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    Clinical Trial Results:
    ELABORATION OF A PATIENT-FRIENDLY TREATMENT STRATEGY WITH CAPSAICIN NASAL SPRAY IN PATIENTS WITH IDIOPATHIC RHINITIS

    Summary
    EudraCT number
    		 2014-003914-10
    Trial protocol
    		 BE  
    Global end of trial date
    31 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2021
    First version publication date
    07 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    sept2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02288156
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    UZ Leuven, UZ Leuven, Leen.cools@uzleuven.be
    Scientific contact
    UZ Leuven, UZ Leuven, leen.cools@uzleuven.be
    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
    01 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if the two novel treatment modalities show non-inferiority compared to the current treatment modality of capsaicin nasal treatment in 120 patients with IR. The gathered data of this single center trial can be used to guide the decision on the set-up and the design of a larger multi-center trial being powered to prove non-inferiority.
    Protection of trial subjects
    On the application day, the nasal mucosa was anesthetized before the first 2 applications by application of a cocaine 5% nasal spray. To ensure effective local anesthesia, an interval of 15 minutes was maintained between the application of the cocaine and the blinded nasal spray.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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
    Belgium: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in Belgium from 2015 till 2018.

    Pre-assignment
    Screening details
    		 Main inclusion criteria: •Idiopathic rhinitis (IR) patients with at least 1 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day, •IR patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS). •Age > 18 and < 60 years.

    Period 1
    Period 1 title
    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
    		 0,1mM Capsaïcin / Placebo
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Capsaicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Patient is treated with 0,1mM capsaicin, 5 applications on 1 day at 1-hour intervals. per application: 2 puffs in each nostril, 0.4mL/puff. 4 weeks thereafter, the patient is treated daily with placebo

    Arm title
    		 Placebo / 0,01mM Capsaicin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Patient is treated with placebo, 5 applications on 1 day at 1-hour intervals. per application: 2 puffs in each nostril, 0.4mL/puff. 4 weeks thereafter, the patient is treated daily with 0,01mM Capsaicin

    Arm title
    		 Placebo / 0,001mM Capsaicin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Patient is treated with placebo, 5 applications on 1 day at 1-hour intervals. per application: 2 puffs in each nostril, 0.4mL/puff. 4 weeks thereafter, the patient is treated daily with 0,001mM Capsaicin

    Arm title
    		 Placebo / Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Patient is treated with placebo, 5 applications on 1 day at 1-hour intervals. per application: 2 puffs in each nostril, 0.4mL/puff. 4 weeks thereafter, the patient is treated daily with placebo

    Number of subjects in period 1
    		0,1mM Capsaïcin / Placebo Placebo / 0,01mM Capsaicin Placebo / 0,001mM Capsaicin Placebo / Placebo
    Started
    20
    20
    20
    20
    Completed
    16
    16
    18
    18
    Not completed
    4
    4
    2
    2
         Lost to follow-up
    2
    3
    2
    1
         Protocol deviation
    2
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    0,1mM Capsaïcin / Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,01mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,001mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / Placebo
    Reporting group description
    		 -

    Reporting group values
    		 0,1mM Capsaïcin / Placebo Placebo / 0,01mM Capsaicin Placebo / 0,001mM Capsaicin Placebo / Placebo Total
    Number of subjects
    		 20 20 20 20 80
    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
    Units: years
        arithmetic mean (standard deviation)
    		 50 ( 14 ) 45 ( 10 ) 48 ( 14 ) 45 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 10 11 41
        Male
    		 9 11 10 9 39

    End points

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    End points reporting groups
    Reporting group title
    0,1mM Capsaïcin / Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,01mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,001mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / Placebo
    Reporting group description
    		 -

    Primary: VAS major nasal symptom at week 4

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    End point title
    		 VAS major nasal symptom at week 4
    End point description
    Comparison of VAS for major nasal symptom at week 4 in all treatments modalities. The region of equivalence of the compared treatment modalities is defined as a difference in VAS of less than 1.
    End point type
    Primary
    End point timeframe
    Week 4 after treatment
    End point values
    		 0,1mM Capsaïcin / Placebo Placebo / 0,01mM Capsaicin Placebo / 0,001mM Capsaicin Placebo / Placebo
    Number of subjects analysed
    16
    16
    18
    18
    Units: VAS score
        arithmetic mean (standard deviation)
    3.66 ( 2.78 )
    4.29 ( 2.92 )
    4.49 ( 2.93 )
    5.6 ( 1.67 )
    Statistical analysis title
    		 Compairison of VAS values between different groups
    Statistical analysis description
    The VAS major nasal symptom was compared at 4 weeks post treatment between the dfferent treatment groups
    Comparison groups
    0,1mM Capsaïcin / Placebo v Placebo / 0,01mM Capsaicin v Placebo / 0,001mM Capsaicin v Placebo / Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing informed consent till end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    0,1mM Capsaïcin / Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,01mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / 0,001mM Capsaicin
    Reporting group description
    		 -

    Reporting group title
    Placebo / Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 0,1mM Capsaïcin / Placebo Placebo / 0,01mM Capsaicin Placebo / 0,001mM Capsaicin Placebo / Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 0,1mM Capsaïcin / Placebo Placebo / 0,01mM Capsaicin Placebo / 0,001mM Capsaicin Placebo / Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 16 (62.50%)
    8 / 16 (50.00%)
    14 / 18 (77.78%)
    12 / 18 (66.67%)
    Surgical and medical procedures
    Eyelid operation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Head discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    2
    Loss of consciousness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Mite allergy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    1
    Nasal congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
         occurrences all number
    0
    3
    1
    1
    Nasal crusting
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Sneezing
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Throat clearing
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    3
    1
    Laryngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 16 (43.75%)
    5 / 16 (31.25%)
    8 / 18 (44.44%)
    6 / 18 (33.33%)
         occurrences all number
    11
    9
    9
    9
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
         occurrences all number
    2
    0
    5
    2
    Tonsillitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    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
    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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