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    Clinical Trial Results:
    A multicenter, randomized, double-blind, active-controlled, 2 week treatment, parallel-group study to assess the efficacy and safety of indacaterol acetate delivered via the Concept1 inhalation device in children greater or equal to 6 and less than 12 years of age with asthma

    Summary
    EudraCT number
    		 2016-002113-21
    Trial protocol
    		 DE   SK   BE   HU   HR  
    Global end of trial date
    17 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2020
    First version publication date
    01 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQMF149G2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02892019
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    17 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective for this trial was to evaluate indacaterol acetate 75 μg once daily and 150 μg once daily in terms of change from baseline in pre-dose trough Forced Expiratory Volume in 1 Second after 2 weeks of treatment
    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
    18 Apr 2017
    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
    Germany: 3
    Country: Number of subjects enrolled
    Colombia: 13
    Country: Number of subjects enrolled
    Guatemala: 8
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Philippines: 4
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    South Africa: 20
    Country: Number of subjects enrolled
    Turkey: 13
    Worldwide total number of subjects
    80
    EEA total number of subjects
    13
    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)
    80
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 randomized set : 80 participants (41 and 39) Full analysis set : 79 participants (41 and 38) safety set : 79 participants (41 and 38) per protocol set : 35 participants (35 and 34)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Indacaterol acetate 150 μg o.d.
    Arm description
    		 Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
    Arm type
    		 Experimental

    Investigational medicinal product name
    QMF149
    Investigational medicinal product code
    Other name
    Indacaterol acetate
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Indacaterol acetate 150 μg o.d. delivered via Concept 1 inhaler (in the morning)

    Arm title
    		 Indacaterol acetate 75 μg o.d.
    Arm description
    		 Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
    Arm type
    		 Experimental

    Investigational medicinal product name
    QMF149
    Investigational medicinal product code
    Other name
    Indacaterol acetate
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Indacaterol acetate 75 μg o.d. delivered via Concept 1 inhaler (in the morning)

    Number of subjects in period 1
    		Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Started
    41
    39
    Completed
    40
    36
    Not completed
    1
    3
         randomized but not treated
    -
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Indacaterol acetate 150 μg o.d.
    Reporting group description
    		 Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler

    Reporting group title
    Indacaterol acetate 75 μg o.d.
    Reporting group description
    		 Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler

    Reporting group values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d. Total
    Number of subjects
    		 41 39 80
    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)
    		 41 39 80
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.3 ( 1.47 ) 9.1 ( 1.58 ) -
    Sex: Female, Male
    Units:
        Female
    		 13 15 28
        Male
    		 28 24 52
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 17 17 34
        Black
    		 3 3 6
        Asian
    		 1 3 4
        Native American
    		 3 3 6
        Unknown
    		 1 0 1
        Other
    		 16 13 29

    End points

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    End points reporting groups
    Reporting group title
    Indacaterol acetate 150 μg o.d.
    Reporting group description
    		 Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler

    Reporting group title
    Indacaterol acetate 75 μg o.d.
    Reporting group description
    		 Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler

    Primary: Trough Forced Expiratoty Volume in 1 Second (FEV1)

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    End point title
    		 Trough Forced Expiratoty Volume in 1 Second (FEV1) [1]
    End point description
    Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d. The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
    End point type
    Primary
    End point timeframe
    2 weeks
    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 were performed
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: Liter
        arithmetic mean (standard deviation)
    0.171 ( 0.1664 )
    0.212 ( 0.2521 )
    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 1 and Day 14 after inhalation of indacaterol acetate 75 μg and 150 μg.
    End point type
    Secondary
    End point timeframe
    day 1, day 14
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: pg/mL
    arithmetic mean (standard deviation)
        Day 1 <=-2 hours
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Day 1, 15 minutes
    204.1 ( 98.27 )
    73.7 ( 39.55 )
        Day 1, 1 hour
    125.8 ( 63.13 )
    43.9 ( 20.84 )
        Day 14 <=-2 hours
    80.9 ( 32.51 )
    46.7 ( 29.61 )
        Day 14, 15 minutes
    393.1 ( 182.11 )
    137.3 ( 47.43 )
        Day 14, 1 hour
    255.5 ( 117.67 )
    103.0 ( 37.88 )
    No statistical analyses for this end point

    Secondary: Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire

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    End point title
    		 Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire
    End point description
    Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire (ACQ-IA) score at week 2 (mean change). A decrease in the score shows an improvement. The scale ranges from 0 (no symptoms) to 6 (severe symptoms every day). Results are given as a change as compared from baseline
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.375 ( 0.3796 )
    -0.270 ( 0.6341 )
    No statistical analyses for this end point

    Secondary: Pre-dose morning and evening Peak Expiratoty Flow (PEF)

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    End point title
    		 Pre-dose morning and evening Peak Expiratoty Flow (PEF)
    End point description
    Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: L/min
    arithmetic mean (standard deviation)
        Morning PEF
    29.6 ( 26.41 )
    14.7 ( 29.38 )
        Evening PEF
    29.7 ( 25.57 )
    15.2 ( 28.58 )
    No statistical analyses for this end point

    Secondary: Rescue medication usage (mean daiily number of puffs)

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    End point title
    		 Rescue medication usage (mean daiily number of puffs)
    End point description
    Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.Results given as mean change of puffs of rescue medication.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: number of puffs
        arithmetic mean (standard deviation)
    -0.19 ( 1.479 )
    -0.22 ( 0.930 )
    No statistical analyses for this end point

    Secondary: Rescue medication usage (percentage of rescue medication free days)

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    End point title
    		 Rescue medication usage (percentage of rescue medication free days)
    End point description
    Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: percentage
        arithmetic mean (standard deviation)
    7.4 ( 22.37 )
    3.1 ( 19.42 )
    No statistical analyses for this end point

    Secondary: Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)

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    End point title
    		 Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
    End point description
    FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: Liter
    arithmetic mean (standard deviation)
        30 minutes
    0.234 ( 0.1786 )
    0.224 ( 0.2459 )
        1 hour
    0.224 ( 0.1725 )
    0.258 ( 0.2451 )
    No statistical analyses for this end point

    Secondary: Symptoms as recorded by patient e-diary (mean total daily symptom score)

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    End point title
    		 Symptoms as recorded by patient e-diary (mean total daily symptom score)
    End point description
    Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change) The scale rages from 0 (no problem) - 4 (very severe problems).
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.18 ( 0.695 )
    0.08 ( 0.365 )
    No statistical analyses for this end point

    Secondary: Symptoms as recorded by patient e-diary (percentage of asthma symptoms free days)

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    End point title
    		 Symptoms as recorded by patient e-diary (percentage of asthma symptoms free days)
    End point description
    Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Indacaterol acetate 150 μg o.d. Indacaterol acetate 75 μg o.d.
    Number of subjects analysed
    41
    38
    Units: percentage
        arithmetic mean (standard deviation)
    12.3 ( 21.25 )
    4.4 ( 26.60 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    QAB149 150 ug OD
    Reporting group description
    		 QAB149 150 ug OD

    Reporting group title
    QAB149 75 ug OD
    Reporting group description
    		 QAB149 75 ug OD

    Serious adverse events
    		 QAB149 150 ug OD QAB149 75 ug OD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 38 (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: 2%
    Non-serious adverse events
    		 QAB149 150 ug OD QAB149 75 ug OD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 41 (7.32%)
    13 / 38 (34.21%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Peak expiratory flow rate decreased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Cardiac disorders
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Dysphonia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Rhinitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    3

    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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    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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