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    Clinical Trial Results:
    MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY ON THE THERAPEUTIC EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE SUSPENSION FOR INHALATION 800 micrograms TWICE DAILY VS PLACEBO ADDED TO ANTIBIOTIC THERAPY IN PATIENTS WITH ACUTE RHINOSINUSITIS

    Summary
    EudraCT number
    		 2011-001459-35
    Trial protocol
    		 IT  
    Global end of trial date
    27 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MC/PR/1400/007/11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01691677
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chiesi Farmaceutici Spa
    Sponsor organisation address
    Via Palermo 26/A, Parma, Italy, 43122
    Public contact
    CTT Manager, Chiesi Farmaceutici, clinicaltrials_info@chiesi.com
    Scientific contact
    CTT Manager, Chiesi Farmaceutici, clinicaltrials_info@chiesi.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
    27 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that BDP suspension for inhalation twice a day for 14 days added to antibiotic therapy improves clinical success rate and accelerates recovery in patients with acute rhinosinusitis.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements . Other than routine care, no specific measures for protection of trial subjects were implemented.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 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
    Italy: 166
    Worldwide total number of subjects
    166
    EEA total number of subjects
    166
    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)
    164
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 166 patients were randomised to receive the assigned treatment: 83 were assigned to the nebulised BDP group and 83 were assigned to the Placebo group. Nine patients, 2 (2.4% of randomised) in the BDP group and 7 (8.4%) in the Placebo group, discontinued the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The realization of the double blind design was made it possible by the use of a BDP suspension for nebulization placebo UDV, which was totally indistinguishable from the respective active in terms of size, shape, colour and mode of inhalation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test treatment
    Arm description
    		 Beclomethasone dipropionate (BDP) suspension for nebulization (Clenil per Aerosol, Chiesi Farmaceutici S.p.A.) 800 μg/2 mL one administration b.i.d. for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP
    Investigational medicinal product code
    Other name
    beclomethasone dipropionate
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Beclomethasone dipropionate (BDP) suspension for nebulization (Clenil per Aerosol, Chiesi Farmaceutici S.p.A.) 800 μg/2 mL one administration b.i.d. for 14 days.

    Arm title
    		 Reference treatment
    Arm description
    		 Matched BDP placebo solution for nebulisation, 2 ml one administration b.i.d. for 14 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Matched BDP placebo solution for nebulisation, 2 ml one administration b.i.d. for 14 days

    Number of subjects in period 1
    		Test treatment Reference treatment
    Started
    83
    83
    Completed
    81
    76
    Not completed
    2
    7
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    5
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test treatment
    Reporting group description
    		 Beclomethasone dipropionate (BDP) suspension for nebulization (Clenil per Aerosol, Chiesi Farmaceutici S.p.A.) 800 μg/2 mL one administration b.i.d. for 14 days.

    Reporting group title
    Reference treatment
    Reporting group description
    		 Matched BDP placebo solution for nebulisation, 2 ml one administration b.i.d. for 14 days

    Reporting group values
    		 Test treatment Reference treatment Total
    Number of subjects
    		 83 83 166
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 82 82 164
        From 65-84 years
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 0 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 46 54 100
        Male
    		 37 29 66
    Subject analysis sets

    Subject analysis set title
    BDP - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who took at least one dose of study medication.

    Subject analysis set title
    Placebo - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who took at least one dose of study medication.

    Subject analysis set title
    BDP - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients with post-baseline data and completing at least the first week of treatment (i.e. attending visit 2).

    Subject analysis set title
    Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients with post-baseline data and completing at least the first week of treatment (i.e. attending visit 2).

