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    Clinical Trial Results:
    A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy

    Summary
    EudraCT number
    		 2011-005030-19
    Trial protocol
    		 GB   DE   HU   PL   BG   ES  
    Global end of trial date
    31 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2016
    First version publication date
    22 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VR506/2/004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01720069
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number : 107310
    Sponsors
    Sponsor organisation name
    Vectura Limited
    Sponsor organisation address
    1 Prospect West, Chippenham, United Kingdom,
    Public contact
    Clinical Trials Information, Vectura Limited, +44 1249667700, clinical.enquiries@vectura.com
    Scientific contact
    Clinical Trials Information, Vectura Limited, +44 1249667700, clinical.enquiries@vectura.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
    31 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011).
    Protection of trial subjects
    There are no specific measures for protection of patients.
    Background therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 49
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Bulgaria: 19
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Romania: 49
    Country: Number of subjects enrolled
    Ukraine: 47
    Worldwide total number of subjects
    196
    EEA total number of subjects
    139
    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)
    1
    Adults (18-64 years)
    195
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period covered 29 October 2012 to 31 October 2013. Subjects were screened at 61 sites in 8 countries: Bulgaria, Germany, Hungary, Poland, Romania, Ukraine, United Kingdom (UK) and United States of America (USA).

    Pre-assignment
    Screening details
    		 Subjects were screened at 61 sites in 8 countries: Bulgaria, Germany, Hungary, Poland, Romania, Ukraine, UK & US. Total of 285 subjects were screened of whom 197 from 56 sites were randomised. 1 subject in Romania was randomised, not treated. So only 196 were treated . 88 subjects failed screening, 35 discontinued during treatment period.

    Period 1
    Period 1 title
    Randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Double-blind conditions were secured by the identical appearance of 3 strengths of the Test Product. Due to the coded labelling of the IMPs, neither site personnel nor subject knew which treatment was being administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test product 1
    Arm description
    		 Fluticasone Propionate Inhalation Powder 50ug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50ug Inhalation Powder per actuation. Self administered twice daily

    Investigational medicinal product name
    Fluticasone Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50ug Inhalation Powder per actuation. Self administered twice daily

    Arm title
    		 Test Product 2
    Arm description
    		 Fluticasone Propionate Inhalation Powder 250ug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    250ug Inhalation Powder per actuation. Self administered twice daily

    Arm title
    		 Test Product 3
    Arm description
    		 Fluticasone Propionate Inhalation Powder 500ug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    500ug Inhalation Powder per actuation. Self administered twice daily

    Number of subjects in period 1
    		Test product 1 Test Product 2 Test Product 3
    Started
    62
    71
    63
    Completed
    57
    56
    48
    Not completed
    5
    15
    15
         Consent withdrawn by subject
    -
    2
    1
         Non-compliance on using e-diary
    -
    -
    1
         Asthma exacerbation
    -
    4
    -
         Adverse event, non-fatal
    -
    -
    1
         OCS bursts occured, discontinued in line with IWRS
    1
    -
    -
         Could not use e-diary correctly
    -
    1
    1
         Treatment period withdrawal criteria met
    4
    8
    9
         Lost to follow-up
    -
    -
    1
         Randomised without baseline values
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test product 1
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 50ug

    Reporting group title
    Test Product 2
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 250ug

    Reporting group title
    Test Product 3
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 500ug

    Reporting group values
    		 Test product 1 Test Product 2 Test Product 3 Total
    Number of subjects
    		 62 71 63 196
    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
        Adolescents (12-17 years)
    		 0 1 0 1
        Children (2-11 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 62 70 63 195
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 40 45 42 127
        Male
    		 22 26 21 69
    Ethnic group
    Units: Subjects
        White
    		 60 70 62 192
        Black or African American
    		 2 0 1 3
        Other
    		 0 1 0 1
    Country
    Units: Subjects
        Bulgaria
    		 6 7 6 19
        Germany
    		 4 3 3 10
        Hungary
    		 3 3 4 10
        Poland
    		 15 18 16 49
        Romania
    		 16 17 16 49
        Ukraine
    		 15 18 14 47
        UK
    		 1 1 0 2
        US
    		 2 4 4 10

