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    Clinical Trial Results:
    A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88 mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months

    Summary
    EudraCT number
    		 2015-004884-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Apr 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2017
    First version publication date
    22 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FAS106533
    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, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jul 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of administration of FP HFA MDI 88 mcg BID on 12 h serum cortisol in pediatric subjects, ages 6 months to <12 months, who have experienced 2 or more wheezing episodes in the preceding 6 months.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Aug 2006
    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 States: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    0
    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)
    23
    Children (2-11 years)
    0
    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
    		 This was an open-label, repeat-dose, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate hydrofluoroalkane (FP HFA) inhalation administered twice-daily, via an metered-dose inhaler (MDI), to participants, aged 6 months to <12 months, who had experienced 2 wheezing episodes in the preceding 6 months.

    Pre-assignment
    Screening details
    		 The study consisted of 2 sessions followed by a follow-up call. The total duration of the study was approximately 8 weeks.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Study
    Arm description
    		 Placebo twice daily (BID) for 14 days followed by FP HFA 44 microgram (mcg) BID for 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone propionate (FP) hydrofluoroalkane (HFA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    This consists of a white to off-white suspension of FP (micronized) in a liquefied HFA propellant. A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both medications, in this case, FP, and a propellant. In Session 2, it was administered at 44 mcg (two inhalations BID given 30 seconds apart for 28 days) using a Aerochamber Plus with an infant mask

    Investigational medicinal product name
    Placebo HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    This consists of a liquefied HFA propellant (placebo). An MDI is a small hand held pressurized canister device that contains both medications, in this case, FP, and a propellant. In Session 1, two inhalations were administered BID 30 seconds apart for 14 days, using a Aerochamber Plus with an infant mask

    Number of subjects in period 1
    		Overall Study
    Started
    23
    Completed Session 1
    21
    Completed
    18
    Not completed
    5
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    1
         Medication not administered
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 In Session 1, participants received two inhalations of placebo HFA BID 30 seconds apart from Day 1 to 14, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask. In Session 2, participants received 2 inhalations of 44 mcg FP HFA BID 30 seconds apart from Day 1 to 28, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask. Doses were given at about the same time of day approximately 12 hours apart.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.4 ( 1.59 ) -
    Gender categorical
    Units:
        Male
    		 18 18
        Female
    		 5 5
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 8 8
        White-Arabic/North African Heritage
    		 1 1
        White-White/Caucasian/European Heritage
    		 12 12
        Mixed Race
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Placebo twice daily (BID) for 14 days followed by FP HFA 44 microgram (mcg) BID for 28 days

    Subject analysis set title
    Placebo HFA
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    In Session 1, participants received two inhalations of placebo HFA BID 30 seconds apart from Day 1 to 14, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask.

    Subject analysis set title
    FP HFA 44 microgram
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    In Session 2, participants received 2 inhalations of 44 mcg FP HFA BID 30 seconds apart from Day 1 to 28, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask. Doses were given at about the same time of day approximately 12 hours apart.

    Primary: Weighted mean serum cortisol over 0 to 12 hours (h) (0-12 h) post dose

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    End point title
    		 Weighted mean serum cortisol over 0 to 12 hours (h) (0-12 h) post dose
    End point description
    Blood samples of participants were collected at the following time points: 0, 2, 4, 8, and 12 hour following the morning dose on Day 14 of Session 1 and Day 28 of Session 2. The primary outcome compared serum cortisol weighted mean(0-12h) between treatments after 28 days of FP HFA MDI 88 mcg with 14 days of placebo, obtained from the repeated measures analysis. . Only those participants available at the specified time points were analyzed. Pharmacodynamic (PD) Population: all participants in the Safety Population (comprised of all participants who received at least one dose of placebo in session 1) who had serum cortisol results for session 1 Day 14 or session 2 Day 28 were included.
    End point type
    Primary
    End point timeframe
    Day 14 and Day 28
    End point values
    		 Placebo HFA FP HFA 44 microgram
    Number of subjects analysed
    21 [1]
    17 [2]
    Units: Nanomoles per liter (nmol/L)
        geometric mean (standard error)
    191.65 ( 0.108 )
    184.58 ( 0.12 )
    Notes
    [1] - PD Population
    [2] - PD Population
    Statistical analysis title
    		 Statistical Analysis - 1
    Comparison groups
    FP HFA 44 microgram v Placebo HFA
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.31
    Notes
    [3] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the ratio of the geometric mean for the two treatment arms was greater than 0.7.

    Secondary: Minimum serum cortisol concentration (Cmin) over 0 to 12 h

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    End point title
    		 Minimum serum cortisol concentration (Cmin) over 0 to 12 h
    End point description
    Blood samples for serum cortisol were collected at the following timepoints: 0, 2, 4, 8, and 12 hour following the morning dose on Day 14 of Session 1 and Day 28 of Session 2. Cmin was derived from the serum cortisol concentration data. Any difference in systemic exposure of the two treatments was considered to also result in differences in serum cortisol concentrations. Only those participants available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 14 and Day 28
    End point values
    		 Placebo HFA FP HFA 44 microgram
    Number of subjects analysed
    17 [4]
    14 [5]
    Units: nmol/L
        geometric mean (confidence interval 95%)
    103.25 (74.47 to 143.15)
    91.56 (64 to 131)
    Notes
    [4] - PD Population
    [5] - PD Population
    Statistical analysis title
    		 Statistical Analysis - 1
    Comparison groups
    Placebo HFA v FP HFA 44 microgram
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.887
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.579
         upper limit
    		 1.359
    Notes
    [6] - Non-inferiority was not demonstrated if the lower confidence limit was greater than 0.7

