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    Clinical Trial Results:
    An Open-Label, Multi-Centre, Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of 2-Week Treatment with Inhaled AZD7594 in Adolescents (12 to 17 years) with Asthma

    Summary
    EudraCT number
    		 2019-001259-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2020
    First version publication date
    31 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3741C00012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03976869
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Not applicable, Sodertalje, Sweden, SE-151 85
    Public contact
    Clinical Study Information Center, AstraZeneca, US 1 877 240 9479, Information.Center@astrazeneca.com
    Scientific contact
    Clinical Study Information Center, AstraZeneca, US 1 877 240 9479, Information.Center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001976-PIP02-18
    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
    11 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective of the study was to assess the pharmacokinetic (PK) profile of velsecorat (AZD7594) at steady state in adolescent subjects with asthma.
    Protection of trial subjects
    The study protocol and all protocol amendments, all versions of the informed consent form (ICFs) and any other written information and/or materials provided to the subjects were submitted to an institutional review board (IRB) by the Investigator and approved by an IRB in writing before the study was initiated. This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/ Good Clinical Practice (GCP), applicable regulatory requirements and the AstraZeneca policy on Bioethics. The Principal Investigator (PI) at each site ensured that subjects and their legally authorised representative, defined are their parents/legal guardians (caregiver), were given full and adequate oral and written information about the nature, purpose, possible benefit and risk of the study. The PI also notified subjects and caregivers that they were free to withdraw from the study at any time. The PI gave the subjects and caregivers the opportunity to ask questions and time to consider the information provided. Subjects and their legally authorised representatives were required to sign a statement of assent or informed consent, respectively, that met the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act requirements, where applicable, and the IRB or study centre.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2019
    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: 36
    Worldwide total number of subjects
    36
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    36
    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
    		 The study was conducted in 10 centres across United States from 24-Jul-2019 to 9-Jul-2020.

    Pre-assignment
    Screening details
    		 Total 59 subjects were screened, 12 subjects were screen failed before entering the wash-out period and 11 subjects were screen failed after having entered the wash-out period. Finally 36 subjects entered the Treatment period and received velsecorat.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 12-14 years
    Arm description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velsecorat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    Oral inhalation of velsecorat (360 µg [delivered dose], via dry powder inhaler [DPI]) once daily multiple-dose for 15 to 16 days. One inhalation per day at the same time (±30 minutes) every day.

    Arm title
    		 15-17 years
    Arm description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via DPI) once daily for 15 to 16 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velsecorat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    Oral inhalation of velsecorat (360 µg [delivered dose], via DPI) once daily multiple-dose for 15 to 16 days. One inhalation per day at the same time (±30 minutes) every day.

    Number of subjects in period 1
    		12-14 years 15-17 years
    Started
    20
    16
    Completed
    19
    15
    Not completed
    1
    1
         Lost to follow-up
    1
    -
         Withdrawal by parent/guardian
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    12-14 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.

    Reporting group title
    15-17 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via DPI) once daily for 15 to 16 days.

    Reporting group values
    		 12-14 years 15-17 years Total
    Number of subjects
    		 20 16 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-14 years)
    		 20 0 20
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adolescents (15-17 years)
    		 0 16 16
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 12.8 ± 0.77 15.9 ± 0.77 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 11 8 19
        Male
    		 9 8 17
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 5 5 10
        White
    		 12 11 23
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 10 4 14
        Not Hispanic or Latino
    		 10 12 22
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    12-14 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.

    Reporting group title
    15-17 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via DPI) once daily for 15 to 16 days.

    Primary: Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15

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    End point title
    		 Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15 [1]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    16
    11
    Units: pmol/L
        geometric mean (geometric coefficient of variation)
    95.13 ± 80.7
    155.8 ± 76.4
    No statistical analyses for this end point

    Primary: Minimum observed plasma concentration at steady state within 0 to 12 hours (Cmin,ss) at Day 15

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    End point title
    		 Minimum observed plasma concentration at steady state within 0 to 12 hours (Cmin,ss) at Day 15 [2]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    15
    11
    Units: pmol/L
        geometric mean (geometric coefficient of variation)
    46.79 ± 63.4
    77.61 ± 70.8
    No statistical analyses for this end point

    Primary: Observed trough plasma concentration at end of dosing interval (τ) (Ctrough) at Day 15

