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    Clinical Trial Results:
    Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.

    Summary
    EudraCT number
    		 2015-005155-27
    Trial protocol
    		 SI   HR  
    Global end of trial date
    06 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2020
    First version publication date
    04 Jun 2020
    Other versions
    Summary report(s)
    		 Final Report Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    KCT09/2015-SeptaNazal-Double
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Krka d.d., Novo mesto
    Sponsor organisation address
    Dunajska cesta 65, Ljubljana, Slovenia, 1000
    Public contact
    Tanja Kohek, Krka d.d., Novo mesto Dunajska cesta 65 1000 Ljubljana Slovenia, 00386 41589769, tanja.kohek@krka.biz
    Scientific contact
    Tanja Kohek, Krka d.d., Novo mesto Dunajska cesta 65 1000 Ljubljana Slovenia, 00386 41589769, tanja.kohek@krka.biz
    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
    31 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the double blind, randomized trial is to compare the efficacy of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, on nasal congestion and the healing effect of dexpanthenol in patients with acute rhinitis and in patients after surgery in the nose and paranasal cavity.
    Protection of trial subjects
    Patients were not included in the clinical study if they were hypersensitive to the active substances or to any of the excipients, if they had dry nasal inflammation, if they received local or systemic flu treatment, sympathomimetics or if they concomitantly received another nasal decongestant.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 17
    Country: Number of subjects enrolled
    Croatia: 177
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    194
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 There were 154 patients with acute rhinitis (Group 1) and 40 patients after an operation in the nose and paranasal cavities (Group 2) enrolled in the study.

    Pre-assignment
    Screening details
    		 In general, patients aged 18-60 years, with nasal occlusion after an operation in the nose and paranasal cavities or with acute rhinitis, were eligible for inclusion in the study. Eligible patients needed to tolerate intranasal administration of the IMP and sign informed consent form (ICF).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acute Rhinitis + Xylometazoline
    Arm description
    		 Patients with acute Rhinitis who were treated only with Xylometazoline. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasal spray with Xylometazoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Nasal spray with 0.1% Xylometazoline 3 times per day 1 spray in each nostril.

    Arm title
    		 Acute Rhinitis + Xylometazoline + Dexpanthenol
    Arm description
    		 Patients with acute Rhinitis who were treated with Xylometazoline and Dexpanthenol. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasal spray with Xylometazoline and Dexpanthenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Nasal spray with 0.1% Xylometazoline and 5% Dexpanthenol 3 times per day 1 spray in each nostril.

    Arm title
    		 Nose operation + Xylometazoline
    Arm description
    		 Patients after an operation in the nose and paranasal cavities who were treated only with Xylometazoline. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasal spray with Xylometazoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Nasal spray with 0.1% Xylometazoline 3 times per day 1 spray in each nostril.

    Arm title
    		 Nose operation + Xylometazoline + Dexpanthenol
    Arm description
    		 Patients after an operation in the nose and paranasal cavities who were treated with Xylometazoline and Dexpanthenol. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasal spray with Xylometazoline and Dexpanthenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Nasal spray with 0.1% Xylometazoline and 5% Dexpanthenol 3 times per day 1 spray in each nostril.

    Number of subjects in period 1
    		Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Started
    80
    74
    23
    17
    Completed
    79
    72
    23
    17
    Not completed
    1
    2
    0
    0
         Lost to follow-up
    1
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acute Rhinitis + Xylometazoline
    Reporting group description
    		 Patients with acute Rhinitis who were treated only with Xylometazoline. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Acute Rhinitis + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients with acute Rhinitis who were treated with Xylometazoline and Dexpanthenol. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated only with Xylometazoline. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated with Xylometazoline and Dexpanthenol. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.

    Reporting group values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol Total
    Number of subjects
    		 80 74 23 17 194
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    The age data is available for all patients with acute Rhinitis and for all patients after surgery in nose and paranasal cavities regardless of the IMP. Arithmetic mean of age of patients with acute Rhinitis (154) was 39.2 years (SD 11.78) and of patients after operation in nose and paranasal cavities (40) was 41.6 years (SD 11.03).
    Units: years
        arithmetic mean (standard deviation)
    		 39.2 ( 11.78 ) 39.2 ( 11.78 ) 41.6 ( 11.03 ) 41.6 ( 11.03 ) -
    Gender categorical
    For 2 patients in Arm 1 (Acute Rhinitis + Xylomethazoline), for 1 patient in Arm 3 (Nose operation + Xylomethazoline) and for 1 patient in Arm 4 (Nose operation + Xylomethazoline + Dexpanthenol) we do not have the data on the gender.
    Units: Subjects
        Female
    		 49 51 7 3 110
        Male
    		 29 23 15 13 80
        NA
    		 2 0 1 1 4

    End points

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    End points reporting groups
    Reporting group title
    Acute Rhinitis + Xylometazoline
    Reporting group description
    		 Patients with acute Rhinitis who were treated only with Xylometazoline. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Acute Rhinitis + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients with acute Rhinitis who were treated with Xylometazoline and Dexpanthenol. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated only with Xylometazoline. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated with Xylometazoline and Dexpanthenol. There were 40 patients altogether after an operation in the nose and paranasal cavities. 23 were treated only with Xylometazoline and 17 were treated with Xylometazoline and Dexpanthenol.

