)
    -0.8 ( 0.8 )
    -0.5 ( 0.9 )
    Statistical analysis title
    		 BSSmucous Visit 1-Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS mucous Visit 1 and Visit 4

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    End point title
    		 Difference mean BSS mucous Visit 1 and Visit 4
    End point description
    Symptomscore of bronchitis (BSS), symptom mucous as assessed by the investigator as a difference between visit 4 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values BSSmucous
        arithmetic mean (standard deviation)
    -1.5 ( 0.8 )
    -1.1 ( 1.0 )
    Statistical analysis title
    		 BSSmucous Visit 1-Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS chest pain Visit 1 and Visit 2

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    End point title
    		 Difference mean BSS chest pain Visit 1 and Visit 2
    End point description
    Symptomscore of bronchitis (BSS), symptom chest pain as assessed by the investigator as a difference between visit 2 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS chestpain
        arithmetic mean (standard deviation)
    -0.4 ( 0.6 )
    -0.2 ( 0.7 )
    Statistical analysis title
    		 BSSchestpain Visit 1-Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS chest pain Visit 1 and Visit 3

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    End point title
    		 Difference mean BSS chest pain Visit 1 and Visit 3
    End point description
    Symptomscore of bronchitis (BSS), symptom chest pain as assessed by the investigator as a difference between visit 3 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 3
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS chestpain
        arithmetic mean (standard deviation)
    -0.9 ( 0.9 )
    -0.7 ( 0.9 )
    Statistical analysis title
    		 BSSchestpain Visit 1-Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS chest pain Visit 1 and Visit 4

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    End point title
    		 Difference mean BSS chest pain Visit 1 and Visit 4
    End point description
    Symptomscore of bronchitis (BSS), symptom chest pain as assessed by the investigator as a difference between visit 4 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute value of BSS chest pain
        arithmetic mean (standard deviation)
    -1.2 ( 0.8 )
    -1.1 ( 0.9 )
    Statistical analysis title
    		 BSSchestpain Visit 1-Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.024
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS rales Visit 1 and Visit 2

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    End point title
    		 Difference mean BSS rales Visit 1 and Visit 2
    End point description
    Symptomscore of bronchitis (BSS), symptom rales as assessed by the investigator as a difference between visit 2 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values of BSS rales
        arithmetic mean (standard deviation)
    -0.1 ( 0.4 )
    -0.1 ( 0.6 )
    Statistical analysis title
    		 BSSrales Visit 1-Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.415
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS rales Visit 1 and Visit 3

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    End point title
    		 Difference mean BSS rales Visit 1 and Visit 3
    End point description
    Symptomscore of bronchitis (BSS), symptom rales as assessed by the investigator as a difference between visit 3 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 3
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute vlalues BSS rales
        arithmetic mean (standard deviation)
    -0.6 ( 0.6 )
    -0.5 ( 0.8 )
    Statistical analysis title
    		 BSSrales Visit 1-Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.229
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS rales Visit 1 and Visit 4

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    End point title
    		 Difference mean BSS rales Visit 1 and Visit 4
    End point description
    Symptomscore of bronchitis (BSS), symptom rales as assessed by the investigator as a difference between visit 4 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute value BSS rales
        arithmetic mean (standard deviation)
    -0.7 ( 0.7 )
    -0.6 ( 0.8 )
    Statistical analysis title
    		 BSSrales Visit 1-Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.521
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS dyspnoea Visit 1 and Visit 2

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    End point title
    		 Difference mean BSS dyspnoea Visit 1 and Visit 2
    End point description
    Symptomscore of bronchitis (BSS), symptom dyspnea as assessed by the investigator as a difference between visit 2 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 2
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute values BSS dyspnoea
        arithmetic mean (standard deviation)
    -0.3 ( 0.6 )
    -0.2 ( 0.6 )
    Statistical analysis title
    		 BSSdyspnoea Visit 1-Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.241
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS dyspnoea Visit 1 and Visit 3

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    End point title
    		 Difference mean BSS dyspnoea Visit 1 and Visit 3
    End point description
    Symptomscore of bronchitis (BSS), symptom dyspnoea as assessed by the investigator as a difference between visit 3 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 3
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute value BSS dyspnoea
        arithmetic mean (standard deviation)
    -0.6 ( 0.7 )
    -0.6 ( 0.8 )
    Statistical analysis title
    		 BSSdyspnoea Visit 1-Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.587
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Difference mean BSS dyspnoea Visit 1 and Visit 4

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    End point title
    		 Difference mean BSS dyspnoea Visit 1 and Visit 4
    End point description
    Symptomscore of bronchitis (BSS), symptom dyspnoea as assessed by the investigator as a difference between visit 4 as opposed to baseline
    End point type
    Secondary
    End point timeframe
    Between Baseline (Visit 1) and Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Absolute value BSS dyspnoea
        arithmetic mean (standard deviation)
    -0.8 ( 0.7 )
    -0.8 ( 0.8 )
    Statistical analysis title
    		 BSSdyspnoea Visit 1-Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.495
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Rate of patients who underwent antibiotic therapy for the treatment of acute bronchitis between V1 and V4 (Antibiotic rate).