    Subject analysis sets values
    		 BDP - safety population Placebo - safety population BDP - ITT population Placebo - ITT population
    Number of subjects
    82
    78
    81
    77
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    81
    77
    80
    76
        From 65-84 years
    1
    1
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.84 ± 11.67
    40.56 ± 12.62
    39.89 ± 11.74
    40.38 ± 12.6
    Gender categorical
    Units: Subjects
        Female
    45
    51
    44
    50
        Male
    37
    27
    37
    27

    End points

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    End points reporting groups
    Reporting group title
    Test treatment
    Reporting group description
    		 Beclomethasone dipropionate (BDP) suspension for nebulization (Clenil per Aerosol, Chiesi Farmaceutici S.p.A.) 800 μg/2 mL one administration b.i.d. for 14 days.

    Reporting group title
    Reference treatment
    Reporting group description
    		 Matched BDP placebo solution for nebulisation, 2 ml one administration b.i.d. for 14 days

    Subject analysis set title
    BDP - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who took at least one dose of study medication.

    Subject analysis set title
    Placebo - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who took at least one dose of study medication.

    Subject analysis set title
    BDP - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients with post-baseline data and completing at least the first week of treatment (i.e. attending visit 2).

    Subject analysis set title
    Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients with post-baseline data and completing at least the first week of treatment (i.e. attending visit 2).

    Primary: Clinical success at Day 7

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    End point title
    		 Clinical success at Day 7
    End point description
    Clinical success is defined as a patient report of cured or much improved throughout the treatment period or the untreated follow-up period.
    End point type
    Primary
    End point timeframe
    The overall sinus symptoms were assessed through patient reports at Day 7 (Visit 2), at Day 14 (Visit 3) during the tratment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase.
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    30
    24
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.437
    Method
    		 Chi-squared
    Confidence interval

    Primary: Clinical success at Day 14

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    End point title
    		 Clinical success at Day 14
    End point description
    Clinical success is defined as a patient report of cured or much improved throughout the treatment period or the untreated follow-up period.
    End point type
    Primary
    End point timeframe
    The overall sinus symptoms were measured through patient reports at Day 7 (Visit 2), at Day 14 (Visit 3) during the tratment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase.
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    49
    47
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.944
    Method
    		 Chi-squared
    Confidence interval

    Primary: Clinical success at Day 21

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    End point title
    		 Clinical success at Day 21
    End point description
    Clinical success is defined as a patient report of cured or much improved throughout the treatment period or the untreated follow-up period
    End point type
    Primary
    End point timeframe
    The overall sinus symptoms were measured through patient reports at Day 7 (Visit 2), at Day 14 (Visit 3) during the tratment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase.
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    55
    53
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    Placebo - ITT population v BDP - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 Chi-squared
    Confidence interval

    Primary: Clinical success at Day 28

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    End point title
    		 Clinical success at Day 28
    End point description
    Clinical success is defined as a patient report of cured or much improved throughout the treatment period or the untreated follow-up period.
    End point type
    Primary
    End point timeframe
    The overall sinus symptoms were measured through patient reports at Day 7 (Visit 2), at Day 14 (Visit 3) during the tratment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase.
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    58
    55
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Time from baseline to a status of clinical success

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    End point title
    		 Time from baseline to a status of clinical success
    End point description
    End point type
    Secondary
    End point timeframe
    The overall sinus symptoms were evaluated at Day 7 (Visit 2), at Day 14 (Visit 3) during the tratment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: days
        median (confidence interval 95%)
    12 (11 to 15)
    14 (11 to 19)
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Cox regression analysis
    Point estimate
    0.986
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.682
         upper limit
    		 1.426

    Secondary: Change from baseline to Visit 2 in overall sinus symptoms

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    End point title
    		 Change from baseline to Visit 2 in overall sinus symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    The overall sinus symptoms were evaluated by the investigator at Day 7 (Visit 2), at Day 14 (Visit 3) during the treatment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    69
    Units: digit
        arithmetic mean (standard deviation)
    -3.2 ± 2.5
    -2.7 ± 2.1
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1214
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.5658
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2837
         upper limit
    		 0.152

