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    Clinical Trial Results:
    A double-blind, double dummy, randomised, parallel group, multicentre study to compare the efficacy and safety of Flutiform pMDI with fluticasone pMDI and with Seretide pMDI in paediatric subjects aged 5 to less than 12 years with moderate to severe persistent reversible asthma.

    Summary
    EudraCT number
    		 2010-024635-16
    Trial protocol
    		 HU   CZ   PL   BG  
    Global end of trial date
    04 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FLT3506
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01511367
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mundipharma Research Ltd.
    Sponsor organisation address
    Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW
    Public contact
    European Medical Operations, Mundipharma Research Limited, +44 1223424900, info@contact-clinical-trials.com
    Scientific contact
    European Medical Operations, Mundipharma Research Limited, +44 1223424900, info@contact-clinical-trials.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000127-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).
    Protection of trial subjects
    All subjects and their guardians/legally authorised representatives were provided with oral and written information describing the nature and duration of the study, its purpose, the procedures to be performed, the potential risks and benefits involved, and any potential discomfort. Each subject was given a copy of the PIS and ICF. The subject’s guardian /legally authorised representative was asked to sign an informed consent form and, according to local country requirements and where appropriate, the subject was asked to sign/mark (e,g. drawing if subject was very young) an informed assent form (IAF) prior to any study-specific procedures being performed. No subject could enter the study before his/her guardian’s/legally authorised representative’s informed consent had been obtained.
    Background therapy
    		 Salbutamol 100 µg was used as rescue medication in the run-in and treatment period.
    Evidence for comparator
    		 Seretide was chosen as a comparator product because it is a marketed asthma medication consisting of an ICS and a LABA within a pMDI. The choice of Seretide (in some countries known as Viani® or Advair®) also maintains consistency across the treatment for the steroid part of the combinations (fluticasone). Seretide is a market leader within the field of asthma and is licensed for use in children aged 4 years or older.
    Actual start date of recruitment
    26 Mar 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
    Bulgaria: 90
    Country: Number of subjects enrolled
    Poland: 187
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Hungary: 107
    Country: Number of subjects enrolled
    India: 10
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Russian Federation: 72
    Country: Number of subjects enrolled
    Ukraine: 29
    Worldwide total number of subjects
    512
    EEA total number of subjects
    401
    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)
    512
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 713 subjects provided written informed consent and were screened; 512 subjects were randomised and 509 subjects were treated. 150 subjects failed screening; 136 subjects due to failing the inclusion/exclusion criteria, 11 subjects chose not to continue, 2 subjects due to adverse event, and 1 subject due to administrative reasons.

    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, Carer, Assessor
    Blinding implementation details
    The subject and all personnel involved with the study, excluding those involved in processing and regulatory reporting of SUSARs, were blinded to the medication codes. The randomisation schedule was filed securely by the interactive response technology (IRT) provider in a manner such that blinding was properly maintained throughout the study. To maintain the blinded nature of this study, each subject received 2 inhalers.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Flutiform
    Arm description
    		 Flutiform
    Arm type
    		 Experimental

    Investigational medicinal product name
    Flutiform
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50/5µg, 2 puffs, Q12h

    Arm title
    		 Fluticasone
    Arm description
    		 Fluticasone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone
    Investigational medicinal product code
    Other name
    Fluticasone propionate
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50 µg, 2 puffs, Q12h

    Arm title
    		 Seretide
    Arm description
    		 Seretide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    50/25 µg, 2 puffs, Q12h

    Number of subjects in period 1
    		Flutiform Fluticasone Seretide
    Started
    169
    173
    170
    Run-in
    169
    173
    170
    Treatment period
    169
    173
    170
    Completed
    161
    161
    159
    Not completed
    8
    12
    11
         Consent withdrawn by subject
    1
    1
    -
         Administrative
    4
    7
    5
         Adverse event, non-fatal
    -
    1
    -
         Lack of efficacy
    3
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flutiform
    Reporting group description
    		 Flutiform

    Reporting group title
    Fluticasone
    Reporting group description
    		 Fluticasone

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide

    Reporting group values
    		 Flutiform Fluticasone Seretide Total
    Number of subjects
    		 169 173 170 512
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Children (5-11 years)
    		 169 173 170 512
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 58 55 56 169
        Male
    		 111 118 114 343
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population (SP) was defined as all randomised subjects who received at least one dose of study medication (IMP). Subjects were analysed according to actual treatment received.

    Subject analysis set title
    Full Analysis Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis population (FAP) was defined as all randomised subjects who received at least one dose of study medication (IMP) and had at least one valid efficacy (FEV1) assessment. Subjects will be analysed according to their randomised treatment.

    Subject analysis sets values
    		 Safety Population Full Analysis Population
    Number of subjects
    509
    506
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Children (5-11 years)
    509
    506
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    168
    168
        Male
    341
    338

    End points

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    End points reporting groups
    Reporting group title
    Flutiform
    Reporting group description
    		 Flutiform

    Reporting group title
    Fluticasone
    Reporting group description
    		 Fluticasone

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population (SP) was defined as all randomised subjects who received at least one dose of study medication (IMP). Subjects were analysed according to actual treatment received.