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    End point title
    		 Observed trough plasma concentration at end of dosing interval (τ) (Ctrough) at Day 15 [3]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    15
    11
    Units: pmol/L
        geometric mean (geometric coefficient of variation)
    50.33 ± 73.6
    72.77 ± 65.0
    No statistical analyses for this end point

    Primary: Time of maximum observed plasma concentration at steady state (tmax,ss) at Day 15

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    End point title
    		 Time of maximum observed plasma concentration at steady state (tmax,ss) at Day 15 [4]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    16
    11
    Units: Hours
        median (full range (min-max))
    0.25 (0.23 to 3.10)
    0.50 (0.08 to 4.00)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve over a dosing interval (τ) at steady state (AUCτ) at Day 15

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    End point title
    		 Area under the plasma concentration-time curve over a dosing interval (τ) at steady state (AUCτ) at Day 15 [5]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    15
    11
    Units: h*pmol/L
        geometric mean (geometric coefficient of variation)
    1204 ± 76.8
    2131 ± 67.8
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC0-12) at Day 15

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    End point title
    		 Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC0-12) at Day 15 [6]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    15
    11
    Units: h*pmol/L
        geometric mean (geometric coefficient of variation)
    733.6 ± 69.3
    1218 ± 70.7
    No statistical analyses for this end point

    Primary: Apparent total body clearance after extravascular administration at steady state (CLss/F) at Day 15

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    End point title
    		 Apparent total body clearance after extravascular administration at steady state (CLss/F) at Day 15 [7]
    End point description
    To assess the PK profile of velsecorat at steady state following daily inhalations for 2 weeks in adolescent subjects with asthma. The PK analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of study drug and for whom at least 1 of the primary PK parameters was calculated, and who had no major protocol deviations considered to impact on the analysis of the PK data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Primary
    End point timeframe
    Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was available for this end point.
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    15
    11
    Units: Liter/hours
        geometric mean (geometric coefficient of variation)
    493.0 ± 76.8
    278.5 ± 67.8
    No statistical analyses for this end point

    Secondary: Area under the plasma cortisol concentration-time curve from 0 to 12 hours (AUEC0-12)

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    End point title
    		 Area under the plasma cortisol concentration-time curve from 0 to 12 hours (AUEC0-12)
    End point description
    To evaluate the pharmacodynamic (PD) of velsecorat following daily inhalations for 2 weeks in adolescent subjects with asthma. Baseline plasma cortisol concentration was determined during the washout period within 1-7 days before the first dose of study treatment. Change from baseline was calculated as the differences between the post-dose value at each time-point and baseline. The PD analysis set was used to evaluate this endpoint, which included all subjects for whom plasma cortisol AUEC0-12 was calculated at baseline and post-baseline, and who had no major protocol deviations considered to impact on the analysis of the PD data (e.g., disallowed medication, poor treatment compliance).
    End point type
    Secondary
    End point timeframe
    Pre-dose (baseline) and 2, 4, 6, 8, 12 hours post-dose at Day 15
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    16
    12
    Units: h*ng/mL
        geometric mean (geometric coefficient of variation)
    602.7 ± 45.0
    891.4 ± 49.0
    Statistical analysis title
    		 Plasma cortisol level on Day 15
    Statistical analysis description
    Relative change from baseline
    Comparison groups
    12-14 years v 15-17 years
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Geometric least squares mean
    Point estimate
    0.92
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [8] - Statistical analyses of the change from baseline in plasma cortisol level on Day 15. Analyses were based on an analysis of covariance (ANCOVA) model with age group as fixed effect, and log-transformed baseline value as a covariate.

    Secondary: Change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15

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    End point title
    		 Change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15
    End point description
    To evaluate the PD of velsecorat following daily inhalations for 2 weeks in adolescent subjects with asthma. Baseline was defined as the mean of the two measured values before first study drug administration (-45 minutes and -15 minutes) on Day 1 and trough value was defined as the mean of the two measurements 30 minutes apart (23 hours after last dose) pre-dose on Day 15. This could be performed either at home (or other safe location of the subject’s choice) or at the study site. Safety analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of velsecorat.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) and at Day 15 (pre-dose)
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    16
    15
    Units: Liter
        arithmetic mean (standard deviation)
    0.0388 ± 0.2069
    -0.1346 ± 0.5038
    Statistical analysis title
    		 FEV1 on Day 15
    Statistical analysis description
    Change from baseline
    Comparison groups
    12-14 years v 15-17 years
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 Least squares mean
    Point estimate
    -0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [9] - Statistical analyses of the change from baseline in morning trough FEV1 on Day 15. Analyses were based on ANCOVA model with age group as fixed effect, and baseline value as a covariate.

