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    Clinical Trial Results:
    Prospective, controlled, randomized double-blind study to determine the sensory perception of two nasal sprays using the model of treatment of post-operative complaints after surgery on the nasal mucosa.

    Summary
    EudraCT number
    		 2019-004936-52
    Trial protocol
    		 DE  
    Global end of trial date
    04 Dec 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CASK0119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassella-med GmbH & Co KG
    Sponsor organisation address
    Gereonsmühlengasse 1, Cologne, Germany, 50670
    Public contact
    Clinical Operations, Cassella-med GmbH & Co. KG, +49 8001652200, dialog@cassella-med.eu
    Scientific contact
    Clinical Operations, Cassella-med GmbH & Co. KG, clinical.operations@klosterfrau.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to assess the sensory quality of the nasic neo nasal spray compared to a comparative preparation with the same active ingredient composition. It is assumed that the modified galenics due to the addition of hyaluronic acid improves the sensory quality of the nasal spray.
    Protection of trial subjects
    Physical examinations were carried out at screening visit. Only patients presented normal physical examination were included into the study. During the course of study for all patients the use of non-steroidal analgesics was allowed. Patients had the right to withdraw from the trial at any time and this irrespective of the reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2020
    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: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    51
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 After the patients have undergone surgery on the nasal mucosa by medical members of the study group, they were informed about the study and were given the Patient Information Form. After having given written informed consent, the patients were examined for suitability according to the inclusion and exclusion criteria.

    Pre-assignment
    Screening details
    		 Subjects were eligible for inclusion, if the main criteria were met: - post-operative nasal breathing disabilities after surgery on the nasal septum or the nasal conchae - surgical intervention must have taken place at least one week prior to enrolment - signed and dated Informed Consent

    Period 1
    Period 1 title
    Treatment Sequence 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This clinical trial was performed as a randomised, double-blind, controlled study in a crossover design. The treatment kits with the treatment sequence corresponding to the randomisation list were delivered with the sealed emergency envelopes. No person involved in the conduct or evaluation of the study did know the treatment sequence of the individual patients.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Period 1 - IMP
    Arm description
    		 When randomized to treatment sequence 1, the IMP Nasic Neo was given to the patients at the first visit (V1) at the trial site.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasic Neo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    At the first visit at the trial site, the patients were given nasal spray Nasic Neo when randomized to treatment sequence 1. The initial applicated dose was one spray shot per nostril. The patients applied the nasal spray independently at home (one spray shot per nostril, maximum three times a day).

    Arm title
    		 Period 2 - Comparator
    Arm description
    		 When randomized to treatment sequence 1, the comparator NasenDuo was given after wash-out at visit 3 to the patients at the trial site.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NasenDuo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    After wash-out, the patients were given nasal spray NasenDuo at visit 3 when randomized to treatment sequence 1. The initial applicated dose was one spray shot per nostril. The patients applied the nasal spray independently at home (one spray shot per nostril, maximum three times a day).

    Number of subjects in period 1
    		Period 1 - IMP Period 2 - Comparator
    Started
    26
    25
    Completed
    26
    25
    Period 2
    Period 2 title
    Treatment Sequence 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This clinical trial was performed as a randomised, double-blind, controlled study in a crossover design. The treatment kits with the treatment sequence corresponding to the randomisation list were delivered with the sealed emergency envelopes. No person involved in the conduct or evaluation of the study did know the treatment sequence of the individual patients.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Period 1 - Comparator
    Arm description
    		 When randomized to treatment sequence 2, the comparator NasenDuo was given at visit 1 to the patients at the trial site.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NasenDuo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    At the first visit at the trial site, the patients were given nasal spray NasenDuo when randomized to treatment sequence 2. The initial applicated dose was one spray shot per nostril. The patients applied the nasal spray independently at home (one spray shot per nostril, maximum three times a day).