    Subject analysis set title
    Full Analysis Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis population (FAP) was defined as all randomised subjects who received at least one dose of study medication (IMP) and had at least one valid efficacy (FEV1) assessment. Subjects will be analysed according to their randomised treatment.

    Primary: Change from pre-dose FEV1 at baseline to the 2-hour post-dose FEV1 over the 12 week treatment period

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    End point title
    		 Change from pre-dose FEV1 at baseline to the 2-hour post-dose FEV1 over the 12 week treatment period
    End point description
    The primary endpoint, which was tested in a hierarchical (gate keeping) manner for the two study comparisons (Flutiform to Fluticasone, then Flutiform to Seretide), was the change from pre-dose Forced Expiratory Volume in 1 second (FEV1) at baseline to 2 hours post-dose FEV1 over the 12 week treatment period.
    End point type
    Primary
    End point timeframe
    From baseline to the 2-hour post-dose values over the 12 weeks.
    End point values
    		 Flutiform Fluticasone Seretide
    Number of subjects analysed
    165
    165
    165
    Units: Litres
        least squares mean (confidence interval 95%)
    0.22 (0.18 to 0.26)
    0.15 (0.11 to 0.19)
    0.22 (0.18 to 0.26)
    Statistical analysis title
    		 Superiority of Flutiform versus Fluticasone
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform = μ Fluticasone Alternative (H1): μ Flutiform ≠ μ Fluticasone The change from pre-dose FEV1 values at baseline to the 2-hour post dose FEV1 values at each post baseline visit were analysed using a repeated measures Analysis of Covariance (ANCOVA) with fixed terms for treatment, age group, pre-dose FEV1 at baseline, visit and treatment by visit interaction, and centre as a random effect.
    Comparison groups
    Flutiform v Fluticasone
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Superiority was demonstrated if the primary comparison of Flutiform versus Fluticasone was significant at the 0.05 alpha level.
    [2] - Based on the null hypothesis that there is no difference in treatment means.
    Statistical analysis title
    		 Non-inferiority of Flutiform versus Seretide
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform - μ Seretide < - 0.1 Alternative (H1): μ Flutiform - μ Seretide ≥ - 0.1 The change from pre-dose FEV1 values was analysed using a repeated measures ANCOVA with fixed terms for treatment, age group, pre-dose FEV1 at baseline, visit and treatment by visit interaction and centre as a random effect. The statistical model was used to calculate the overall treatment difference and 95% CI.
    Comparison groups
    Flutiform v Seretide
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - Non-inferiority was concluded if the lower limit of the 95% (confidence interval) CI was greater than or equal to -0.1L and the p-value for the non-inferiority comparison was based on a treatment difference of -0.1L.
    [4] - P-value of the pairwise treatment comparisons (based on the null hypothesis that the difference in treatment means is -0.1L).

    Secondary: FEV1 AUC0-4h at Week 12

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    End point title
    		 FEV1 AUC0-4h at Week 12
    End point description
    Normalised four hour FEV1 area under the curve values at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Flutiform Fluticasone Seretide
    Number of subjects analysed
    149
    147
    152
    Units: Litres/hour
        least squares mean (confidence interval 95%)
    1.8 (1.75 to 1.84)
    1.71 (1.66 to 1.76)
    1.79 (1.74 to 1.83)
    Statistical analysis title
    		 Superiority of Flutiform versus Fluticasone
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform = μ Fluticasone Alternative (H1): μ Flutiform ≠ μ Fluticasone The normalised 4-hour FEV1 AUC0-4h values at Week 12 were analysed using an ANCOVA with fixed terms for treatment, age group, pre-dose FEV1 at baseline, and centre as a random effect.
    Comparison groups
    Flutiform v Fluticasone
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - Superiority was demonstrated if the primary comparison of Flutiform versus Fluticasone was significant at the 0.05 alpha level.
    [6] - P-value of the pairwise treatment comparisons (based on the null hypothesis that there is no difference in treatment means).
    Statistical analysis title
    		 Non-inferiority of Flutiform versus Seretide
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform - μ Seretide < - 0.1 Alternative (H1): μ Flutiform - μ Seretide ≥ - 0.1 The change from pre-dose FEV1 values from baseline to each post baseline visit over the 12 weeks was analysed using a repeated measures ANCOVA with fixed terms for treatment, age group, pre-dose FEV1 at baseline, visit and treatment by visit interaction and centre as a random effect.
    Comparison groups
    Flutiform v Seretide
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - Non-inferiority was concluded if the lower limit of the 95% (confidence interval) CI was greater than or equal to -0.1L. The statistical model was used to calculate the overall treatment difference and 95% CI.
    [8] - P-value of the pairwise treatment comparisons (based on the null hypothesis that the difference in treatment means is -0.1L).

