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    Clinical Trial Results:
    A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects with Chronic Rhinoinusitis Without the Presence of Nasal Polyps

    Summary
    EudraCT number
    		 2019-000648-86
    Trial protocol
    		 GB   CZ   PL   ES   BG   RO  
    Global end of trial date
    04 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2023
    First version publication date
    25 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPN-FLU-CS-3206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 110089
    Sponsors
    Sponsor organisation name
    OptiNose US, Inc.
    Sponsor organisation address
    1020 Stony Hill Road, Suite 300, Yardley, PA, United States, 19067
    Public contact
    John Messina, Sr. VP Global Clinical Research and Medical Affairs, OptiNose US, Inc., john.messina@optinose.com
    Scientific contact
    John Messina, Sr. VP Global Clinical Research and Medical Affairs, OptiNose US, Inc., john.messina@optinose.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 μg of OPN-375 (fluticasone propionate) with placebo in subjects with chronic rhinosinusitis (CRS) using the following co-primary endpoints: • change from baseline in symptoms as measured by a composite score of nasal symptoms (CSNS): congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at the end of Week 4 and • change from baseline to Week 24/ET in the average percent of the opacified volume (APOV) in the ethmoid and maxillary sinuses
    Protection of trial subjects
    Subjects will be informed that they are free to withdraw from study treatment and/or the study at any time at their own request without prejudice to their future medical care, or that they may be withdrawn at any time at the discretion of the investigator or Sponsor for safety, nonadherence to protocol requirements, or administrative reasons (eg, termination of the study ty Sponsor). Subjects wishing to withdraw from study treatment will be strongly encouraged to continue in the study and have all scheduled study procedures performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2019
    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
    United States: 22
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Georgia: 23
    Country: Number of subjects enrolled
    Poland: 103
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    Czechia: 18
    Worldwide total number of subjects
    223
    EEA total number of subjects
    171
    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)
    196
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was carried out in subjects with chronic sinusitis without nasal polyps.

    Pre-assignment
    Screening details
    		 Subjects who met screening eligibility criteria at Visit 1 (Screening) entered a 7- to 21-day, singleblind, placebo, run-in period to ensure symptom eligibility criteria were met, and (if meeting symptom criteria) to have CT verification of eligibility.

    Pre-assignment period milestones
    Number of subjects started
    		 475 [1]
    Number of subjects completed
    		 222

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failed: 1
    Reason: Number of subjects
    		 Not eligible: 252
    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: 253 subjects failed the eligibility verification phase and were never enrolled into the study.
    Period 1
    Period 1 title
    Period 1 (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
    		 Placebo
    Arm description
    		 Placebo nasal spray, 1 or 2 sprays per nostril twice daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 or 2 sprays per nostril twice daily

    Arm title
    		 OPN-375 (186 μg BID)
    Arm description
    		 OPN-375 1 spray per nostril (186 μg) twice daily (BID). One subject was randomized in error (inadvertently registered as randomized; misrandomized) by the study site in the interactive web response system that was supposed to be “screen failed.” The error was recognized at the time of the misrandomization and the subject never received any investigational product and was therefore not treated. This subject is presented as "screen failed" in the preassignment period details and has not been included as part of the study results. This subject was not included in the baseline or any of the results tables.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPN-375
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray per nostril (186 μg per dose)

    Arm title
    		 OPN-375 (372 μg BID)
    Arm description
    		 OPN-375 2 sprays per nostril (372 μg) twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPN-375
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    2 sprays per nostril (372 μg per dose)

    Number of subjects in period 1 [2]
    		Placebo OPN-375 (186 μg BID) OPN-375 (372 μg BID)
    Started
    75
    73
    74
    Completed
    69
    70
    71
    Not completed
    6
    3
    3
         Consent withdrawn by subject
    1
    1
    1
         Adverse event, non-fatal
    2
    1
    1
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    2
    1
    -
         Protocol deviation
    -
    -
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was randomized in error (inadvertently registered as randomized; misrandomized) by the study site in the interactive web response system that was supposed to be “screen failed.” The error was recognized at the time of the misrandomization and the subject never received any investigational product. This subject is presented as "screen failed" in the preassignment period details and has not been included as part of the study results but is included in the worldwide number enrolled.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo nasal spray, 1 or 2 sprays per nostril twice daily

    Reporting group title
    OPN-375 (186 μg BID)
    Reporting group description
    		 OPN-375 1 spray per nostril (186 μg) twice daily (BID). One subject was randomized in error (inadvertently registered as randomized; misrandomized) by the study site in the interactive web response system that was supposed to be “screen failed.” The error was recognized at the time of the misrandomization and the subject never received any investigational product and was therefore not treated. This subject is presented as "screen failed" in the preassignment period details and has not been included as part of the study results. This subject was not included in the baseline or any of the results tables.