    Secondary: Change from baseline to Visit 3 in overall sinus symptoms

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    End point title
    		 Change from baseline to Visit 3 in overall sinus symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    The overall sinus symptoms were evaluated by the investigator at Day 7 (Visit 2), at Day 14 (Visit 3) during the treatment phase, and at Day 21 (Visit 4) and at Day 28 (Visit 5) during the phone follow-up phase
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    69
    Units: digit
        arithmetic mean (standard deviation)
    -4.4 ± 3.2
    -4.8 ± 2.6
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6216
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.1961
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5878
         upper limit
    		 0.98

    Secondary: Change from baseline to Visit 2 in headache sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in headache sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    70
    Units: score
        arithmetic mean (standard deviation)
    -2.7 ± 2.5
    -2.6 ± 2.6
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6579
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.1612
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8793
         upper limit
    		 0.5569

    Secondary: Change from baseline to Visit 3 in headache sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in headache sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    68
    Units: score
        arithmetic mean (standard deviation)
    -3.6 ± 3.4
    -4.1 ± 3.1
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3107
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.3845
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3626
         upper limit
    		 1.1315

    Secondary: Change from baseline to Visit 2 in facial pain sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in facial pain sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    69
    Units: score
        arithmetic mean (standard deviation)
    -2.1 ± 2.3
    -2.3 ± 2.3
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7927
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.08783
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5718
         upper limit
    		 0.7474

    Secondary: Change from baseline to Visit 3 in facial pain sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in facial pain sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    67
    68
    Units: score
        arithmetic mean (standard deviation)
    -3 ± 3
    -3.6 ± 3
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1184
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.5349
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1383
         upper limit
    		 1.2082

    Secondary: Change from baseline to Visit 2 in facial pressure sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in facial pressure sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    70
    Units: score
        arithmetic mean (standard deviation)
    -2.1 ± 2.4
    -2.4 ± 2.4
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7298
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.1169
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5509
         upper limit
    		 0.7846

    Secondary: Change from baseline to Visit 3 in facial pressure sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in facial pressure sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    68
    Units: score
        arithmetic mean (standard deviation)
    -3.1 ± 3
    -3.8 ± 3.1
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2933
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.3695
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3232
         upper limit
    		 1.0621

    Secondary: Change from baseline to Visit 2 in nasal congestion sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in nasal congestion sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    70
    Units: score
        arithmetic mean (standard deviation)
    -3.6 ± 2.8
    -3 ± 2.4
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1355
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.5964
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3818
         upper limit
    		 0.189

    Secondary: Change from baseline to Visit 3 in nasal congestion sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in nasal congestion sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    69
    Units: score
        arithmetic mean (standard deviation)
    -4.8 ± 3.3
    -4.9 ± 2.7
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8481
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.07905
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7358
         upper limit
    		 0.8939

    Secondary: Change from baseline to Visit 2 in nasal discharge sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in nasal discharge sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    69
    Units: score
        arithmetic mean (standard deviation)
    -2.9 ± 2.9
    -2.6 ± 2.7
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2808
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.4263
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2049
         upper limit
    		 0.3523

    Secondary: Change from baseline to Visit 3 in nasal discharge sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in nasal discharge sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    68
    69
    Units: score
        arithmetic mean (standard deviation)
    -4.2 ± 3.9
    -4.4 ± 3
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7968
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.09944
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8617
         upper limit
    		 0.6629

    Secondary: Change from baseline to Visit 2 in olfactory disturbance sinus symptom

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    End point title
    		 Change from baseline to Visit 2 in olfactory disturbance sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    69
    69
    Units: score
        arithmetic mean (standard deviation)
    -2.6 ± 3
    -2.2 ± 2.4
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2263
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.4385
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1518
         upper limit
    		 0.2749

    Secondary: Change from baseline to Visit 3 in olfactory disturbance sinus symptom

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    End point title
    		 Change from baseline to Visit 3 in olfactory disturbance sinus symptom
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    67
    67
    Units: score
        arithmetic mean (standard deviation)
    -3.6 ± 3.7
    -3.5 ± 3.2
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8414
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    0.07302
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6472
         upper limit
    		 0.7933