    Secondary: Change from pre-dose FEV1 at baseline over the 12 week treatment period

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    End point title
    		 Change from pre-dose FEV1 at baseline over the 12 week treatment period
    End point description
    Change from pre-dose Forced Expiratory Volume in 1 second (FEV1) from baseline over the 12 week treatment period.
    End point type
    Secondary
    End point timeframe
    From baseline to each post baseline visit over 12 weeks.
    End point values
    		 Flutiform Fluticasone Seretide
    Number of subjects analysed
    166
    171
    165
    Units: Litres
        least squares mean (confidence interval 95%)
    0.13 (0.09 to 0.17)
    0.1 (0.06 to 0.14)
    0.16 (0.12 to 0.2)
    Statistical analysis title
    		 Superiority of Flutiform versus Fluticasone
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform = μ Fluticasone Alternative (H1): μ Flutiform ≠ μ Fluticasone The change from pre-dose FEV1 values from baseline to each post baseline visit over 12 weeks was analysed using a repeated measures ANCOVA with fixed terms for treatment, age group, pre-dose FEV1 at baseline, visit and treatment by visit interaction, and centre as a random effect. The statistical model was used to calculate the overall treatment difference and 95% CI.
    Comparison groups
    Fluticasone v Flutiform
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.091 [10]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [9] - Superiority was demonstrated if the primary comparison of Flutiform versus Fluticasone was significant at the 0.05 alpha level.
    [10] - P-value of the pairwise treatment comparisons (based on the null hypothesis that there is no difference in treatment means).
    Statistical analysis title
    		 Non-inferiority of Flutiform versus Seretide
    Statistical analysis description
    Null hypothesis (H0): μ Flutiform - μ Seretide < - 0.1 Alternative (H1): μ Flutiform - μ Seretide ≥ - 0.1 The change from pre-dose FEV1 values from baseline to each post baseline visit over 12 weeks was analysed using a repeated measures ANCOVA with fixed terms for treatment, age group, pre-dose FEV1 at baseline, visit and treatment by visit interaction and centre as a random effect.
    Comparison groups
    Flutiform v Fluticasone v Seretide
    Number of subjects included in analysis
    502
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    P-value
    		 < 0.001 [12]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [11] - Non-inferiority was concluded if the lower limit of the 95% (confidence interval) CI was greater than or equal to -0.1L and the p-value for the non-inferiority comparison was based on a treatment difference of -0.1L.
    [12] - P-value of the pairwise treatment comparisons (based on the null hypothesis that the difference in treatment means is -0.1L).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were recorded from the point at which the Informed Consent was signed until 14 days after the subject left the study. This included new AEs that were reported in the 14 days following the subject’s completion/discontinuation visit.
    Adverse event reporting additional description
    Only treatment emergent AEs were summarised. A treatment emergent AE was defined as any AE with an onset date on or after the first dose of study medication if the AE was absent before the first dose of study medication, or worsened after the first dose of study medication.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Flutiform
    Reporting group description
    		 Flutiform

    Reporting group title
    Fluticasone
    Reporting group description
    		 Fluticasone

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide

    Serious adverse events
    		 Flutiform Fluticasone Seretide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 172 (0.58%)
    0 / 169 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 172 (0.58%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 172 (0.00%)
    0 / 169 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Flutiform Fluticasone Seretide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 168 (22.62%)
    52 / 172 (30.23%)
    35 / 169 (20.71%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 168 (1.19%)
    4 / 172 (2.33%)
    2 / 169 (1.18%)
         occurrences all number
    3
    4
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 168 (1.79%)
    2 / 172 (1.16%)
    4 / 169 (2.37%)
         occurrences all number
    3
    2
    5
    Nasopharyngitis
         subjects affected / exposed
    4 / 168 (2.38%)
    15 / 172 (8.72%)
    13 / 169 (7.69%)
         occurrences all number
    4
    20
    14
    Pharyngitis
         subjects affected / exposed
    4 / 168 (2.38%)
    7 / 172 (4.07%)
    4 / 169 (2.37%)
         occurrences all number
    6
    8
    4
    Rhinitis
         subjects affected / exposed
    8 / 168 (4.76%)
    4 / 172 (2.33%)
    4 / 169 (2.37%)
         occurrences all number
    11
    4
    6
    Viral rhinitis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 172 (1.16%)
    4 / 169 (2.37%)
         occurrences all number
    1
    2
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2013
    Protocol Amendment No. 3 was a substantial amendment which revised the study objectives and amended the statistical analysis accordingly following Scientific advice from the MHRA. The approved indication for Flutiform in adults and adolescents includes a “switch” to Flutiform in patients already adequately controlled on a combination of an inhaled corticosteroid and a long-acting β2 agonist. In the light of this indication, at a scientific advice meeting on the 27th February 2013, the MHRA advised the sponsor to revise the paediatric study objectives and to designate non-inferiority versus Seretide as a key secondary objective. Although the Paediatric Development Committee (PDCO) had already endorsed the design and comparisons in the original study, in order to accommodate the MHRA’s recommendation the sponsor altered the designation of comparators accordingly and amended the original sequence of statistical tests in order to control the Type 1 error rate. Furthermore given the confirmatory nature of the comparison versus Seretide in the amended protocol the primary timepoint for this comparison was revised.

    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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