    Primary: Investigator`s assessment of nasal patency using anterior Rhinoscopy

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    End point title
    		 Investigator`s assessment of nasal patency using anterior Rhinoscopy
    End point description
    The primary objective was to compare the efficacy of nasal sprays of a fixed combination of xylometazoline and dexpanthenol (Septanazal®) and xylometazoline in the nasal congestion of patients with acute rhinitis and patients after operation in the nose and paranasal cavities. The researcher examined the right and left nasal cavities of all patients using anterior rhinoscopy and evaluated the degree of global patency in the nasal cavity determined by the VAS (Visual Analogue Scale) scale (0 - complete nasal patency, 10 - completely occluded nose). The examination was performed on Visit 1 (Day 1), Visit 2 (Day 3) and Visit 3 (Day 7). In all patients (treated with either Septanazal or xylometazoline), the patency in both nasal cavities improved during treatment, which is directly indicated by a decrease in nasal obstruction from the first to the last visit.
    End point type
    Primary
    End point timeframe
    7 days for one patient and was the same for the whole duration of the study.
    End point values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects analysed
    80
    74
    23
    17
    Units: mm on VAS
    arithmetic mean (standard deviation)
        Right nasal cavity Visit 1
    7.0 ( 1.4 )
    7.2 ( 1.6 )
    5.5 ( 2.3 )
    4.7 ( 2.2 )
        Left nasal cavity Visit 1
    7.0 ( 1.4 )
    6.9 ( 1.6 )
    5.6 ( 2.3 )
    3.9 ( 2.6 )
        Right nasal cavity Visit 2
    4.6 ( 1.4 )
    4.9 ( 1.5 )
    4.8 ( 2.5 )
    3.4 ( 1.5 )
        Left nasal cavity Visit 2
    4.7 ( 1.5 )
    4.8 ( 1.4 )
    4.9 ( 2.6 )
    2.6 ( 1.5 )
        Right nasal cavity Visit 3
    2.2 ( 1.4 )
    2.3 ( 1.5 )
    3.2 ( 2.8 )
    2.0 ( 1.5 )
        Left nasal cavity Visit 3
    2.1 ( 1.4 )
    2.1 ( 1.5 )
    3.5 ( 3.0 )
    2.0 ( 1.7 )
    Statistical analysis title
    		 Nasal patency across visits
    Statistical analysis description
    The efficacy of Septanazal and xylomethazoline in the reduction of nasal occlusion was compared between visits using asymptotic z-test. Both Septanazal and xylomethazoline expressed statistically significant reduction in nasal occlusion between visits 1 and 2, 2 and 3 as well as 1 and 3.
    Comparison groups
    Acute Rhinitis + Xylometazoline v Acute Rhinitis + Xylometazoline + Dexpanthenol v Nose operation + Xylometazoline v Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 asymptotic z-test
    Confidence interval