    Arm title
    		 Period 2 - IMP
    Arm description
    		 When randomized to treatment sequence 2, the IMP Nasic Neo was given after wash-out at visit 3 to the patients at the trial site.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nasic Neo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    After wash-out, the patients were given nasal spray Nasic Neo at visit 3 when randomized to treatment sequence 2. The initial applicated dose was one spray shot per nostril. The patient applied the nasal spray independently at home (one spray shot per nostril, maximum three times a day).

    Number of subjects in period 2
    		Period 1 - Comparator Period 2 - IMP
    Started
    25
    26
    Completed
    23
    26
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: For the comparison of the inter- and intra-group changes in the sensory evaluation, the baseline values at V1 and V3 were assessed. This applies to Treatment Sequence 1 and also to Treatment Sequence 2, resulting overall in 51 subjects who attended the baseline period.
    Reporting group values
    		 Treatment Sequence 1 Total
    Number of subjects
    		 26 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 26 26
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Intergroup comparison - Treatment sequence 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inter-group comparison for the sum score of the sensoric assessment, ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intergroup comparison - Treatment sequence 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inter-group comparison for the sum score of the sensoric assessment, ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intragroup comparison - Treatment sequence 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intra-group comparison for further clinical effects- ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intragroup comparison - Treatment sequence 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intra-group comparison for further clinical effects- ΔV1-V2 vs. ΔV3-V4

    Subject analysis sets values
    		 Intergroup comparison - Treatment sequence 1 Intergroup comparison - Treatment sequence 2 Intragroup comparison - Treatment sequence 1 Intragroup comparison - Treatment sequence 2
    Number of subjects
    26
    23
    26
    23
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    26
    23
    26
    23
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    9
    10
    9
    10
        Male
    17
    13
    17
    13

    End points

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    End points reporting groups
    Reporting group title
    Period 1 - IMP
    Reporting group description
    		 When randomized to treatment sequence 1, the IMP Nasic Neo was given to the patients at the first visit (V1) at the trial site.

    Reporting group title
    Period 2 - Comparator
    Reporting group description
    		 When randomized to treatment sequence 1, the comparator NasenDuo was given after wash-out at visit 3 to the patients at the trial site.
    Reporting group title
    Period 1 - Comparator
    Reporting group description
    		 When randomized to treatment sequence 2, the comparator NasenDuo was given at visit 1 to the patients at the trial site.

    Reporting group title
    Period 2 - IMP
    Reporting group description
    		 When randomized to treatment sequence 2, the IMP Nasic Neo was given after wash-out at visit 3 to the patients at the trial site.

    Subject analysis set title
    Intergroup comparison - Treatment sequence 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inter-group comparison for the sum score of the sensoric assessment, ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intergroup comparison - Treatment sequence 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inter-group comparison for the sum score of the sensoric assessment, ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intragroup comparison - Treatment sequence 1
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intra-group comparison for further clinical effects- ΔV1-V2 vs. ΔV3-V4

    Subject analysis set title
    Intragroup comparison - Treatment sequence 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intra-group comparison for further clinical effects- ΔV1-V2 vs. ΔV3-V4

    Primary: Primary efficacy - sum scores of the assessments of the 14 items NSSS - inter group comparison

