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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo and active controlled parallel-group trial to assess the efficacy and safety of the fixed combination medicinal product Mometasone furoate + Azelastine hydrochloride nasal spray (50 + 140 mcg) in the treatment of seasonal allergic rhinitis

    Summary
    EudraCT number
    		 2021-004050-31
    Trial protocol
    		 DE   BG   PL  
    Global end of trial date
    20 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2024
    First version publication date
    05 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAN-0677
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05590598
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CRO code number: CLK21001
    Sponsors
    Sponsor organisation name
    Lek Pharmaceuticals d.d.
    Sponsor organisation address
    Verovškova ulica 57, Ljubljana, Slovenia,
    Public contact
    Group Head Clinical Development, Lek Pharmaceuticals d.d., +386 15802800, aleksander.bajc@sandoz.com
    Scientific contact
    Group Head Clinical Development, Lek Pharmaceuticals d.d., +386 15802800, aleksander.bajc@sandoz.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003122-PIP01-21
    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
    13 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the present trial is to show the benefit of the treatment on nasal symptoms in patients with seasonal allergic rhinitis with the fixed combination medicinal product (test; MomAze nasal spray) Mometasone + Azelastine nasal spray (50 mcg / 140 mcg per actuation) in comparison to the treatment with the individual medicinal products Mometasone furoate nasal spray (50 mcg per actuation) and Azelastine hydrochloride nasal spray (140 mcg per actuation) (comparators; Mometasone, Azelastine).
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2022
    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
    Poland: 69
    Country: Number of subjects enrolled
    Bulgaria: 261
    Country: Number of subjects enrolled
    Germany: 89
    Country: Number of subjects enrolled
    Moldova, Republic of: 249
    Worldwide total number of subjects
    668
    EEA total number of subjects
    419
    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)
    64
    Adults (18-64 years)
    603
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 1184 [1]
    Number of subjects completed
    		 668

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 498
    Reason: Number of subjects
    		 Consent withdrawn by subject: 9
    Reason: Number of subjects
    		 Pregnancy: 3
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Reason: Number of subjects
    		 Lost to Follow-up: 1
    Reason: Number of subjects
    		 Non-compliance: 1
    Reason: Number of subjects
    		 Refused treatment: 1
    Reason: Number of subjects
    		 Physician decision: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: They were screening failures, so not all subjects included in pre-assignment period were enrolled in the trial.
    Period 1
    Period 1 title
    Treatment period (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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone + Azelastine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone + Azelastine (50 + 140 mcg per actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Dosage: 50 mcg mometasone furoate and 140 mcg azelastine hydrochloride per actuation 1 actuation in each nostril in the morning and 1 actuation in each nostril in the evening for 14 days

    Arm title
    		 Mometasone furoate nasal spray
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone furoate nasal spray (50 mcg per actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Dosage: 50 mcg mometasone furoate per actuation 1 actuation in each nostril in the morning and 1 actuation in each nostril in the evening for 14 days

    Arm title
    		 Azelastine hydrochloride nasal spray
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azelastine hydrochloride nasal spray (140 mcg per actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Dosage: 140 mcg azelastine hydrochloride per actuation 1 actuation in each nostril in the morning and 1 actuation in each nostril in the evening for 14 days

    Arm title
    		 Placebo nasal spray
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    1 actuation in each nostril mornings and evenings for 14 days

    Number of subjects in period 1
    		Mometasone + Azelastine Mometasone furoate nasal spray Azelastine hydrochloride nasal spray Placebo nasal spray
    Started
    194
    189
    187
    98
    Completed
    192
    187
    184
    96
    Not completed
    2
    2
    3
    2
         Consent withdrawn by subject
    2
    1
    -
    -
         Physician decision
    -
    -
    -
    2
         Adverse event, non-fatal
    -
    1
    2
    -
         Refused
    -
    -
    1
    -

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 668 668
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 64 64
        Adults (18-64 years)
    		 603 603
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.3 ± 12.8 -
    Gender categorical
    Units: Subjects
        Female
    		 341 341
        Male
    		 327 327
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of the trial medication.

    Subject analysis set title
    Full-Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of the trial medication and who have at least one post-baseline assessment of TNSS during the double-blind treatment period.

    Subject analysis sets values
    		 Safety Set Full-Analysis Set
    Number of subjects
    668
    666
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    64
        Adults (18-64 years)
    603
        From 65-84 years
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.3 ± 12.8
    ±
    Gender categorical
    Units: Subjects
        Female
    341
        Male
    327

    End points

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    End points reporting groups
    Reporting group title
    Mometasone + Azelastine
    Reporting group description
    		 -

    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 -

    Reporting group title
    Azelastine hydrochloride nasal spray
    Reporting group description
    		 -

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 -

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of the trial medication.

    Subject analysis set title
    Full-Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of the trial medication and who have at least one post-baseline assessment of TNSS during the double-blind treatment period.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    End point type
    Primary
    End point timeframe
    First 7 days of treatment.
    End point values
    		 Mometasone + Azelastine Mometasone furoate nasal spray Azelastine hydrochloride nasal spray Placebo nasal spray Full-Analysis Set
    Number of subjects analysed
    194
    188
    187
    97
    666
    Units: Total Nasal Symptom Score (TNSS)
    194
    188
    187
    97
    666
    Statistical analysis title
    		 Test vs Comparator 1
    Statistical analysis description
    Change from baseline in mean TNSS over 7 days treatment period.
    Comparison groups
    Mometasone + Azelastine v Mometasone furoate nasal spray
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2247
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Test vs Comparator 2
    Comparison groups
    Mometasone + Azelastine v Azelastine hydrochloride nasal spray
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1139
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Test vs Placebo
    Comparison groups
    Mometasone + Azelastine v Placebo nasal spray
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0179
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Comparator 1 vs Placebo
    Comparison groups
    Mometasone furoate nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Comparator 2 vs Placebo
    Comparison groups
    Azelastine hydrochloride nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2877
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization until the last study visit (day 16 (+1))
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Mometasone + Azelastine
    Reporting group description
    		 -

    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 -

    Reporting group title
    Azelastine hydrochloride nasal spray
    Reporting group description
    		 -

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 -

    Serious adverse events
    		 Mometasone + Azelastine Mometasone furoate nasal spray Azelastine hydrochloride nasal spray Placebo nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Intermenstrual bleeding
    Additional description: Metrorrhagia due to medication abortion
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Mometasone + Azelastine Mometasone furoate nasal spray Azelastine hydrochloride nasal spray Placebo nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 194 (7.22%)
    8 / 189 (4.23%)
    8 / 187 (4.28%)
    6 / 98 (6.12%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    1
    0
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Human chorionic gonadotropin increased
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Product use complaint
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wound haemorrhage
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    4 / 194 (2.06%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    5
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    2 / 194 (1.03%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Administration site wound
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Asthenia
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 194 (0.52%)
    1 / 189 (0.53%)
    2 / 187 (1.07%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    2
    2
    Nasal crusting
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Rhinalgia
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Asthma
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased upper airway secretion
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal dryness
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus allergic
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    0
    0
    1
    Solar dermatitis
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    1 / 98 (1.02%)
         occurrences all number
    0
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 189 (0.53%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 189 (0.00%)
    0 / 187 (0.00%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    1 / 187 (0.53%)
    0 / 98 (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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    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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