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    Clinical Trial Results:
    A phase II, randomised, double blind, placebo controlled, six way crossover study to assess the bronchodilator effect of RPL554 administered on top of salbutamol and ipratropium in patients with COPD

    Summary
    EudraCT number
    		 2015-002536-41
    Trial protocol
    		 GB  
    Global end of trial date
    17 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2017
    First version publication date
    04 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RPL554-009-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02542254
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Verona Pharma plc
    Sponsor organisation address
    3 More London Riverside, London, United Kingdom, SE1 2RE
    Public contact
    Kenneth Newman, Verona Pharma plc, +44 203 283 4200, ken.newman@veronapharma.com
    Scientific contact
    Kenneth Newman, Verona Pharma plc, +44 203 283 4200, ken.newman@veronapharma.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
    17 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the bronchodilator effect on lung function over 8 hours of single nebulised doses of RPL554, as compared to placebo, when administered in addition to standard care bronchodilators (salbutamol, ipratropium) or placebo.
    Protection of trial subjects
    Standard procedures for emergency care were followed for any individual adverse events if clinically needed. Short acting bronchodilators could be used as rescue medication.
    Background therapy
    		 Short acting bronchodilators could be used as rescue medication.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    23
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was consented on 28 September 2015. Overall, 71 patients were screened for the study and 36 were treated . Patients received study treatment between 7 October 2015 and 14 December 2015. A total of 30 patients completed the study and six were withdrawn

    Pre-assignment
    Screening details
    		 71 patients were screened. The main reasons for screen failure were reversibility test criteria not met (7 patients), ECG or blood pressure abnormal (7 patients) and unsuitable medical history (6 patients). Patients had to discontinue LABAs and LAMAs on the day of screening and SABAs and SAMAs for 8 hours before all spirometry.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Salbutamol and RPL554
    Arm description
    		 200 ug salbutamol pMDI and 6 mg nebulised RPL554
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    200 ug by pressurised metered dose inhaler

    Investigational medicinal product name
    RPL554
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    6 mg RPL554 administered using a nebuliser

    Arm title
    		 Salbutamol
    Arm description
    		 200 ug salbutamol pMDI. Nebulised placebo was also given to effect a double dummy design
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    200 mcg by pressurised metered dose inhaler

    Arm title
    		 Ipratropium and RPL554
    Arm description
    		 40 ug ipratropium pMDI and 6 mg nebulised RPL554
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ipratropium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    40 ug by pressurised metered dose inhaler

    Investigational medicinal product name
    RPL554
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    6 mg RPL554 administered using a nebuliser

    Arm title
    		 Ipratropium
    Arm description
    		 40 ug ipratropium pMDI. Nebulised placebo was also given to effect a double dummy design
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ipratropium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    40 ug ipratropium administered using a pMDI

    Arm title
    		 RPL554
    Arm description
    		 6 mg nebulised RPL554. A placebo pMDI was also given to effect a double dummy design
    Arm type
    		 Experimental

    Investigational medicinal product name
    RPL554
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    6 mg RPL554 administered using a nebuliser

    Arm title
    		 Placebo
    Arm description
    		 Nebulised placebo and placebo pMDI
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo given by nebuliser

    Number of subjects in period 1
    		Salbutamol and RPL554 Salbutamol Ipratropium and RPL554 Ipratropium RPL554 Placebo
    Started
    31
    32
    34
    33
    31
    31
    Completed
    31
    32
    33
    32
    31
    31
    Not completed
    0
    0
    1
    1
    0
    0
         Adverse event, non-fatal
    -
    -
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 36 36
    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
        median (full range (min-max))
    		 62 (52 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 17 17
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Salbutamol and RPL554
    Reporting group description
    		 200 ug salbutamol pMDI and 6 mg nebulised RPL554

    Reporting group title
    Salbutamol
    Reporting group description
    		 200 ug salbutamol pMDI. Nebulised placebo was also given to effect a double dummy design

    Reporting group title
    Ipratropium and RPL554
    Reporting group description
    		 40 ug ipratropium pMDI and 6 mg nebulised RPL554

    Reporting group title
    Ipratropium
    Reporting group description
    		 40 ug ipratropium pMDI. Nebulised placebo was also given to effect a double dummy design

    Reporting group title
    RPL554
    Reporting group description
    		 6 mg nebulised RPL554. A placebo pMDI was also given to effect a double dummy design

    Reporting group title
    Placebo
    Reporting group description
    		 Nebulised placebo and placebo pMDI

