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    Clinical Trial Results:
    An open-label, two-period, single-sequence, crossover study to compare the systemic exposure of a single inhaled dose of mometasone furoate (MF) when administered alone via the MF Twisthaler® (TH) to a single inhaled dose of QMF149 indacaterol acetate/MF fixed dose combination when administered via the Concept 1 (C1) Breezhaler® device in ≥ 6 to < 12 year old asthma patients

    Summary
    EudraCT number
    		 2020-002036-78
    Trial protocol
    		 HU  
    Global end of trial date
    11 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Sep 2022
    First version publication date
    29 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQMF149G2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04589663
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharmaceuticals, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Study Director, Novartis Pharmaceuticals, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the systemic exposure of MF resulting from single orally-inhaled doses of MF when administered as MF TH 100 μg versus QMF149 75/40 μg C1.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2021
    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
    Hungary: 7
    Country: Number of subjects enrolled
    South Africa: 17
    Worldwide total number of subjects
    24
    EEA total number of subjects
    7
    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)
    24
    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
    		 Participants were recruited from 3 sites in 2 countries

    Pre-assignment
    Screening details
    		 Participants underwent a Screening period of up to 14 days

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

    Arms
    Arm title
    		 MF followed by QMF149
    Arm description
    		 Single inhaled dose of mometasone furoate on Day 1 delivered via TH inhaler followed by 4-7 days of washout. On Day 6-9, single inhaled dose of QMF149 delivered via C1 inhaler.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single inhaled dose of 100 µg mometasone furoate (MF) administered via Twisthaler® on Day 1

    Investigational medicinal product name
    Standard of Care (Soc)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Asthma therapy: budesonide and salbutamol being the most frequently used (excluding MF and indacaterol acetate)

    Investigational medicinal product name
    QMF149
    Investigational medicinal product code
    QMF149
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6-9

    Number of subjects in period 1
    		MF followed by QMF149
    Started
    24
    Completed
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MF followed by QMF149
    Reporting group description
    		 Single inhaled dose of mometasone furoate on Day 1 delivered via TH inhaler followed by 4-7 days of washout. On Day 6-9, single inhaled dose of QMF149 delivered via C1 inhaler.

    Reporting group values
    		 MF followed by QMF149 Total
    Number of subjects
    		 24 24
    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)
    		 24 24
        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: Years
        arithmetic mean (standard deviation)
    		 9.0 ( 1.46 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 6 6
        Male
    		 18 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 1 1
        White
    		 8 8
        More than one race
    		 15 15
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    MF followed by QMF149
    Reporting group description
    		 Single inhaled dose of mometasone furoate on Day 1 delivered via TH inhaler followed by 4-7 days of washout. On Day 6-9, single inhaled dose of QMF149 delivered via C1 inhaler.

    Primary: Maximum observed Mometasone furoate plasma concentration (Cmax)

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    End point title
    		 Maximum observed Mometasone furoate plasma concentration (Cmax) [1]
    End point description
    Mometasone furoate plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of mometasone furoate was determined with Phoenix WinNonlin (Version 8.0 or higher). A correction factor was applied to MF pharmacokinetic parameters to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (MF) / FPMunprimed (MF)) for MF delivered via TH was 1.26 and for MF delivered via C1 it was 1.62.
    End point type
    Primary
    End point timeframe
    pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6-9
    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: Statistical analysis was not planned
    End point values
    Number of subjects analysed
    Units: pg/mL
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from time zero to the last sampling time point 6h (AUC0-6h) of Mometasone Furoate

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    End point title
    		 Area under the plasma concentration-time curve from time zero to the last sampling time point 6h (AUC0-6h) of Mometasone Furoate [2]
    End point description
    AUC0-6h of mometasone furoate was determined using non-compartment methods with Phoenix WinNonlin (Version 8.0 or higher). The linear trapezoidal rule was used for AUC0-6h calculation. A correction factor was applied to MF pharmacokinetic parameters to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (MF) / FPMunprimed (MF)) for MF delivered via TH was 1.26 and for MF delivered via C1 it was 1.62.
    End point type
    Primary
    End point timeframe
    pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6-9
    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: Statistical analysis was not planned
    End point values
    Number of subjects analysed
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Secondary: Systemic exposure to indacaterol in plasma

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    End point title
    		 Systemic exposure to indacaterol in plasma
    End point description
    Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 6-9 after inhalation of QMF149. A correction factor was applied to indacaterol plasma concentrations to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (indacaterol) / FPMunprimed (indacaterol)) for indacaterol delivered via C1 was 2.0.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.25 and 1 hour post-dose on Day 6-9
    End point values
    		 MF followed by QMF149
    Number of subjects analysed
    24
    Units: pg/mL
    arithmetic mean (standard deviation)
        Pre-dose
    0 ( 0 )
        0.25 hours post-dose
    102.0 ( 54.9 )
        1 hours post-dose
    62.3 ( 26.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 39 days.
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    MF 100 ug via Twisthaler
    Reporting group description
    		 Single inhaled dose of mometasone furoate on Day 1 delivered via TH inhaler followed by 4-7 days of washout

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    QMF149 75/40 ug via Concept 1
    Reporting group description
    		 Single inhaled dose of QMF149 delivered via C1 inhaler on Day 6-9

    Serious adverse events
    		 MF 100 ug via Twisthaler Total QMF149 75/40 ug via Concept 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MF 100 ug via Twisthaler Total QMF149 75/40 ug via Concept 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 24 (12.50%)
    3 / 24 (12.50%)
    0 / 24 (0.00%)
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    1
    0
    Product issues
    Device failure
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    2
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2021
    The protocol was amended to correct the details regarding laboratory assessments, blood sampling and to include the early termination visit assessment details.

    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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