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    End point title
    		 Rate of patients who underwent antibiotic therapy for the treatment of acute bronchitis between V1 and V4 (Antibiotic rate).
    End point description
    Patients with antibiotic or analgesic mediaction were counted and ompared between arms. Overall numbers were too low to evaluate significance levels.
    End point type
    Secondary
    End point timeframe
    Therapy phase
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: number of patients
        Antibiotics
    0
    2
        Analgetics
    16
    23
    No statistical analyses for this end point

    Secondary: Responder rate Visit 1 - Visit 4

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    End point title
    		 Responder rate Visit 1 - Visit 4
    End point description
    Patients whose symptoms had improved in the BSS or who were cured were classified as "responders".
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: number of patients
        Visit 2
    120
    82
        Visit 3
    181
    164
        Visit 4
    188
    178
    Statistical analysis title
    		 Responder rate Visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Responder rate Visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Responder rate Visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.301
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Non-Responder rate

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    End point title
    		 Non-Responder rate
    End point description
    Patients whose symptoms were unchanged or had worsened were classified as "non-responders".
    End point type
    Secondary
    End point timeframe
    Visit 1 - Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: number of patients
        Visit 2
    78
    113
        Visit 3
    12
    26
        Visit 4
    4
    11
    Statistical analysis title
    		 Non-responder rate visit 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Non-responder rate visit 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.015
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Non-responder rate visit 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.061
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Change in CAT (COPD Assessment Test) during the course of treatment.

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    End point title
    		 Change in CAT (COPD Assessment Test) during the course of treatment.
    End point description
    Improvement of CAT (COPD assessment, sum of bronchial symptoms from 8 criteria).
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 11
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: CAT sum score
    arithmetic mean (standard deviation)
        Day 1
    23.6 ( 5.0 )
    22.7 ( 5.4 )
        Day 2
    22.0 ( 4.8 )
    21.8 ( 5.5 )
        Day 3
    20.4 ( 4.7 )
    20.6 ( 5.5 )
        Day 4
    18.9 ( 4.6 )
    19.5 ( 5.4 )
        Day 5
    17.4 ( 4.8 )
    18.2 ( 5.0 )
        Day 6
    16.3 ( 4.4 )
    17.2 ( 4.9 )
        Day 7
    15.3 ( 4.3 )
    16.1 ( 4.7 )
        Day 8
    14.0 ( 4.3 )
    14.9 ( 4.8 )
        Day 9
    13.2 ( 4.7 )
    13.6 ( 4.6 )
        Day 10
    12.0 ( 4.4 )
    13.5 ( 5.0 )
        Day 11
    13.1 ( 6.6 )
    12.3 ( 4.9 )
    Statistical analysis title
    		 CAT Day 1
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.075
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 2
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.835
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 3
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.711
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 4
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.154
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 5
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.061
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 6
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.06
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 7
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.087
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 8
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 9
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.217
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 10
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 CAT Day 11
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.896
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: SF-12 - Physical health

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    End point title
    		 SF-12 - Physical health
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 - Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Sum score
    arithmetic mean (standard deviation)
        Day 0
    41.2 ( 7.3 )
    40.4 ( 8.2 )
        Day 7
    44.2 ( 7.5 )
    43.1 ( 8.0 )
        Day 10
    48.0 ( 6.8 )
    47.1 ( 7.3 )
        Difference between day 0 and day 7
    2.1 ( 10.1 )
    2.5 ( 9.1 )
        Difference between day 0 and day 10
    5.9 ( 10.5 )
    6.4 ( 9.7 )
    Statistical analysis title
    		 SF12 Physical Day 0
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.29
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12 Physical Day 7
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.19
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12 Physical Day 10
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.272
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12 Physical Day 0-Day7
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.778
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12 Physical Day 0-Day10
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.934
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: SF12 - Mental health

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    End point title
    		 SF12 - Mental health
    End point description
    The SF-12 questionnaire was designed to detect group differences in the physical and mental health of the patients. These were not found.
    End point type
    Secondary
    End point timeframe
    Visit 1 - Visit 4
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    195
    189
    Units: Sum score
    arithmetic mean (standard deviation)
        Day 0
    46.3 ( 10 )
    47.7 ( 9.3 )
        Day 7
    46.5 ( 8.5 )
    45.8 ( 8.2 )
        Day 10
    48.1 ( 8.2 )
    47.3 ( 8.6 )
        Difference between day 0 and day 7
    -0.8 ( 11.7 )
    -2.2 ( 10.6 )
        Difference between day 0 and day 10
    0.8 ( 12.2 )
    -0.7 ( 11.1 )
    Statistical analysis title
    		 SF12- Mental health day
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.122
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12- Mental health day 7
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.404
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12- Mental health day 10
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.419
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SF12- Mental health day 0-day7
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.182
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Copy of SF12- Mental health day 0-day10
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.215
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator had to report all serious adverse events (SAEs) immediately, but no later than within 24 hours of becoming aware of them and submit a detailed written report (SAE report form)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Investigational product
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Investigational product Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 195 (0.00%)
    0 / 189 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Investigational product Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 195 (14.36%)
    17 / 189 (8.99%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 189 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 195 (5.13%)
    7 / 189 (3.70%)
         occurrences all number
    10
    7
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 189 (0.53%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    4 / 195 (2.05%)
    0 / 189 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 189 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Menstrual discomfort
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 189 (1.06%)
         occurrences all number
    0
    2
    Urinary infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 189 (0.53%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 189 (0.00%)
         occurrences all number
    1
    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 2018
    Editorial changes, specification of exclusion criteria, specification of documentation of immune-modulating and immune-suppressing medication
    10 May 2019
    Prolongation of study duration, change of deputy QPPV of CRO
    17 Oct 2019
    Prolongation of study duration
    24 Feb 2020
    Prolongation of study duration

    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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