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    Clinical Trial Results:
    A randomised, double-blind, two-way crossover study to investigate the effect of inhaled fluticasone furoate on short-term growth in paediatric subjects with asthma

    Summary
    EudraCT number
    		 2015-000841-22
    Trial protocol
    		 DK  
    Global end of trial date
    21 Dec 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HZA107112
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1-866 +4357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1-866 +4357343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000431-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of two weeks treatment with inhaled fluticasone furoate versus placebo once daily on short-term lower-leg growth using a knemometer.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 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
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    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
    		 Study consisted of run-in period of two-weeks followed by two treatment periods of 14 days each (+/- 4 days) separated by a 14-day washout period and a follow-up visit of approximately 7 days post last dose. The total participation time in the study was approximately 9 Weeks.

    Pre-assignment
    Screening details
    		 A total of 60 participants were randomized to receive one of the two treatment sequences; placebo followed by inhaled fluticasone furoate or inhaled fluticasone furoate followed by placebo. All 60 participants received at least one single dose of study medication.

    Period 1
    Period 1 title
    Double-blind treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo followed by fluticasone furoate
    Arm description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Arm title
    		 Fluticasone furoate followed by placebo
    Arm description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Number of subjects in period 1
    		Placebo followed by fluticasone furoate Fluticasone furoate followed by placebo
    Started
    30
    30
    Completed
    29
    30
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Period 2
    Period 2 title
    Washout Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Monitor, Subject, Investigator, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo followed by fluticasone furoate
    Arm description
    		 The two treatment periods were separated by a two-week wash-out period in which all participants did not receive study medication, but were provided a salbutamol inhaler for symptomatic relief of asthma symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Arm title
    		 Fluticasone furoate followed by placebo
    Arm description
    		 The two treatment periods were separated by a two-week wash-out period in which all participants did not receive study medication, but were provided a salbutamol inhaler for symptomatic relief of asthma symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Number of subjects in period 2
    		Placebo followed by fluticasone furoate Fluticasone furoate followed by placebo
    Started
    29
    30
    Completed
    28
    30
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Period 3
    Period 3 title
    Double-blind treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo followed by fluticasone furoate
    Arm description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Arm title
    		 Fluticasone furoate followed by placebo
    Arm description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Investigational medicinal product name
    Fluticasone furoate 50 mcg Dry Powder Inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fluticasone furoate 50 mcg was administered once daily (OD) for 14 days +/- 4 days. Each dose was administered via dry powder inhaler.

    Number of subjects in period 3
    		Placebo followed by fluticasone furoate Fluticasone furoate followed by placebo
    Started
    28
    30
    Completed
    28
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-blind treatment Period 1
    Reporting group description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.

    Reporting group values
    		 Double-blind treatment Period 1 Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.7 ( 1.53 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 36 36
    Race, Customized
    Units: Subjects
        Asian - Central/South Asian Heritage
    		 1 1
        White - White/Caucasian/European Heritage
    		 59 59

    End points

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    End points reporting groups
    Reporting group title
    Placebo followed by fluticasone furoate
    Reporting group description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.

    Reporting group title
    Fluticasone furoate followed by placebo
    Reporting group description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
    Reporting group title
    Placebo followed by fluticasone furoate
    Reporting group description
    		 The two treatment periods were separated by a two-week wash-out period in which all participants did not receive study medication, but were provided a salbutamol inhaler for symptomatic relief of asthma symptoms.

    Reporting group title
    Fluticasone furoate followed by placebo
    Reporting group description
    		 The two treatment periods were separated by a two-week wash-out period in which all participants did not receive study medication, but were provided a salbutamol inhaler for symptomatic relief of asthma symptoms.
    Reporting group title
    Placebo followed by fluticasone furoate
    Reporting group description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.

    Reporting group title
    Fluticasone furoate followed by placebo
    Reporting group description
    		 Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2

    Subject analysis set title
    Fluticasone furoate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2

    Primary: Mean growth rate in lower-leg growth (mm/week), as determined by knemometry

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    End point title
    		 Mean growth rate in lower-leg growth (mm/week), as determined by knemometry
    End point description
    Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week treatment period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively
    End point values
    		 Placebo Fluticasone furoate
    Number of subjects analysed
    58 [1]
    58 [2]
    Units: millimeter per week
        least squares mean (standard error)
    0.3638 ( 0.02793 )
    0.3118 ( 0.02793 )
    Notes
    [1] - Growth Population
    [2] - Growth Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period. Please note: To clarify system limitations, the comparison groups for statistical analysis are fluticasone furoate vs. placebo. Although the system adds the subjects in each analysis group together (total 116 below), there are only 58 subjects measured in this analysis as this is a crossover study with the same 58 subjects in each arm.
    Comparison groups
    Fluticasone furoate v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.052
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1217
         upper limit
    		 0.0176
    Notes
    [3] - Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.

    Secondary: Number of participants with any adverse events (AE) and any serious adverse event (SAE).

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    End point title
    		 Number of participants with any adverse events (AE) and any serious adverse event (SAE).
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until follow-up (assessed up to 54 days)
    End point values
    		 Placebo Fluticasone furoate
    Number of subjects analysed
    60 [4]
    58 [5]
    Units: Participants
    14
    7
    Notes
    [4] - ITT Population
    [5] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
    Adverse event reporting additional description
    On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2

    Reporting group title
    Fluticasone furoate
    Reporting group description
    		 Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2

    Serious adverse events
    		 Placebo Fluticasone furoate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Fluticasone furoate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 60 (25.00%)
    7 / 58 (12.07%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 60 (13.33%)
    3 / 58 (5.17%)
         occurrences all number
    9
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Oropharyngeal pain
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 60 (8.33%)
    4 / 58 (6.90%)
         occurrences all number
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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