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    Clinical Trial Results:
    A 16-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 µg of Fluticasone Propionate Twice a Day (bid) Using a Novel Bi-directional Device in Subjects with Bilateral Nasal Polyposis Followed by an 8-week Open-label Extension Phase to Assess Safety

    Summary
    EudraCT number
    		 2011-004886-34
    Trial protocol
    		 CZ   GB  
    Global end of trial date
    01 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2022
    First version publication date
    10 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OPN-FLU-NP-3101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01622569
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OptiNose US, Inc
    Sponsor organisation address
    1010 Stony Hill Road, Suite 300, Yardley, United States, PA 19067
    Public contact
    Jennifer Carothers, Vice President Global Clinical Operations & Outsourcing, OptiNose US, Inc, +1 267 364-3500, jennifer.carothers@optinose.com
    Scientific contact
    Jennifer Carothers, Vice President Global Clinical Operations & Outsourcing, OptiNose US, Inc, +1 267 364-3500, jennifer.carothers@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
    29 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2015
    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 100, 200, and 400 µg of OPN-375 twice a day (bid) delivered by the OptiNose device with matching placebo in subjects with bilateral nasal polyposis and nasal congestion. Two co-primary endpoints were used in the study: 1) reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7-day average instantaneous morning diary symptom scores (ADS7-IA), and 2) reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of the double-blind treatment phase as determined by a nasal polyp grading scale score measured by nasoendoscopy. Explanatory note about age range: age ranges for data collection in this study were 18-65 years and >/= 65 years. There were no patients in the age range of >/= 65 years.
    Protection of trial subjects
    This clinical study was conducted in compliance with the protocol, ethical principles that have their origin in the Declaration of Helsinki in its revised edition, the guidelines of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) (CPMP/ICH/135/95), European Union (EU) Clinical Trials Directive 2001/20/EC, EU Commission Directive 2005/28/EC, applicable US FDA Regulations, and with local laws and regulations in any country of conduct.
    Background therapy
    		 - Acetaminophen and NSAIDs were permitted for analgesia; aspirin was permitted for cardiovascular prophylaxis. Aspirin and NSAIDs were not allowed for subjects with a documented sensitivity to these medications. - Antibiotic medications were permitted (except for those prohibited below) for bacterial infections that developed during the study. Subjects, who were taking prophylactic antibiotics, were allowed to enter the study as long as they intended to continue the antibiotics for the duration of the study. - Intranasal saline spray was permitted with the exception that it could not be used within 2 hours before or after study drug administration. - Saline lavage was permitted only for those subjects regularly using it before study entry; subjects could not initiate use during the study, and could not change usage during the study. Saline lavage was not performed within 2 hours before or after study drug administration. - Stable doses of leukotriene receptor antagonists, beta-blockers, and neuroleptics. - Low-to medium-strength topical corticosteroids for dermatologic purposes. - Other concomitant medications were allowed, if not specifically listed as prohibited. In subjects with comorbid asthma or COPD at study entry (ie, Visit 1 [screening]), inhaled corticosteroid use was limited to stable doses of no more than 1000 µg/day of beclomethasone (or equivalent). Subjects had to be on a stable dose for least 3 months prior to Visit 1 (screening) with plans to continue use throughout the study. Use of rescue medication was not allowed during the single-blind run-in or before the Week 4 visit of the double-blind treatment phase. Subjects were allowed to use OTC loratadine 10 mg per day or another country-available, nonsedating antihistamine (eg, cetirizine, levocetirizine, desloratadine) at the label-recommended, usual dose per day as rescue medication following the Week 4 visit in the double-blind treatment phase and throughout the open-label-extension phase
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2013
    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
    Canada: 18
    Country: Number of subjects enrolled
    Ukraine: 65
    Country: Number of subjects enrolled
    United States: 143
    Country: Number of subjects enrolled
    South Africa: 30
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Czech Republic: 56
    Worldwide total number of subjects
    323
    EEA total number of subjects
    67
    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)
    323
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 539 subjects were screened, 456 subjects entered the single-blind run-in phase, and a total of 323 subjects were subsequently enrolled and randomized (ITT Population) at 54 study centers in the double-blind phase.