    End points

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    End points reporting groups
    Reporting group title
    Test product 1
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 50ug

    Reporting group title
    Test Product 2
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 250ug

    Reporting group title
    Test Product 3
    Reporting group description
    		 Fluticasone Propionate Inhalation Powder 500ug

    Primary: Prednisone/Prednisolone Dose for Analysis (PDA)

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    End point title
    		 Prednisone/Prednisolone Dose for Analysis (PDA)
    End point description
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: mg
        arithmetic mean (standard deviation)
    4.55 ( 6.85 )
    4.31 ( 7.38 )
    3.97 ( 6.21 )
    Statistical analysis title
    		 Prednisone/Prednisolone Dose for Analysis (PDA)
    Comparison groups
    Test product 1 v Test Product 2 v Test Product 3
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: In-clinic morning pre-dose FEV1

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    End point title
    		 In-clinic morning pre-dose FEV1
    End point description
    This secondary endpoint measures the mean change in the in-clinic morning pre-dose FEV1 from baseline to end of study. FEV1 is measured in Litres (L).
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: FEV1
        arithmetic mean (standard deviation)
    0.06 ( 0.4 )
    0.02 ( 0.31 )
    0.06 ( 0.35 )
    Statistical analysis title
    		 In-clinic morning pre-dose FEV1
    Statistical analysis description
    FEV1 is measured in Litres (L)
    Comparison groups
    Test Product 2 v Test Product 3 v Test product 1
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: ACQ-5 total score

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    End point title
    		 ACQ-5 total score
    End point description
    To measure the change from baseline to end of study in ACQ-5 mean total score
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: ACQ-5 Mean total score
        arithmetic mean (standard deviation)
    -0.67 ( 0.98 )
    -0.77 ( 1.15 )
    -0.39 ( 0.89 )
    Statistical analysis title
    		 ACQ-5 Total Score
    Comparison groups
    Test product 1 v Test Product 2 v Test Product 3
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Weekly average morning pre-dose PEF

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    End point title
    		 Weekly average morning pre-dose PEF
    End point description
    To measure the change from baseline to end of study in the weekly mean morning pre-dose PEF.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: L/min
        arithmetic mean (standard deviation)
    2 ( 45.7 )
    20.1 ( 51.7 )
    6.1 ( 53.5 )
    Statistical analysis title
    		 Weekly average morning pre-dose PEF
    Comparison groups
    Test product 1 v Test Product 2 v Test Product 3
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Weekly average asthma night-time symptom score

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    End point title
    		 Weekly average asthma night-time symptom score
    End point description
    To measure the change from baseline to end of study for the weekly mean asthma night time symptom score .
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: Symptom score
        arithmetic mean (standard deviation)
    -0.3 ( 1 )
    -0.6 ( 1 )
    -0.2 ( 1 )
    Statistical analysis title
    		 Weekly average asthma night-time symptom score
    Comparison groups
    Test product 1 v Test Product 2 v Test Product 3
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Withdrawals due to worsening of asthma

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    End point title
    		 Withdrawals due to worsening of asthma
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: Number of patient withdrawals
    4
    11
    8
    Statistical analysis title
    		 Number of withdrawals due to worsening of asthma
    Statistical analysis description
    Arm 1 versus Arm 2
    Comparison groups
    Test product 1 v Test Product 2
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of withdrawals due to worsening of asthma
    Statistical analysis description
    Arm 1 versus Arm 3
    Comparison groups
    Test product 1 v Test Product 3
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of withdrawals due to worsening of asthma
    Statistical analysis description
    Arm 2 and Arm 3
    Comparison groups
    Test Product 2 v Test Product 3
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of subjects stopping oral corticosteroid (OCS) treatment