    Primary: Peak FEV1

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    End point title
    		 Peak FEV1
    End point description
    End point type
    Primary
    End point timeframe
    Over 8 hours post-dose
    End point values
    		 Salbutamol and RPL554 Salbutamol Ipratropium and RPL554 Ipratropium RPL554 Placebo
    Number of subjects analysed
    31
    32
    32
    31
    30
    31
    Units: Litres
        arithmetic mean (standard deviation)
    1.713 ( 0.4339 )
    1.624 ( 0.4378 )
    1.7 ( 0.4364 )
    1.596 ( 0.426 )
    1.635 ( 0.423 )
    1.418 ( 0.3863 )
    Statistical analysis title
    		 Peak FEV1 Salbutamol/RPL554 vs salbutamol
    Comparison groups
    Salbutamol and RPL554 v Salbutamol
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Ipratropium/RPL554 vs ipratropium
    Comparison groups
    Ipratropium and RPL554 v Ipratropium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Salbutamol/RPL554 vs Ipratropium/RPL554
    Comparison groups
    Ipratropium and RPL554 v Salbutamol and RPL554
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.998
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Salbutamol/RPL554 vs RPL554
    Comparison groups
    Salbutamol and RPL554 v RPL554
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Ipratropium/RPL554 vs RPL554
    Comparison groups
    RPL554 v Ipratropium and RPL554
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Salbutamol vs Ipratropium
    Comparison groups
    Salbutamol v Ipratropium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.737
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Salbutamol vs Placebo
    Comparison groups
    Salbutamol v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 Ipratropium vs Placebo
    Comparison groups
    Placebo v Ipratropium
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Peak FEV1 RPL554 vs Placebo
    Comparison groups
    Placebo v RPL554
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Primary: AUC FEV1

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    End point title
    		 AUC FEV1
    End point description
    End point type
    Primary
    End point timeframe
    Over 8 hours post-dose
    End point values
    		 Salbutamol and RPL554 Salbutamol Ipratropium and RPL554 Ipratropium RPL554 Placebo
    Number of subjects analysed
    31
    32
    32
    31
    30
    31
    Units: Litres
        arithmetic mean (standard deviation)
    1.548 ( 0.4347 )
    1.453 ( 0.4262 )
    1.531 ( 0.4224 )
    1.462 ( 0.4227 )
    1.477 ( 0.4287 )
    1.317 ( 0.4031 )
    Statistical analysis title
    		 AUC FEV1 Salbutamol/RPL554 vs Salbutamol
    Comparison groups
    Salbutamol and RPL554 v Salbutamol
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Ipratropium/RPL554 vs Ipratropium
    Comparison groups
    Ipratropium and RPL554 v Ipratropium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Salbutamol/RPL554 vs Ipratropium/RPL554
    Comparison groups
    Ipratropium and RPL554 v Salbutamol and RPL554
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.97
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Salbutamol/RPL554 vs RPL554
    Comparison groups
    Salbutamol and RPL554 v RPL554
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Ipratropium/RPL554 vs R...
    Comparison groups
    RPL554 v Ipratropium and RPL554
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Salbutamol vs ipratropium
    Comparison groups
    Salbutamol v Ipratropium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Salbutamol vs placebo
    Comparison groups
    Salbutamol v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 Ipratropium vs placebo
    Comparison groups
    Placebo v Ipratropium
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 AUC FEV1 RPL554 vs placebo
    Comparison groups
    Placebo v RPL554
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to end of study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Salbutamol and RPL554
    Reporting group description
    		 -

    Reporting group title
    Salbutamol
    Reporting group description
    		 -

    Reporting group title
    Ipratropium and RPL554
    Reporting group description
    		 -

    Reporting group title
    Ipratropium
    Reporting group description
    		 -

    Reporting group title
    RPL554
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Salbutamol and RPL554 Salbutamol Ipratropium and RPL554 Ipratropium RPL554 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Salbutamol and RPL554 Salbutamol Ipratropium and RPL554 Ipratropium RPL554 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 31 (45.16%)
    16 / 32 (50.00%)
    13 / 33 (39.39%)
    9 / 32 (28.13%)
    7 / 31 (22.58%)
    11 / 31 (35.48%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    2
    2
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    1
    1
    0
    1
    Headache
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    Migraine
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Catheter site bruise
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    Cough
         subjects affected / exposed
    5 / 31 (16.13%)
    7 / 32 (21.88%)
    8 / 33 (24.24%)
    2 / 32 (6.25%)
    4 / 31 (12.90%)
    4 / 31 (12.90%)
         occurrences all number
    5
    7
    8
    2
    4
    4
    Dyspnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    1
    1
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    2
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    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
    20 Aug 2015
    Amend window between Visits 7 and 8 from 2-10 days to 3-10 days Addition of exclusion criteria: 21. Patients with known hypersensitivity to atropine or its derivatives, or to ipratropium bromide or its excipients. 22. Patients with known hypersensitivity to salbutamol or its excipients. 23. Patients with known hypersensitivity to RPL554 or its excipients/components.

    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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