    Primary: Patient`s assessment of nasal patency

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    End point title
    		 Patient`s assessment of nasal patency
    End point description
    The primary objective was to compare the efficacy of nasal sprays of a fixed combination of xylometazoline and dexpanthenol (Septanazal®) and xylometazoline in the nasal congestion of patients with acute rhinitis and patients after operation in the nose and paranasal cavities. The patient also evaluated nasal patency using a VAS scale. Nasal patency was assessed before IMP administration and 1 minute, 3 minutes, 6 minutes and 9 minutes after IMP administration. Both Septanazal and xylometazoline effect was observed within 1 minute of administration. Even greater is the reduction of nasal occlusion after 3, 6 and 9 minutes after application of any IMP. There were no statistically significant differences between Septanazal and xylometazoline before and 1 minute, 3 minutes, 6 minutes and 9 minutes after IMP administration.
    End point type
    Primary
    End point timeframe
    7 days for one patient and was the same for the whole duration of the study.
    End point values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects analysed
    80
    74
    23
    17
    Units: mm on VAS
    arithmetic mean (standard deviation)
        Before IMP
    7.11 ( 1.75 )
    7.40 ( 1.55 )
    4.85 ( 2.59 )
    4.55 ( 2.22 )
        1 minute after IMP
    5.13 ( 1.82 )
    5.32 ( 2.07 )
    3.64 ( 2.04 )
    3.74 ( 2.35 )
        3 minutes after IMP
    3.84 ( 1.74 )
    4.15 ( 1.91 )
    3.42 ( 2.61 )
    2.94 ( 2.25 )
        6 minutes after IMP
    3.00 ( 1.79 )
    3.43 ( 1.90 )
    3.00 ( 2.40 )
    2.36 ( 1.99 )
        9 minutes after IMP
    2.48 ( 1.81 )
    2.89 ( 1.97 )
    2.82 ( 2.45 )
    1.99 ( 2.00 )
    Statistical analysis title
    		 Comparing efficacy of nasal sprays
    Statistical analysis description
    The efficacy of Septanazal and xylomethazoline in the reduction of nasal occlusion was compared with the statistical comparison of means of VAS reductions in patients treated with Septanazal and patients treated with xylomethazoline, using either the unpaired t-test or the Wilcoxon-Mann-Whitney test, if the assumptions for unpaired t-test were not met.
    Comparison groups
    Acute Rhinitis + Xylometazoline v Acute Rhinitis + Xylometazoline + Dexpanthenol v Nose operation + Xylometazoline v Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - In patients with acute Rhinitis (Group 1) all differences between Septanazal and xylomethazoline efficacy were statistically insignificant (before IMP P=0.28185, 1 min P=0.55145, 3 min P=0.29645, 6 min P=0.15029, 9 min P=0.17259). In patients with after nose surgery (Group 2) all differences between Septanazal and xylomethazoline efficacy were statistically insignificant (before IMP P=0.70127, 1 min P=0.88677, 3 min P=0.50163, 6 min P=0.36600, 9 min P=0.24734).

    Primary: Questionnaire SNOT-22 REV 2 - "Nose occlusion"

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    End point title
    		 Questionnaire SNOT-22 REV 2 - "Nose occlusion"
    End point description
    SNOT-22 REV 2 is a questionnaire used to evaluate acute inflammation of the nasal mucosa and chronic inflammation of the nasal mucosa and the paranasal cavities. Of the 22 questions asked, one was about "nose occlusion". The question was evaluated with points from 0 to 5, with the number representing the severity of the symptoms (0 - symptom no problem, 5 - symptom most severe). PATIENTS AFTER NOSE SURGERY: A statistically significant comparison of the average values of nasal occlusion was found at the 3rd visit, in favor of Septanazal and was 1.0, p=0.020. Comparison of differences in reduction of nasal occlusion from V1 to V3 between the two studied groups was statistically insignificant. PATIENTS WITH ACUTE RHINITIS: Average values of nasal occlusion on 1st and 3rd visit as well as comparison of differences in reduction of nasal occlusion from V1 to V3 between the two studied groups were statistically insignificant.
    End point type
    Primary
    End point timeframe
    7 days for one patient and was the same for the whole duration of the study.
    End point values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects analysed
    80
    74
    23
    17
    Units: points
    arithmetic mean (standard deviation)
        Visit 1 (Day 1)
    3.6 ( 0.91 )
    3.9 ( 0.87 )
    3.6 ( 1.24 )
    3.2 ( 1.13 )
        Visit 3 (Day 7)
    1.3 ( 0.93 )
    1.4 ( 1.17 )
    1.9 ( 1.35 )
    0.9 ( 1.12 )
    Statistical analysis title
    		 SNOT-22 REV 2 - Nose occlusion
    Comparison groups
    Acute Rhinitis + Xylometazoline v Acute Rhinitis + Xylometazoline + Dexpanthenol v Nose operation + Xylometazoline v Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Patient`s subjective assessment of obstructed breathing

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    End point title
    		 Patient`s subjective assessment of obstructed breathing
    End point description
    After the IMP application, the patient evaluated the severity of 11 symptoms on a scale from 0 to 4 (0 - symptom no problems, 4 - symptom very serious problems). One of the symptoms was the "sensation of obstructed breathing through the nose", which directly indicates nasal occlusion. The evaluation took place at all three visits. PATIENTS AFTER NOSE SURGERY: The observed symptom decreased statistically significantly from the V1 to the V3 (decrease by 41% in the xylometazoline group (p = 0.031) and 49% in the Septanazal group (p = 0.004)). PATIENTS WITH ACUTE RHINITIS: The observed symptom decreased statistically significantly from the V1 to the V3 (a decrease of 63% in the xylometazoline group (p <0.0001) and 64% in the Septanazal group (p <0.0001)).
    End point type
    Primary
    End point timeframe
    7 days for one patient and was the same for the whole duration of the study.
    End point values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects analysed
    80
    74
    23
    17
    Units: points
    arithmetic mean (standard deviation)
        Visit 1 (Day 1)
    2.2 ( 1.09 )
    2.4 ( 1.10 )
    2.0 ( 1.51 )
    1.4 ( 1.32 )
        Visit 2 (Day 3)
    1.5 ( 0.9 )
    1.8 ( 0.87 )
    1.6 ( 1.16 )
    1.1 ( 0.68 )
        Visit 3 (Day 7)
    0.8 ( 0.62 )
    0.9 ( 0.71 )
    1.2 ( 0.98 )
    0.7 ( 0.79 )
    Statistical analysis title
    		 Patient`s subjective assessment
    Comparison groups
    Acute Rhinitis + Xylometazoline v Acute Rhinitis + Xylometazoline + Dexpanthenol v Nose operation + Xylometazoline v Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Global assessment of individual`s behavior - GAIB