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    End point title
    		 Primary efficacy - sum scores of the assessments of the 14 items NSSS - inter group comparison
    End point description
    The primary endpoint of the study was the difference in the total-score of the sensory-assessments from the Nasal-Spray-Sensoric-Scale (14 items) between IMP and the comparative preparation after first application. The differences between the 2 nasal sprays were analysed independently of each other in the cross-over design in the assessments at V1 und V3 at the respective first application of the nasal sprays (inter-group-differences).
    End point type
    Primary
    End point timeframe
    Visit 1 to visit 4
    End point values
    		 Intergroup comparison - Treatment sequence 1 Intergroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: other
    arithmetic mean (standard deviation)
        V1: NSSS
    1172.38 ( 147.215 )
    1123.78 ( 199.424 )
        V2: NSSS
    1102.27 ( 222.836 )
    1078.48 ( 214.222 )
        V3: NSSS
    1230.69 ( 149.01 )
    1217.57 ( 162.76 )
        V4: NSSS
    1146.77 ( 265.751 )
    1145.26 ( 198.816 )
    Statistical analysis title
    		 Descriptive analysis for primary endpoint
    Statistical analysis description
    The analysis of the data of the primary end point was conducted using descriptive statistics.
    Comparison groups
    Intergroup comparison - Treatment sequence 1 v Intergroup comparison - Treatment sequence 2
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.487
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - The inter-group-differences of the sum scores in both treatment sequences showed a numerical superiority for the IMP.

    Secondary: Assessment of the sensory quality of nasal sprays, NSSS - intra group comparison

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    End point title
    		 Assessment of the sensory quality of nasal sprays, NSSS - intra group comparison
    End point description
    The comparison of intra-group changes in the sum score of the sensory evaluation from the Nasal Spray Sensory Scale over the course of treatment (ΔV1-V2 vs. ΔV3-V4).
    End point type
    Secondary
    End point timeframe
    Visit 1 to visit 4
    End point values
    		 Intragroup comparison - Treatment sequence 1 Intragroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: other
    arithmetic mean (standard deviation)
        Sensory quality - ΔV1-V2
    -2.35 ( 14.762 )
    -5.96 ( 24.08 )
        Sensory quality - ΔV3-V4
    5.69 ( 19.857 )
    -2.61 ( 30.449 )
    No statistical analyses for this end point

    Secondary: Assessment of the sensory quality of nasal sprays, Rhinoscopy score - inter group comparison

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    End point title
    		 Assessment of the sensory quality of nasal sprays, Rhinoscopy score - inter group comparison
    End point description
    The comparison of the inter-group differences in the individual sensory queries of the Nasal Spray Sensory Scale at V1 and V3 at the respective first use of the nasal sprays.
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 4
    End point values
    		 Intergroup comparison - Treatment sequence 1 Intergroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: other
    arithmetic mean (standard deviation)
        Rhinoscopy score - ΔV1-V2
    0.69 ( 1.569 )
    1.22 ( 1.347 )
        Rhinoscopy score - ΔV3-V4
    1.19 ( 1.96 )
    0.91 ( 2.151 )
    No statistical analyses for this end point

    Secondary: Further clinical effects, nasal obstruction, VAS - intra group comparison

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    End point title
    		 Further clinical effects, nasal obstruction, VAS - intra group comparison
    End point description
    The clinical effects of using the two nasal sprays were assessed by the change in nasal obstruction on a visual analogue scale (VAS) between V1 and V2, V1 and V3 and between V3 and V4.
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 4
    End point values
    		 Intragroup comparison - Treatment sequence 1 Intragroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: other
    arithmetic mean (standard deviation)
        VAS - ΔV1-V2
    5.5385 ( 24.02038 )
    4.6957 ( 29.08988 )
        VAS - ΔV3-V4
    5.7692 ( 23.70031 )
    16.2609 ( 37.5139 )
        VAS - ΔV1-V3
    12.92 ( 28.53 )
    -12.913 ( 36.55 )
    Statistical analysis title
    		 Nasal obstruction on VAS, difference V1 - V3
    Statistical analysis description
    Nasal obstruction significantly improved from first to second treatment period after treatment with the IMP demonstrating an advantage of the IMP over the comparative product.
    Comparison groups
    Intragroup comparison - Treatment sequence 2 v Intragroup comparison - Treatment sequence 1
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Individual sensory score - Estimation of the nasal moisturization

