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    Clinical Trial Results:
    Effect of the CRTH2 antagonist OC459 on the response to rhinovirus challenge in asthma

    Summary
    EudraCT number
    		 2015-002555-10
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2019
    First version publication date
    13 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ORCA2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02660489
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College
    Sponsor organisation address
    St Mary's Medical School Building, Norfolk Place, London, United Kingdom, W2 1PG
    Public contact
    Professor Sebastian Johnston, Imperial College, +44 20 7594 3849, s.johnston@imperial.ac.uk
    Scientific contact
    Professor Sebastian Johnston, Imperial College, +44 20 7594 3849, s.johnston@imperial.ac.uk
    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
    22 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall aim of this study is to assess the effectiveness of the study drug (OC459) in preventing or attenuating the worsening of asthma symptoms (an asthma exacerbation) that occurs when asthma sufferers catch a cold (defined as an infection with the virus rhinovirus). The study drug will be compared with a placebo to find out the extent of any improvement in the condition of the participants. A placebo is a medically noneffective copy of the drug being tested; it looks and tastes the same as the treatment drug (it can be seen as a dummy drug). In healthy subjects, rhinovirus infection causes symptoms of a cold e.g. sneezing, runny nose. In patients with asthma, rhinovirus infection causes a worsening of their asthma symptoms (e.g. breathlessness, wheeze) because of the way the immune system reacts to the virus. The study drug OC459 blocks activation of receptor cells found in the immune system and by blocking that activation may prevent an exacerbation of symptoms.
    Protection of trial subjects
    There were 11 scheduled visits for trial subjects, with seven of these scheduled during the period when subjects had a cold. In addition subjects had access to the study team via mobile and email 24/7. A procedure for unblinding was also available 24/7.
    Background therapy
    		 Subjects were told to continue their usual medication as prescribed. This included inhaled corticosteriods ('preventers') and inhaled short-acting beta agonists ('relievers').
    Evidence for comparator
    		 A placebo was given in the comparator arm.
    Actual start date of recruitment
    18 Jan 2016
    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 Kingdom: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment ran from 18 January 2016 until completion (November 2018; the last subjects were enrolled on 15 November 2018). This was a single site study.

    Pre-assignment
    Screening details
    		 Volunteers who were potentially eligible for inclusion were screened by an Asthma Control Questionnaire, skin prick test, bronchoprovocation testing (using histamine) and rhinovirus serology (looking for evidence of antibodies to rhinovirus serotype 16).

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The unblinded randomisation list was generated by a statistician working independently of the trial and entered into the study database. The unblinded randomisation list was also provided to the drug manufacturer in order to label the drug/placebo appropriately prior to dispensing to pharmacy. In this way the subjects, investigators, pharmacy, trial statisticians and study monitors were all blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OC459
    Arm description
    		 Subjects randomised to treatment with OC459 50mg once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OC459
    Investigational medicinal product code
    Other name
    Timapiprant
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg once daily for five weeks

    Arm title
    		 Placebo
    Arm description
    		 Subjects randomised to treatment with placebo once daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once daily for five weeks

    Number of subjects in period 1
    		OC459 Placebo
    Started
    22
    22
    Completed
    20
    18
    Not completed
    2
    4
         Incidental respiratory tract infection
    -
    3
         Non-attendance at study visit
    1
    1
         Incidental respiratory viral infection
    1
    -
    Period 2
    Period 2 title
    Rhinovirus infection
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    (as per previous period)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OC459 - confirmed rhinovirus infection
    Arm description
    		 Subjects randomised to treatment with OC459 in whom infection with rhinovirus-16 was confirmed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OC459
    Investigational medicinal product code
    Other name
    Timapiprant
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg once daily for five weeks

    Arm title
    		 Placebo - confirmed rhinovirus infection
    Arm description
    		 Subjects randomised to treatment with placebo in whom infection with rhinovirus-16 was confirmed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once daily for five weeks

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: As per the Protocol and Statistical Analysis Plan, the full analysis set includes only subjects who have been randomised and in addition have confirmed rhinovirus-16 infection and completed at least 14 days post inoculation with rhinovirus-16. The baseline characteristics are provided for the Full Analysis Set, not the subjects enrolled, given the outcome analyses are performed on the Full Analysis Set.
    Number of subjects in period 2 [2] [3]
    		OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Started
    16
    14
    Completed
    16
    14
    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: As per the Protocol and Statistical Analysis Plan, the full analysis set includes only subjects who have been randomised and in addition have confirmed rhinovirus-16 infection and completed at least 14 days post inoculation with rhinovirus-16.
    [3] - 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: As per the Protocol and Statistical Analysis Plan, the full analysis set includes only subjects who have been randomised and in addition have confirmed rhinovirus-16 infection and completed at least 14 days post inoculation with rhinovirus-16.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OC459 - confirmed rhinovirus infection
    Reporting group description
    		 Subjects randomised to treatment with OC459 in whom infection with rhinovirus-16 was confirmed.