    Pre-assignment
    Screening details
    		 Assessments included nasoendoscopy-related procedures (nasal examination, nasoendoscopy, and surgical intervention assessment), ocular examinations, clinical laboratory tests, physical examination, and confirmation of ability to use the OptiNose drug delivery system. Subjects also completed a medical evaluation questionnaire.

    Pre-assignment period milestones
    Number of subjects started
    		 456 [1]
    Number of subjects completed
    		 323

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 133
    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: The 456 subjects who entered the pretreatment phase administered morning and evening doses of placebo and completed a daily e-diary immediately prior to morning and evening doses. Instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the previous 12 hours) scores for nasal symptoms were recorded. At the end of the pretreatment phase only eligible subjects entered into the double-blind treatment phase.
    Period 1
    Period 1 title
    Double-blind Treatment Phase (Wks 1-16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    During the double-blind treatment phase of the study, subjects, the investigator, study personnel at each center, and the sponsor or its designated personnel directly involved in the clinical study remained blinded to study treatment. The investigator was not provided with the randomization code. The randomization codes were maintained within the IVRS/IWRS, which allowed the investigator to break the blind for an individual subject, if needed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo BID x 16 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    At Visit 2, Day 1 (baseline), subjects received 2 study drug kits. At subsequent visits every 4 weeks through Week 12, subjects received a single study drug kit. Each study drug kit consisted of 2 OPN-375 drug delivery units, 1 marked “1” and another marked “2.” Both contained placebo. For the morning and evening doses, subjects administered a single spray from the device marked 1 to both the right and left nostrils followed by a single spray from the device marked 2 to both the right and left nostrils. Subjects in the placebo group received 2 sprays containing placebo.

    Arm title
    		 OPN-375 100 μg
    Arm description
    		 OPN-375 100 μg BID x 16 weeks,
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPTINOSE FLUTICASONE
    Investigational medicinal product code
    OPN-375
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    At Visit 2, Day 1 (baseline), subjects received 2 study drug kits. At subsequent visits every 4 weeks through Week 12, subjects received a single study drug kit. Each study drug kit consisted of 2 OPN-375 drug delivery units, 1 marked “1” and another marked “2.” Subjects in the 100 µg group received 2 units that dispensed 25 µg fluticasone propionate per actuation. For the morning and evening doses, subjects administered a single spray from the device marked 1 to both the right and left nostrils followed by a single spray from the device marked 2 to both the right and left nostrils. In this way, subjects in all groups received an equal number of sprays: subjects in the 100 µg group received 4 sprays of 25 µg each

    Arm title
    		 OPN-375 200 μg
    Arm description
    		 OPN-375 200 μg BID x 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPTINOSE FLUTICASONE
    Investigational medicinal product code
    OPN-375
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    At Visit 2, Day 1 (baseline), subjects received 2 study drug kits. At subsequent visits every 4 weeks through Week 12, subjects received a single study drug kit. Each study drug kit consisted of 2 OPN-375 drug delivery units, 1 marked “1” and another marked “2.”Subjects in the 200 µg group received 1 unit that dispensed placebo and 1 unit that dispensed 100 µg fluticasone propionate per actuation. For the morning and evening doses, subjects administered a single spray from the device marked 1 to both the right and left nostrils followed by a single spray from the device marked 2 to both the right and left nostrils. In this way, subjects in all groups received an equal number of sprays: subjects in the 200 µg group received 2 sprays containing placebo and 2 sprays containing 100 µg each.

    Arm title
    		 OPN-375 400 μg
    Arm description
    		 OPN-375 400 μg BID x 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPTINOSE FLUTICASONE
    Investigational medicinal product code
    OPN-375
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    At Visit 2, Day 1 (baseline), subjects received 2 study drug kits. At subsequent visits every 4 weeks through Week 12, subjects received a single study drug kit. Each study drug kit consisted of 2 OPN-375 drug delivery units, 1 marked “1” and another marked “2.” Subjects in the 400 µg group received 2 units, each dispensing 100 µg fluticasone propionate per actuation. For the morning and evening doses, subjects administered a single spray from the device marked 1 to both the right and left nostrils followed by a single spray from the device marked 2 to both the right and left nostrils. In this way, subjects in all groups received an equal number of sprays: subjects in the 400 µg group received 4 sprays of 100µg each