    Secondary: Change from baseline ti Visit 2 in the level of work performance

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    End point title
    		 Change from baseline ti Visit 2 in the level of work performance
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    During treatment phase: at Visit 2 and Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    57
    56
    Units: score
        arithmetic mean (standard deviation)
    15.3 ± 32.2
    17.3 ± 30.8
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9887
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.063
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8704
         upper limit
    		 8.7444

    Secondary: Change from baseline to Visit 3 in the level of work performance

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    End point title
    		 Change from baseline to Visit 3 in the level of work performance
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    56
    56
    Units: score
        arithmetic mean (standard deviation)
    16.5 ± 43
    24 ± 39.5
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2696
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -6.165
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.1752
         upper limit
    		 4.8454

    Secondary: Missed working time over the study

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    End point title
    		 Missed working time over the study
    End point description
    This parameter was assessed using a VAS
    End point type
    Secondary
    End point timeframe
    From visit 1 to visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: days
        arithmetic mean (standard deviation)
    0.967 ± 2.037
    0.915 ± 1.762
    No statistical analyses for this end point

    Secondary: Absence of relapses over the study

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    End point title
    		 Absence of relapses over the study
    End point description
    End point type
    Secondary
    End point timeframe
    Over the study
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    80
    74
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.358
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Number of relapses

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    End point title
    		 Number of relapses
    End point description
    Relapse was observed in 2 (2.6%) patients in the Placebo group at Day 7, in 1 (1.3%) patient in the Placebo group at Day 14 and at Day 21, and in 1 patient in either group (1.2% in the BDP group and 1.3% in the Placebo group) at Day 28. One patient (1.2%) in the BDP group and 3 (3.9%) in the Placebo group had at least one relapse during the study.
    End point type
    Secondary
    End point timeframe
    Through overall trial
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    81
    77
    Units: number of subject
    1
    3
    No statistical analyses for this end point

    Secondary: Change from baseline to visit 2 in the level of nasal mucociliary transport time

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    End point title
    		 Change from baseline to visit 2 in the level of nasal mucociliary transport time
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    26
    28
    Units: min
        arithmetic mean (standard deviation)
    -3.96 ± 6.69
    -2.35 ± 4.74
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1898
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -1.1454
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8757
         upper limit
    		 0.5849

    Secondary: Change from baseline to Visit 3 in the level of nasal mucociliary transport time

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    End point title
    		 Change from baseline to Visit 3 in the level of nasal mucociliary transport time
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    25
    28
    Units: min
        arithmetic mean (standard deviation)
    -5.16 ± 6.66
    -3.69 ± 5.29
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2658
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.9266
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5687
         upper limit
    		 0.7234

    Secondary: Change from baseline to Visit 2 in total inspiratory nasal resistance

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    End point title
    		 Change from baseline to Visit 2 in total inspiratory nasal resistance
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    12
    13
    Units: Pa/mL/s
        arithmetic mean (standard deviation)
    -0.18 ± 0.1
    -0.11 ± 0.12
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1142
    Method
    		 ANOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.06933
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1567
         upper limit
    		 0.01808

    Secondary: Change from baseline to Visit 3 in total inspiratory nasal resistance

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    End point title
    		 Change from baseline to Visit 3 in total inspiratory nasal resistance
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    11
    13
    Units: Pa/mL/s
        arithmetic mean (standard deviation)
    -0.27 ± 0.12
    -0.22 ± 0.16
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2033
    Method
    		 ANOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.05455
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1409
         upper limit
    		 0.03182

    Secondary: Change from baseline to Visit 2 in total expiratory nasal resistance

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    End point title
    		 Change from baseline to Visit 2 in total expiratory nasal resistance
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    12
    13
    Units: Pa/mL/s
        arithmetic mean (standard deviation)
    -0.15 ± 0.1
    -0.1 ± 0.1
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1599
    Method
    		 ANOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.05759
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1397
         upper limit
    		 0.02452