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    End point title
    		 Global assessment of individual`s behavior - GAIB
    End point description
    At V2 and V3, the investigator evaluated the improvement in signs and symptoms during treatment using GAIB. GAIB contains a 7-point rating (0 - fully improved, 6 - worse disease/condition than at baseline). GAIB compared the end state versus the severity of the initial condition. PATIENTS AFTER NOSE SURGERY: The mean score decreased from V2 to V3 for 0.38 (35%, P=0.0078) in the group treated with Septanazal and for 0.39 (25%, P=0.0019) in the group treated with xylometazoline. Comparison of mean global estimates of improvement did not show a statistically significant difference between the groups studied. PATIENTS WITH ACUTE RHINITIS: The mean score decreased from V2 to V3 for 0.96 (52%, P<0.0001) in the group treated with Septanazal and for 0.72 (47%, P<0.0001) in the group treated with xylometazoline. Comparison of mean global estimates of improvement showed a statistically significant difference between the groups only on V2 with Septanazal group having a higher score (p<0.027).
    End point type
    Primary
    End point timeframe
    7 days for one patient and was the same for the whole duration of the study.
    End point values
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects analysed
    80
    73
    23
    16
    Units: points
    arithmetic mean (standard deviation)
        Visit 2 (Day 3)
    1.53 ( 0.90 )
    1.84 ( 0.87 )
    1.57 ( 1.16 )
    1.06 ( 0.68 )
        Visit 3 (Day 7)
    0.81 ( 0.62 )
    0.88 ( 0.71 )
    1.17 ( 0.98 )
    0.69 ( 0.79 )
    Statistical analysis title
    		 Global assessment of individual`s behavior
    Comparison groups
    Acute Rhinitis + Xylometazoline v Acute Rhinitis + Xylometazoline + Dexpanthenol v Nose operation + Xylometazoline v Nose operation + Xylometazoline + Dexpanthenol
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE reporting for one patient was 7 days and was the same for the whole duration of the study (from the day the first patient entered (23.1.2017) to the day the last patient concluded the study (6.3.2018)).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Acute Rhinitis + Xylometazoline
    Reporting group description
    		 Patients with acute Rhinitis who were treated only with Xylometazoline. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Acute Rhinitis + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients with acute Rhinitis who were treated with Xylometazoline and Dexpanthenol. There were 154 patients altogether with acute Rhinitis. 80 were treated only with Xylometazoline and 74 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated only with Xylometazoline. There were 40 patients altogether after an operation in the nose and paranasal cavities. 24 were treated only with Xylometazoline and 16 were treated with Xylometazoline and Dexpanthenol.

    Reporting group title
    Nose operation + Xylometazoline + Dexpanthenol
    Reporting group description
    		 Patients after an operation in the nose and paranasal cavities who were treated with Xylometazoline and Dexpanthenol. There were 40 patients altogether after an operation in the nose and paranasal cavities. 24 were treated only with Xylometazoline and 16 were treated with Xylometazoline and Dexpanthenol.

    Serious adverse events
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 74 (0.00%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Acute Rhinitis + Xylometazoline Acute Rhinitis + Xylometazoline + Dexpanthenol Nose operation + Xylometazoline Nose operation + Xylometazoline + Dexpanthenol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 80 (5.00%)
    7 / 74 (9.46%)
    2 / 23 (8.70%)
    0 / 17 (0.00%)
    Vascular disorders
    Bleeding nose
         subjects affected / exposed
    2 / 80 (2.50%)
    5 / 74 (6.76%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 74 (0.00%)
    1 / 23 (4.35%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Head pressure
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 74 (0.00%)
    1 / 23 (4.35%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 74 (2.70%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    General disorders and administration site conditions
    Nasal burning
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 74 (4.05%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Bad taste
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 74 (0.00%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 74 (0.00%)
    1 / 23 (4.35%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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