    Number of subjects in period 1
    		Placebo OPN-375 100 μg OPN-375 200 μg OPN-375 400 μg
    Started
    82
    81
    80
    80
    Completed
    70
    75
    71
    76
    Not completed
    12
    6
    9
    4
         Consent withdrawn by subject
    2
    2
    2
    -
         Adverse event, non-fatal
    4
    2
    3
    1
         Lost to follow-up
    -
    -
    1
    -
         Lack of efficacy
    6
    -
    3
    2
         Protocol deviation
    -
    2
    -
    1
    Period 2
    Period 2 title
    Open-Label Extension Phase (Wks 17-24)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    During the open-label treatment extension phase, all individuals involved in the study were aware that the treatment was open-label with OPN-375 400 µg bid, but remained unaware of which treatment had been received during the prior 16 weeks.

    Arms
    Arm title
    		 OPN-375 400 μg - open label
    Arm description
    		 OPN-375 400 μg (open-label) BID x 8 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    OPTINOSE FLUTICASONE
    Investigational medicinal product code
    OPN-375
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the Week 16 visit, subjects received 2 study drug kits. One kit was used during Weeks 17 to 20 and the other kit was used during Weeks 21 to 24. During the open-label extension phase, all subjects received OPN-375 400 µg bid.

    Number of subjects in period 2 [2]
    		OPN-375 400 μg - open label
    Started
    282
    Completed
    274
    Not completed
    8
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    3
         Lack of efficacy
    4
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 31 patients did not complete the previous double-blind treatment period for the following reasons: lack of efficacy (11), subject withdrawal (6), adverse events (10), protocol deviations (3), lost to follow-up (1)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo BID x 16 weeks

    Reporting group title
    OPN-375 100 μg
    Reporting group description
    		 OPN-375 100 μg BID x 16 weeks,

    Reporting group title
    OPN-375 200 μg
    Reporting group description
    		 OPN-375 200 μg BID x 16 weeks

    Reporting group title
    OPN-375 400 μg
    Reporting group description
    		 OPN-375 400 μg BID x 16 weeks

    Reporting group values
    		 Placebo OPN-375 100 μg OPN-375 200 μg OPN-375 400 μg Total
    Number of subjects
    		 82 81 80 80 323
    Age categorical
    Age ranges for data collection in this study were 18-65 years and >/= 65 years. There were no patients in the age range of >/= 65 years.
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
        Adults (18 - 65 years)
    		 82 81 80 80 323
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ± 13.0 44.9 ± 12.7 46.4 ± 12.7 43.9 ± 12.6 -
    Gender categorical
    Units: Subjects
        Female
    		 46 41 32 42 161
        Male
    		 36 40 48 38 162
    Race / Ethnicity
    Units: Subjects
        White
    		 68 74 72 69 283
        Black/African American
    		 8 3 6 9 26
        Asian
    		 5 2 2 0 9
        Other
    		 1 2 0 2 5
    Use of intranasal corticosteroid (ICS) treatment for polyps in past 10 years
    Units: Subjects
        Yes
    		 77 77 76 75 305
        No
    		 5 4 4 5 18
    Previous sinus surgery for polyp removal or sinus surgery
    Patients may have had both sinus surgery and polypectomy.
    Units: Subjects
        Yes
    		 33 34 27 30 124
        No
    		 49 47 53 50 199
    Previous polyp removal surgery via polypectomy only
    Patients may have had both sinus surgery and polypectomy.
    Units: Subjects
        Yes
    		 33 27 33 27 120
        No
    		 49 54 47 53 203

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo BID x 16 weeks

    Reporting group title
    OPN-375 100 μg
    Reporting group description
    		 OPN-375 100 μg BID x 16 weeks,

    Reporting group title
    OPN-375 200 μg
    Reporting group description
    		 OPN-375 200 μg BID x 16 weeks

    Reporting group title
    OPN-375 400 μg
    Reporting group description
    		 OPN-375 400 μg BID x 16 weeks
    Reporting group title
    OPN-375 400 μg - open label
    Reporting group description
    		 OPN-375 400 μg (open-label) BID x 8 weeks