    Reporting group title
    OPN-375 (372 μg BID)
    Reporting group description
    		 OPN-375 2 sprays per nostril (372 μg) twice daily (BID)

    Reporting group values
    		 Placebo OPN-375 (186 μg BID) OPN-375 (372 μg BID) Total
    Number of subjects
    		 75 73 74 222
    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)
    		 67 62 66 195
        From 65-84 years
    		 8 11 8 27
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.7 ( 12.34 ) 47.1 ( 13.75 ) 49.4 ( 13.53 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 40 39 111
        Male
    		 43 33 35 111
    Race
    Units: Subjects
        White
    		 74 72 73 219
        Black or African American
    		 1 1 0 2
        Other
    		 0 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 2 0 3
        Not Hispanic or Latino
    		 74 71 74 219
    Previous or current diagnosis of nasal polyps
    Units: Subjects
        Yes
    		 16 9 18 43
        No
    		 59 64 56 179
    Diagnosed with aspirin esacerbated respiratory disease (AERD)
    Units: Subjects
        Yes
    		 2 1 0 3
        No
    		 73 72 74 219
    Diagnosed with environmental allergies
    Units: Subjects
        Yes
    		 23 24 22 69
        No
    		 52 49 52 153
    Currently receiving immunotherapy for environmental allergies (denominator = subjects diagnosed with
    Currently receiving immunotherapy for environmental allergies (denominator = subjects diagnosed with environmental allergies) Not applicable = subjects not diagnosed with environmental allergies
    Units: Subjects
        Yes
    		 1 3 2 6
        No
    		 24 23 21 68
        Not applicable
    		 50 47 51 148
    Number of acute exacerbations of chronic sinusitis with an antibiotic or oral steriod last year
    Units: Subjects
        0 acute sinusitis exacerbations
    		 34 36 34 104
        1 acute sinusitis exacerbations
    		 20 17 19 56
        2 acute sinusitis exacerbations
    		 11 10 10 31
        3 acute sinusitis exacerbations
    		 5 5 6 16
        4 acute sinusitis exacerbations
    		 3 1 3 7
        5 acute sinusitis exacerbations
    		 1 4 1 6
        6 acute sinusitis exacerbations
    		 0 0 1 1
        7 acute sinusitis exacerbations
    		 0 0 0 0
        8 acute sinusitis exacerbations
    		 1 0 0 1
    Prior Sinus Surgery (Subgroups for Analyses in the Full Analysis Set)
    Prior Sinus Surgery only counts any ethmoidectomy or maxillary antrostomy.
    Units: Subjects
        Yes
    		 27 25 26 78
        No
    		 48 47 47 142
        Not applicable
    		 0 1 1 2
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 77.90 ( 16.860 ) 75.66 ( 14.935 ) 82.07 ( 20.451 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo nasal spray, 1 or 2 sprays per nostril twice daily

    Reporting group title
    OPN-375 (186 μg BID)
    Reporting group description
    		 OPN-375 1 spray per nostril (186 μg) twice daily (BID). One subject was randomized in error (inadvertently registered as randomized; misrandomized) by the study site in the interactive web response system that was supposed to be “screen failed.” The error was recognized at the time of the misrandomization and the subject never received any investigational product and was therefore not treated. This subject is presented as "screen failed" in the preassignment period details and has not been included as part of the study results. This subject was not included in the baseline or any of the results tables.

    Reporting group title
    OPN-375 (372 μg BID)
    Reporting group description
    		 OPN-375 2 sprays per nostril (372 μg) twice daily (BID)

    Primary: Change from Baseline to Week 4 in the 7-Day Average of Instantaneous Morning Composite Symptom Score

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    End point title
    		 Change from Baseline to Week 4 in the 7-Day Average of Instantaneous Morning Composite Symptom Score
    End point description
    Change from baseline to the end of Week 4 in average total instantaneous morning (AM) scores (evaluation of symptom severity immediately preceding the time of scoring in the morning) of a composite symptom score (CSS): nasal congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior). LS = least squares CSS = composite symptom score -9999/9999= not applicable
    End point type
    Primary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo OPN-375 (186 μg BID) OPN-375 (372 μg BID)
    Number of subjects analysed
    72
    72
    71
    Units: LS mean change from baseline in CSS
    least squares mean (confidence interval 95%)
        LS Mean Change (from baseline)
    -0.81 (-9999 to 9999)
    -1.54 (-9999 to 9999)
    -1.74 (-9999 to 9999)
        LS Mean Difference (active minus placebo)
    9999 (-9999 to 9999)
    -0.73 (-1.29 to -0.17)
    -0.93 (-1.49 to -0.37)
    Statistical analysis title
    		 OPN-375 (186 μg BID) versus Placebo
    Comparison groups
    OPN-375 (186 μg BID) v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 OPN-375 (372 μg BID) versus Placebo
    Comparison groups
    Placebo v OPN-375 (372 μg BID)
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: Change from Baseline to Week 24/early termination in average of the percentages of opacified volume in Ethmoid and Maxillary Sinuses Combined