    Secondary: Change from baseline in asthma control questionnaire (ACQ-5) on Day 15

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    End point title
    		 Change from baseline in asthma control questionnaire (ACQ-5) on Day 15
    End point description
    To evaluate the PD of velsecorat following daily inhalations for 2 weeks in adolescent subjects with asthma. Baseline and Day 15 ACQ-5 scores were defined as the mean of the five question responses collected before velsecorat administration at each of Day 1 and Day 15, respectively. Change from baseline was defined as the Day 15 score minus baseline score. The validated ACQ-5 measures both the adequacy of asthma control and changes in asthma control. The questionnaire had 5 items; each item is scored on a scale of 0 to 6, where lower scores corresponds better asthma control and higher scores represents more severe impairment/symptoms. Safety analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of velsecorat.
    End point type
    Secondary
    End point timeframe
    At Day 15
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    19
    15
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.23 ± 0.637
    -0.20 ± 0.994
    Statistical analysis title
    		 ACQ-5 score on Day 15
    Statistical analysis description
    Change from baseline
    Comparison groups
    12-14 years v 15-17 years
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    Parameter type
    		 Least squares mean
    Point estimate
    -0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [10] - Statistical analyses of the change from baseline in ACQ-5 score on Day 15. Information regarding safety analysis sin second sentence. Analyses are based on ANCOVA model with age group as fixed effect, and baseline value as a covariate.

    Secondary: Number of subjects with adverse events (AEs)

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    End point title
    		 Number of subjects with adverse events (AEs)
    End point description
    To evaluate the tolerability and safety of inhaled velsecorat. Safety analysis set was used to evaluate this endpoint, which included all subjects who took at least 1 dose of velsecorat.
    End point type
    Secondary
    End point timeframe
    Day 1 until follow-up (7-14 days)
    End point values
    		 12-14 years 15-17 years
    Number of subjects analysed
    20
    16
    Units: Subjects
        Any AE
    1
    3
        Any AE with outcome of Death
    0
    0
        Any serious adverse event
    0
    0
        Any AE leading to discontinuation of study drug
    0
    0
        Any AE leading to withdrawal from study
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 until follow-up (7-14 days)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    15-17 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via DPI) once daily for 15 to 16 days.

    Reporting group title
    12-14 years
    Reporting group description
    		 Subjects received oral inhalation of velsecorat (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.

    Serious adverse events
    		 15-17 years 12-14 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 15-17 years 12-14 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 20 (5.00%)
    Injury, poisoning and procedural complications
    Muscle injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 20 (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
    30 Oct 2019
    Inclusion criteria #3 and #7 updated to clarify that asthma treatment may be daily or intermittently, and to adjust the body mass index inclusion restriction to above the 5th percentile rather than within the 5th and 95th percentile. and exclusion criteria #1, #3 and #4 were updated to exclude subjects with severe obesity including weight-related health problems, and to extend ECG screening exclusion criteria from Visit 1 to Visit 1 or pre-dose Visit 4.
    22 Apr 2020
    Removal of reversibility criteria. Deletion of Visit 2. A window of +10 minutes added for the 30-minute post-dose ECG only. Text added allowing subjects to choose an alternate safe location for home nursing visits. Inclusion criterion #3 updated and included that the subject must have used the monotherapy at least once in the 3 months prior to screening. Screen failures section revised to allow re-screening of screen failure subjects due to not meeting reversibility criteria. Section of sample size determination was revised to increase the flexibility, that 24 eligible subjects should include 11 to 13 subjects in each age group was removed. Addition that ECG collection timing was to occur prior to vital signs when these assessments were performed at the same time. Requirement that the 24 eligible subjects should include 11 to 13 subjects in each age group was removed. Changes made to clarify PK and PD set.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Mar 2020
    Due to the COVID-19 pandemic further screening was paused in the trial, while ongoing subjects were allowed to continue until study completion. Based on velsecorat safety profile and the mild asthmatic subject population it was deemed safe to re-start screening again on 23-Apr-2020.
    23 Apr 2020

    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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