    Primary: Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms

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    End point title
    		 Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
    End point description
    The Full Analysis Set was used for all efficacy analyses unless otherwise specified. Subjects reported nasal symptoms using the e-diary 2x/day immediately before dosing. 0: None 1: Mild, symptoms clearly present, but minimal awareness, and easily tolerated 2: Moderate, definite awareness of symptoms that is bothersome but tolerable 3: Severe, symptoms that are hard to tolerate, cause interference with activities or daily living The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of t
    End point type
    Primary
    End point timeframe
    Baseline, Week 4 of the double-blind treatment phase
    End point values
    		 Placebo OPN-375 100 μg OPN-375 200 μg OPN-375 400 μg
    Number of subjects analysed
    82
    81
    80
    79
    Units: Units on a scale
    least squares mean (standard error)
        Units on a scale
    -0.24 ± 0.074
    -0.49 ± 0.076
    -0.54 ± 0.075
    -0.62 ± 0.075
    Statistical analysis title
    		 Change in instantaneous AM ADS7-IA
    Statistical analysis description
    Inferential statistics were derived from a generalized linear model with treatment and country factors and baseline ADS7-IA score for nasal congestion / obstruction as a covariate.
    Comparison groups
    Placebo v OPN-375 100 μg v OPN-375 200 μg v OPN-375 400 μg
    Number of subjects included in analysis
    322
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Generalized linear model
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.16
    Variability estimate
    Standard error of the mean
    Notes
    [1] - P value all 3 experimental arms versus placebo

    Primary: Change in Total Polyp Grade

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    End point title
    		 Change in Total Polyp Grade
    End point description
    The Full Analysis Set was used for all efficacy analyses unless otherwise specified. Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps 1: Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2: Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3: Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline
    End point type
    Primary
    End point timeframe
    Baseline, Week 16 of the double-blind treatment phase
    End point values
    		 Placebo OPN-375 100 μg OPN-375 200 μg OPN-375 400 μg
    Number of subjects analysed
    82
    81
    80
    79
    Units: Units on a scale
    least squares mean (standard error)
        Units on a scale
    -0.45 ± 0.135
    -0.96 ± 0.139
    -1.03 ± 0.138
    -1.06 ± 0.137
    Statistical analysis title
    		 Change in total polyp grade
    Statistical analysis description
    The change from baseline to the Week 16 assessment was analyzed using a mixed effect model for repeated measures (MMRM). The data included for each subject, the changes in bilateral polyp score from baseline to each subsequent assessment with nasoendoscopy. The MMRM model included a covariate (baseline bilateral polyp score) and the following fixed effects: treatment (400 µg, 200 µg, 100 µg, and placebo), country (6 levels), visit (4 level) and the interaction of treatment-by-visit.
    Comparison groups
    Placebo v OPN-375 100 μg v OPN-375 200 μg v OPN-375 400 μg
    Number of subjects included in analysis
    322
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [2] - P value of 3 experimental arms versus placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of Screening until completion of the end-of open-label extension visit or an early termination visit (either during double-blind or open-label phase). SAEs were reported through 30 days after last dose of study drug administration.
    Adverse event reporting additional description
    Safety was assessed via typical assessment of spontaneous AE reporting on the part of the subject as well as through vital signs, protocol-defined nasal examination via nasal endoscopy by a specialist and protocol-defined ocular examination, including slit lamp exam, tonometry, and visual acuity, by an ophthalmologist
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo BID x 16 weeks

    Reporting group title
    100 μg OPN-375
    Reporting group description
    		 OPN-375 100 μg BID x 16 weeks,

    Reporting group title
    200 μg OPN-375
    Reporting group description
    		 OPN-375 200 μg BID x 16 weeks

    Reporting group title
    400 μg OPN-375
    Reporting group description
    		 OPN-375 400 μg BID x 16 weeks