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    End point title
    		 Change from Baseline to Week 24/early termination in average of the percentages of opacified volume in Ethmoid and Maxillary Sinuses Combined
    End point description
    Change from Baseline to Week 24/early termination in average of the percentages of opacified volume in Ethmoid and Maxillary Sinuses Combined (Full Analysis Set – Primary Estimand) LS = least squares -9999/9999 = not applicable
    End point type
    Primary
    End point timeframe
    Baseline to Week 24 or early termination
    End point values
    		 Placebo OPN-375 (186 μg BID) OPN-375 (372 μg BID)
    Number of subjects analysed
    66
    70
    69
    Units: LS mean change from baseline
    least squares mean (confidence interval 95%)
        LS Mean Change (from baseline)
    1.19 (-9999 to 9999)
    -7.00 (-9999 to 9999)
    -5.14 (-9999 to 9999)
        LS Mean Difference (active minus placebo)
    9999 (-9999 to 9999)
    -8.19 (-12.93 to -3.45)
    -6.33 (-11.08 to -1.58)
    Statistical analysis title
    		 OPN-375 (186 μg BID) versus placebo
    Comparison groups
    Placebo v OPN-375 (186 μg BID)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 OPN-375 (372 μg BID) versus placebo
    Comparison groups
    Placebo v OPN-375 (372 μg BID)
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    .Period of observation for collection of AEs extended from time the subject gave informed consent until completion of the double-blind treatment period or an early termination visit. Serious AEs were reported through 30 days after
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo nasal spray, 1 or 2 sprays per nostril twice daily

    Reporting group title
    OPN-375 186 μg
    Reporting group description
    		 OPN-375 1 spray per nostril (186 μg) twice daily (BID). Adverse events are provided for the safety analysis set.

    Reporting group title
    OPN-375 372 μg
    Reporting group description
    		 OPN-375 2 sprays per nostril (372 μg) twice daily (BID)

    Serious adverse events
    		 Placebo OPN-375 186 μg OPN-375 372 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    4 / 74 (5.41%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo OPN-375 186 μg OPN-375 372 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 75 (41.33%)
    24 / 73 (32.88%)
    43 / 74 (58.11%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    3
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 75 (0.00%)
    4 / 73 (5.48%)
    7 / 74 (9.46%)
         occurrences all number
    0
    4
    16
    Asthma
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    4
    0
    2
    Cough
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    2
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    1
    0
    1
    Rhinalgia
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal mucosal erosion
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal polyps
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    4
    0
    0
    Nasal septum ulceration
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    3 / 74 (4.05%)
         occurrences all number
    1
    0
    3
    Insomnia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    1
    Anxiety
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Joint injury
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination complication
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    Congenital, familial and genetic disorders
    Block vertebra
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Chronic coronary syndrome
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 75 (8.00%)
    2 / 73 (2.74%)
    7 / 74 (9.46%)
         occurrences all number
    8
    2
    11
    Sinus headache
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    Anosmia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Migraine
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Cataract cortical
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    1
    0
    1
    Cataract nuclear
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    2
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Eye allergy
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Madarosis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    Arthralgia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    1
    0
    1
    Back pain
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    2
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    1
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 73 (4.11%)
    7 / 74 (9.46%)
         occurrences all number
    2
    3
    7
    Nasopharyngitis
         subjects affected / exposed
    5 / 75 (6.67%)
    3 / 73 (4.11%)
    4 / 74 (5.41%)
         occurrences all number
    6
    3
    5
    Chronic sinusitis
         subjects affected / exposed
    5 / 75 (6.67%)
    1 / 73 (1.37%)
    3 / 74 (4.05%)
         occurrences all number
    5
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 73 (2.74%)
    1 / 74 (1.35%)
         occurrences all number
    2
    2
    1
    Influenza
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 73 (2.74%)
    0 / 74 (0.00%)
         occurrences all number
    0
    3
    0
    Sinusitis
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    8
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    Acute sinusitis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    Lyme disease
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngopharyngitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jul 2020
    Amendment 1: Added a biomarker substudy; modified inclusion/exclusion criteria; added “cobicistat” to examples of CYP3A4 inhibitors; modified the protocol in reaction to the Coronavirus Disease 2019 (COVID-19) pandemic; changed physical examination at screening from full to brief; clarified that urine pregnancy test was required at each visit; revised an endpoint related to sinus volume occupied by disease from evaluating “each” maxillary and ethmoid sinus occupied by disease to evaluating the “worst” maxillary and “worst” ethmoid sinus; added an assessment of the impact of treatment on subjects approved for surgery who no longer elect to undergo surgery; limited ocular assessments to visual acuity, cataract assessment, and IOP assessment (later removed for pandemic reasons); and removed receipt of systemic corticosteroids (oral or parenteral) as a reason for withdrawing a subject from the study.
    28 Aug 2020
    Amendment 2: Removed ocular assessments; removed “Early Termination (ET)” from objectives and endpoints; modified exclusion criteria; updated statistical analyses; clarified concomitant medication vs rescue medications.
    15 Oct 2021
    Amendment 3: Modified key secondary and other secondary objectives/endpoints by moving SF36v2 MCS and PCS endpoints from key secondary to other secondary; added key secondary objectives/endpoints to be analyzed using pooled data from Studies 3205 and 3206; added “Early Termination (ET)” back to the objectives and endpoints; and updated sample size based on results from an IA of Study 3205.

    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.
    Not applicable.
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