    Secondary: Change from baseline to Visit 3 in total expiratory nasal resistance

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    End point title
    		 Change from baseline to Visit 3 in total expiratory nasal resistance
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - ITT population Placebo - ITT population
    Number of subjects analysed
    11
    13
    Units: Pa/mL/s
        arithmetic mean (standard deviation)
    -0.27 ± 0.14
    -0.2 ± 0.17
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1523
    Method
    		 ANOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.0668
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1603
         upper limit
    		 0.02672

    Secondary: Change from baseline in heart rate at Visit 2

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    End point title
    		 Change from baseline in heart rate at Visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    72
    68
    Units: bmp
        arithmetic mean (standard deviation)
    -0.4 ± 5.3
    0 ± 4
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - safety population v Placebo - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8062
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.1831
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6558
         upper limit
    		 1.2896

    Secondary: Change from baseline in heart rate at Visit 3

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    End point title
    		 Change from baseline in heart rate at Visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    72
    68
    Units: bpm
        arithmetic mean (standard deviation)
    -0.3 ± 5.6
    0.3 ± 4.4
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - safety population v Placebo - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6721
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.3246
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8374
         upper limit
    		 1.1883

    Secondary: Change from baseline in SBP at Visit 2

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    End point title
    		 Change from baseline in SBP at Visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    71
    69
    Units: mmHg
        arithmetic mean (standard deviation)
    -0.1 ± 7.1
    -0.1 ± 7.8
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - safety population v Placebo - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3174
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    1.181
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1462
         upper limit
    		 3.5082

    Secondary: Change from baseline in SBP at Visit 3

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    End point title
    		 Change from baseline in SBP at Visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    71
    69
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.5 ± 8.4
    0.3 ± 7.1
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - safety population v Placebo - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2063
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -1.4817
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7889
         upper limit
    		 0.8255

    Secondary: Change from baseline in DBP at Visit 2

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    End point title
    		 Change from baseline in DBP at Visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 2
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    71
    69
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.4 ± 5.7
    -0.3 ± 5.6
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    BDP - safety population v Placebo - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4927
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.6137
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3781
         upper limit
    		 1.1507

    Secondary: Change from baseline in DBP at Visit 3

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    End point title
    		 Change from baseline in DBP at Visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    The assessment was performed during treatment phase, at Visit 3
    End point values
    		 BDP - safety population Placebo - safety population
    Number of subjects analysed
    71
    69
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.5 ± 6
    -0.4 ± 5.8
    Statistical analysis title
    		 BDP vs placebo
    Comparison groups
    Placebo - safety population v BDP - safety population
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6112
    Method
    		 ANCOVA
    Parameter type
    		 adjusted mean difference
    Point estimate
    -0.4685
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2871
         upper limit
    		 1.35

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Visit 1 (Day 0, screening-baseline), Visit 2 (Day 7), Visit 3 (Day 14) during the treatment phase, and Visit 4 (Day 21) and Visit 5 (Day 28) during the phone follow-up phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Test treatment
    Reporting group description
    		 Beclomethasone dipropionate (BDP) suspension for nebulization (Clenil per Aerosol, Chiesi Farmaceutici S.p.A.) 800 μg/2 mL one administration b.i.d. for 14 days.

    Reporting group title
    Reference treatment
    Reporting group description
    		 Matched BDP placebo solution for nebulisation, 2 ml one administration b.i.d. for 14 days

    Serious adverse events
    		 Test treatment Reference treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 78 (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: 1%
    Non-serious adverse events
    		 Test treatment Reference treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 82 (6.10%)
    4 / 78 (5.13%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 78 (2.56%)
         occurrences all number
    6
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    4
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    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.
    No limitations or caveats are applicable to this summary.
    For support, Contact us.
    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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