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    End point title
    		 Individual sensory score - Estimation of the nasal moisturization
    End point description
    The 10th item of the NSSS “Estimation of the nasal moisturization” was analysed separately for the first and the second period for the treatment with the IMP and the comparative product, respectively.
    End point type
    Secondary
    End point timeframe
    Visit 1 to visit 4
    End point values
    		 Intragroup comparison - Treatment sequence 1 Intragroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: other
    arithmetic mean (standard deviation)
        ΔV1-V3
    -4.12 ( 20.95 )
    -0.74 ( 25.80 )
        ΔV1-V2
    -4.50 ( 24.28 )
    0.78 ( 25.07 )
        ΔV3-V4
    -1.85 ( 21.91 )
    -8.96 ( 20.39 )
    Statistical analysis title
    		 Nasal moisturization, difference V3-V4
    Statistical analysis description
    The improvement of nasal moisturization during period 2 (V3-V4) was significant after treatment with the IMP.
    Comparison groups
    Intragroup comparison - Treatment sequence 1 v Intragroup comparison - Treatment sequence 2
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Final efficacy evaluation

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    End point title
    		 Final efficacy evaluation
    End point description
    Patients' assessment of overall efficacy of the two nasal sprays considering 4 evaluation points.
    End point type
    Secondary
    End point timeframe
    Day 0 - 3 and day 7 - 10.
    End point values
    		 Period 1 - IMP Period 1 - Comparator Period 2 - Comparator Period 2 - IMP
    Number of subjects analysed
    26
    25
    25
    26
    Units: numbers
        very good
    7
    3
    8
    10
        good
    16
    14
    11
    10
        satisfactory
    2
    6
    4
    3
        non satisfactory
    1
    1
    1
    3
        no answer
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Overall tolerability

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    End point title
    		 Overall tolerability
    End point description
    Patients' assessment of overall tolerability of the two nasal sprays considering 4 evaluation points.
    End point type
    Secondary
    End point timeframe
    Day 0 - 3 and day 7 - 10
    End point values
    		 Period 1 - IMP Period 1 - Comparator Period 2 - Comparator Period 2 - IMP
    Number of subjects analysed
    26
    25
    25
    26
    Units: numbers
        very good
    13
    9
    12
    14
        good
    12
    10
    9
    7
        satisfactory
    1
    4
    2
    4
        non satisfactory
    0
    0
    0
    1
        no answer
    0
    2
    2
    0
    No statistical analyses for this end point

    Secondary: Overall preference

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    End point title
    		 Overall preference
    End point description
    At V4 (day 10) or at the early termination follow up visit, patients were asked to indicate a preference of one of the two nasal sprays.
    End point type
    Secondary
    End point timeframe
    Day 0-3 and day 7-10
    End point values
    		 Intragroup comparison - Treatment sequence 1 Intragroup comparison - Treatment sequence 2
    Number of subjects analysed
    26
    23
    Units: numbers
        Nasal spray on day 0-3
    11
    6
        Nasal spray on day 7-10
    11
    17
        none of the nasal sprays
    4
    0
    Statistical analysis title
    		 Overall preference
    Statistical analysis description
    At V4 or at the early termination follow up visit, patients were asked to indicate a preference of one of the two nasal sprays. The results show a significant advantage of the IMP over the comparative product.
    Comparison groups
    Intragroup comparison - Treatment sequence 1 v Intragroup comparison - Treatment sequence 2
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within time frame of drug administration (V1 through V4)
    Adverse event reporting additional description
    Any adverse event experienced by a subject to whom one of the tested products had been administered, which was not necessarily causally related to that treatment was defined as adverse event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Full safety set
    Reporting group description
    		 -

    Serious adverse events
    		 Full safety set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Full safety set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 51 (9.80%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    8
    General disorders and administration site conditions
    Local reaction
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 51 (3.92%)
         occurrences all number
    8
    Rhinalgia
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    8
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    8
    Otitis media
         subjects affected / exposed
    1 / 51 (1.96%)
         occurrences all number
    8

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34689304
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