    Reporting group title
    OPN-375 400 μg (Open-label)
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 100 μg OPN-375 200 μg OPN-375 400 μg OPN-375 OPN-375 400 μg (Open-label)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    2 / 282 (0.71%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal Polyps
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo 100 μg OPN-375 200 μg OPN-375 400 μg OPN-375 OPN-375 400 μg (Open-label)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 82 (51.22%)
    40 / 81 (49.38%)
    45 / 80 (56.25%)
    50 / 79 (63.29%)
    38 / 282 (13.48%)
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 81 (0.00%)
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Intraocular pressure increased
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 282 (0.35%)
         occurrences all number
    2
    1
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 81 (2.47%)
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    2 / 282 (0.71%)
         occurrences all number
    2
    2
    2
    0
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 81 (2.47%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 282 (0.35%)
         occurrences all number
    1
    2
    0
    0
    1
    Eye disorders
    Cataract nuclear
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 282 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Vomiting
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Spontaneously reported by Subject or found on Nasoendoscopy
         subjects affected / exposed
    6 / 82 (7.32%)
    11 / 81 (13.58%)
    16 / 80 (20.00%)
    19 / 79 (24.05%)
    16 / 282 (5.67%)
         occurrences all number
    6
    11
    16
    19
    16
    Nasal mucosal disorder
         subjects affected / exposed
    5 / 82 (6.10%)
    11 / 81 (13.58%)
    6 / 80 (7.50%)
    6 / 79 (7.59%)
    1 / 282 (0.35%)
         occurrences all number
    5
    11
    6
    6
    1
    Nasal septal ulceration
         subjects affected / exposed
    1 / 82 (1.22%)
    5 / 81 (6.17%)
    5 / 80 (6.25%)
    4 / 79 (5.06%)
    5 / 282 (1.77%)
         occurrences all number
    1
    5
    5
    4
    5
    Nasal congestion
         subjects affected / exposed
    4 / 82 (4.88%)
    3 / 81 (3.70%)
    2 / 80 (2.50%)
    6 / 79 (7.59%)
    1 / 282 (0.35%)
         occurrences all number
    4
    3
    2
    6
    1
    Nasal septum disorder
         subjects affected / exposed
    1 / 82 (1.22%)
    3 / 81 (3.70%)
    2 / 80 (2.50%)
    3 / 79 (3.80%)
    1 / 282 (0.35%)
         occurrences all number
    1
    3
    2
    3
    1
    Asthma
         subjects affected / exposed
    5 / 82 (6.10%)
    0 / 81 (0.00%)
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    1 / 282 (0.35%)
         occurrences all number
    5
    0
    1
    3
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 81 (0.00%)
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    3 / 82 (3.66%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    4 / 82 (4.88%)
    5 / 81 (6.17%)
    6 / 80 (7.50%)
    8 / 79 (10.13%)
    3 / 282 (1.06%)
         occurrences all number
    4
    5
    6
    8
    3
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 82 (8.54%)
    1 / 81 (1.23%)
    4 / 80 (5.00%)
    5 / 79 (6.33%)
    2 / 282 (0.71%)
         occurrences all number
    7
    1
    4
    5
    2
    Nasopharyngitis
         subjects affected / exposed
    4 / 82 (4.88%)
    3 / 81 (3.70%)
    2 / 80 (2.50%)
    4 / 79 (5.06%)
    3 / 282 (1.06%)
         occurrences all number
    4
    3
    2
    4
    3
    Bronchitis
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 81 (2.47%)
    2 / 80 (2.50%)
    3 / 79 (3.80%)
    0 / 282 (0.00%)
         occurrences all number
    2
    2
    2
    3
    0
    Influenza
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 81 (2.47%)
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    0 / 282 (0.00%)
         occurrences all number
    3
    2
    2
    2
    0
    Pharyngitis
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 81 (0.00%)
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    0 / 282 (0.00%)
         occurrences all number
    2
    0
    1
    3
    0
    Otitis media
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 81 (2.47%)
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    1 / 282 (0.35%)
         occurrences all number
    1
    2
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 282 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jan 2013
    The amendment included clarification for the scheduled study procedures and evaluations, in addition to clarification for the efficacy assessments for polyp grading.
    07 Mar 2013
    The amendment included changes to the nasoendoscopy procedures to reduce burden for the subject. Additional guidance was also added to scheduled study procedures and evaluations, and efficacy assessments.
    18 Dec 2013
    The amendment included additional clarification to the scheduled study procedures including the addition of the ophthalmology worksheet and change to the stratification.

    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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