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    End point title
    		 Proportion of subjects stopping oral corticosteroid (OCS) treatment
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: Number of subjects stopping OCS
    29
    23
    24
    Statistical analysis title
    		 Proportion of subjects stopping OCS Arm 1 v Arm 2
    Comparison groups
    Test Product 2 v Test product 1
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Proportion of subjects stopping OCS Arm 1 v Arm 3
    Comparison groups
    Test Product 3 v Test product 1
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Proportion of subjects stopping OCS Arm 2 v Arm 3
    Comparison groups
    Test Product 2 v Test Product 3
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Number of Subjects with Asthma Exacerbations

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    End point title
    		 Number of Subjects with Asthma Exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: Number of subjects with Exacerbations
    11
    26
    10
    Statistical analysis title
    		 Number of Subjects with Asthma Exacerbations
    Comparison groups
    Test Product 2 v Test product 1
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of Subjects with Asthma Exacerbations
    Comparison groups
    Test product 1 v Test Product 3
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Number of Subjects with Asthma Exacerbations
    Comparison groups
    Test Product 2 v Test Product 3
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion subjects achieving asthma control OCS dose

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    End point title
    		 Proportion subjects achieving asthma control OCS dose
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Test product 1 Test Product 2 Test Product 3
    Number of subjects analysed
    62
    71
    63
    Units: Subjects achieving asthma control
    47
    43
    42
    Statistical analysis title
    		 Proportion subjects achieving asthma control
    Statistical analysis description
    Proportion subjects achieving asthma control OCS dose
    Comparison groups
    Test Product 2 v Test product 1
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Proportion subjects achieving asthma control
    Statistical analysis description
    Proportion subjects achieving asthma control OCS dose
    Comparison groups
    Test Product 3 v Test product 1
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Proportion subjects achieving asthma control
    Statistical analysis description
    Proportion subjects achieving asthma control OCS dose
    Comparison groups
    Test Product 2 v Test Product 3
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Test Product 1
    Reporting group description
    		 -

    Reporting group title
    Test Product 2
    Reporting group description
    		 -

    Reporting group title
    Test Product 3
    Reporting group description
    		 -

    Serious adverse events
    		 Test Product 1 Test Product 2 Test Product 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 71 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Test Product 1 Test Product 2 Test Product 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 62 (33.87%)
    33 / 71 (46.48%)
    25 / 63 (39.68%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 62 (3.23%)
    4 / 71 (5.63%)
    1 / 63 (1.59%)
         occurrences all number
    3
    4
    1
    Dizziness
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 71 (2.82%)
    0 / 63 (0.00%)
         occurrences all number
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    12 / 62 (19.35%)
    26 / 71 (36.62%)
    12 / 63 (19.05%)
         occurrences all number
    15
    35
    16
    Oropharyngeal pain
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 71 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    2
    0
    2
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 71 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    0
    3
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 71 (1.41%)
    2 / 63 (3.17%)
         occurrences all number
    2
    1
    3
    Acute sinusitis
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 71 (4.23%)
    1 / 63 (1.59%)
         occurrences all number
    0
    4
    1
    Oral candidiasis
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 71 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 71 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Aug 2012
    The reasons for the amendment are as follows: "Risk/Benefit Assessment‟ section amended to include justification of doses, in order to provide information on the reasons for the selection of the proposed doses to be used in the study; Removal of inclusion criterion requiring subjects to have a documented history of airway inflammation indicated by an elevated blood eosinophil count. On review of the literature, the presence of raised levels of eosinophils in the blood was not considered to be an adequate predictor of either airway inflammation or steroid responsive asthma, so this criterion did not offer a useful selection criterion to predict response but would have reduced the eligible population. Addition of acetaminophen as well as paracetamol in concomitant medication list as clinics in the US are taking part in this study; Correction to Figure 1; Correction to in clinic FEV1 withdrawal criterion to ensure consistency with inclusion criteria; Correction to albuterol/salbutamol use withdrawal criterion; Increased number of study sites; Clarification that patients are invited to return to the study clinic for end-of-study assessments; References added to support additional information provided in "Risk/Benefit Assessment‟.
    05 Oct 2012
    To clarify and make consistent information regarding prednisone/prednisolone dose reductions and escalations throughout the protocol and appendices.

    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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