    Secondary: Maximum plasma concentration at steady-state (Cmax) for FP

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    End point title
    		 Maximum plasma concentration at steady-state (Cmax) for FP
    End point description
    Plasma FP samples were collected at the following times: 1 h post-dose following morning dose on Day 14 (Session 1) and 0, 1, 4, 8 and 12 h post-dose on Day 28 (Session 2) and analyzed for Cmax of FP in the blood. Cmax was used to estimate the time at which the activity of the drug was at its maximum. Pharmacokinetic (PK) Parameter Population: All participants in the PK Concentration Population (included all participants in the Safety Population who had PK results for Session 1 Day 14 or Session 2 Day 28) who had derived PK parameters for session 2 Day 28 were included.
    End point type
    Secondary
    End point timeframe
    Day 14 and Day 28
    End point values
    		 FP HFA 44 microgram
    Number of subjects analysed
    17 [7]
    Units: Picogram/milliliter (pg/mL)
        geometric mean (confidence interval 95%)
    24.6 (13.4 to 45)
    Notes
    [7] - PK Parameter Population
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration versus time curve within a dosing interval at steady-state (AUC[0-t]) for FP

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    End point title
    		 Area under the plasma concentration versus time curve within a dosing interval at steady-state (AUC[0-t]) for FP
    End point description
    Plasma FP samples were collected at the following times: 1 h post-dose following morning dose on Day 14 (Session 1) and 0, 1, 4, 8 and 12 h post-dose on Day 28 (Session 2) and analyzed for AUC(0-t) of FP in the blood. AUC(0-t) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.
    End point type
    Secondary
    End point timeframe
    Day 14 and Day 28
    End point values
    		 FP HFA 44 microgram
    Number of subjects analysed
    17 [8]
    Units: Hours per picogram per milliliter
        geometric mean (confidence interval 95%)
    75 (33.8 to 166.3)
    Notes
    [8] - PK Parameter Population
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration at steady state (tmaxss) for FP

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration at steady state (tmaxss) for FP
    End point description
    Plasma FP samples were collected at the following times: 1 h post-dose following morning dose on Day 14 (Session 1) and 0, 1, 4, 8 and 12 h post-dose on Day 28 (Session 2) and analyzed for tmax of FP in the blood. Tmax is a measure of the time required to reach the maximum concentration of the drug
    End point type
    Secondary
    End point timeframe
    Day 14 and Day 28
    End point values
    		 FP HFA 44 microgram
    Number of subjects analysed
    17 [9]
    Units: Hour (hr)
        median (full range (min-max))
    1 (0 to 4)
    Notes
    [9] - PK parameter population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse events (AEs) and any serious averse events (SAE) during the treatment period

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    End point title
    		 Number of participants with any adverse events (AEs) and any serious averse events (SAE) during the treatment period
    End point description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and is a significant medical event in the investigator's judgment. Safety Population: all participants who received at least one dose of placebo in session 1.
    End point type
    Secondary
    End point timeframe
    Up to 4 weeks
    End point values
    		 Placebo HFA FP HFA 44 microgram
    Number of subjects analysed
    23 [10]
    21 [11]
    Units: Participants
    number (not applicable)
        Any AE
    22
    19
        Any SAE
    1
    0
    Notes
    [10] - Safety Population
    [11] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected from the time a parent/guardian consents for their infant to participate in the study to the end of the the treatment period (approximately 8 weeks including screening and follow-up).
    Adverse event reporting additional description
    SAEs and non-serious AEs were reported for the Safety Population, comprised all participants who received at least one dose of placebo in session 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Fluticasone propionate HFA
    Reporting group description
    		 In Session 2, participants received 2 inhalations of 44 mcg FP HFA BID 30 seconds apart from Day 1 to 28, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask. Doses were given at about the same time of day approximately 12 hours apart.

    Reporting group title
    Placebo HFA
    Reporting group description
    		 In Session 1, participants received two inhalations of placebo HFA BID 30 seconds apart from Day 1 to 14, via a MDI and a valved holding chamber (AeroChamber Plus) with infant mask.

    Serious adverse events
    		 Fluticasone propionate HFA Placebo HFA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluticasone propionate HFA Placebo HFA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 21 (90.48%)
    22 / 23 (95.65%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 21 (28.57%)
    8 / 23 (34.78%)
         occurrences all number
    10
    11
    Irritability
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Teething
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 23 (4.35%)
         occurrences all number
    4
    1
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 21 (66.67%)
    17 / 23 (73.91%)
         occurrences all number
    32
    58
    Rhinorrhoea
         subjects affected / exposed
    13 / 21 (61.90%)
    15 / 23 (65.22%)
         occurrences all number
    23
    25
    Nasal congestion
         subjects affected / exposed
    6 / 21 (28.57%)
    12 / 23 (52.17%)
         occurrences all number
    12
    16
    Wheezing
         subjects affected / exposed
    8 / 21 (38.10%)
    10 / 23 (43.48%)
         occurrences all number
    22
    26
    Dyspnoea
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    Respiratory tract congestion
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Grunting
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Sneezing
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Middle insomnia
         subjects affected / exposed
    11 / 21 (52.38%)
    9 / 23 (39.13%)
         occurrences all number
    17
    27
    Crying
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Ear infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Eye infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2006
    The purpose of this amendment is to make changes to the Rationale, Endpoints, Hypotheses, Study Design, Dose Rationale and Sample Size Assumptions sections of the protocol as well as include additional information to the Background Section of the protocol and remove section 10.2.2 which no longer applies to this protocol

    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
    For support, Contact us.
    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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