    Reporting group title
    Placebo - confirmed rhinovirus infection
    Reporting group description
    		 Subjects randomised to treatment with placebo in whom infection with rhinovirus-16 was confirmed.

    Reporting group values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection Total
    Number of subjects
    		 16 14 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.1 ( 9.0 ) 24.8 ( 3.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 7 5 12

    End points

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    End points reporting groups
    Reporting group title
    OC459
    Reporting group description
    		 Subjects randomised to treatment with OC459 50mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised to treatment with placebo once daily.
    Reporting group title
    OC459 - confirmed rhinovirus infection
    Reporting group description
    		 Subjects randomised to treatment with OC459 in whom infection with rhinovirus-16 was confirmed.

    Reporting group title
    Placebo - confirmed rhinovirus infection
    Reporting group description
    		 Subjects randomised to treatment with placebo in whom infection with rhinovirus-16 was confirmed.

    Primary: Total Lower Respiratory Symptom score

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    End point title
    		 Total Lower Respiratory Symptom score
    End point description
    End point type
    Primary
    End point timeframe
    Sum of daily scores for 14 days after rhinovirus inoculation
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: score on a scale
        median (inter-quartile range (Q1-Q3))
    21 (13.3 to 46.5)
    18 (4 to 121)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Asthma Control Questionnaire (ACQ)-6 score

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    End point title
    		 Asthma Control Questionnaire (ACQ)-6 score
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline (rhinovirus inoculation, day 0) to day 10
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.01 ( 0.68 )
    0.17 ( 0.71 )
    Statistical analysis title
    		 Unpaired T-test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Peak Expiratory Flow Rate

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    End point title
    		 Peak Expiratory Flow Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Percentage change from baseline (rhinovirus inoculation, day 0) to trough during infection (up to day 14)
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: percentage change
        arithmetic mean (standard deviation)
    -16.9 ( 10.2 )
    -13.1 ( 12.8 )
    Statistical analysis title
    		 Unpaired T-test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    Percentage change from baseline (rhinovirus inoculation, day 0) to trough during infection (up to day 14)
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: percentage change
        arithmetic mean (standard deviation)
    -18.5 ( 11.3 )
    -12.7 ( 14.0 )
    Statistical analysis title
    		 Unpaired T-test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Exhaled nitric oxide (FeNO)

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    End point title
    		 Exhaled nitric oxide (FeNO)
    End point description
    End point type
    Secondary
    End point timeframe
    Percentage change from baseline (rhinovirus inoculation, day 0) to peak during infection (measured on days 3, 5, 7, 10 post inoculation)
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: percentage change
        median (inter-quartile range (Q1-Q3))
    58 (27 to 101)
    23 (0 to 77)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Placebo - confirmed rhinovirus infection v OC459 - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Airway Hyperresponsiveness (Assessed as the Provocation Concentration of Histamine Producing a 20% Fall in FEV1, or PC20)

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    End point title
    		 Airway Hyperresponsiveness (Assessed as the Provocation Concentration of Histamine Producing a 20% Fall in FEV1, or PC20)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline (rhinovirus inoculation, day 0) to day 7
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    15 [1]
    13 [2]
    Units: mg/mL histamine
        median (inter-quartile range (Q1-Q3))
    -0.1 (-0.77 to 0.21)
    -0.64 (-2.19 to -0.31)
    Notes
    [1] - One subject could not complete one of the two measurements owing to logistical issues.
    [2] - One subject could not complete one of the two measurements owing to logistical issues.
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Viral Load (in Nasal Lavage Samples)

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    End point title
    		 Viral Load (in Nasal Lavage Samples)
    End point description
    End point type
    Secondary
    End point timeframe
    Peak during infection (up to day 14)
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: viral copies / mL
        median (full range (min-max))
    445861 (0 to 9025667)
    215782 (0 to 25240371)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total Upper Respiratory Symptom Score

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    End point title
    		 Total Upper Respiratory Symptom Score
    End point description
    End point type
    Secondary
    End point timeframe
    Sum of daily scores for 14 days after rhinovirus inoculation
    End point values
    		 OC459 - confirmed rhinovirus infection Placebo - confirmed rhinovirus infection
    Number of subjects analysed
    16
    14
    Units: score on a scale
        median (inter-quartile range (Q1-Q3))
    33 (20.5 to 63.3)
    41 (18.5 to 63.8)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    OC459 - confirmed rhinovirus infection v Placebo - confirmed rhinovirus infection
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Nine weeks' study duration, including the first five weeks during which subjects were treated with OC459/placebo.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none used
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    OC459
    Reporting group description
    		 All subjects randomised to OC459

    Reporting group title
    Placebo
    Reporting group description
    		 All subjects randomised to placebo

    Serious adverse events
    		 OC459 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OC459 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 22 (9.09%)
         occurrences all number
    17
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2017
    Increase in recruitment target owing to lower infection rate and higher number of drop outs than anticipated.
    11 Jul 2017
    Increase in recruitment target as subjects enrolled had fewer asthma symptoms than anticipated.

    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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