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    Clinical Trial Results:
    A 24-week randomized, controlled, multicenter, open-label study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD subjects receiving Ultibro® Breezhaler® treatment using the Concept2 inhaler for dose administration and tracking

    Summary
    EudraCT number
    		 2017-001593-42
    Trial protocol
    		 AT   BE   NL  
    Global end of trial date
    24 Jan 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
    CIDD001D2402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03379233
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Forum 1, Novartis Campus, Basel, Switzerland, 4056
    Public contact
    Clinical Trial Information Desk, Novartis Pharma AG,  +41 61 324 1111, clinicaltrial.enquiries@novartis.com
    Scientific contact
    Clinical Trial Information Desk, Novartis Pharma AG,  +41 61 324 1111, clinicaltrial.enquiries@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study considered two primary endpoints: (1) the effect of the intervention on the on-time treatment adherence of the subjects (2) the effect of the intervention on the total treatment adherence of the subjects
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) E6 and Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2018
    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: 4
    Country: Number of subjects enrolled
    Netherlands: 3
    Worldwide total number of subjects
    7
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at Netherlands and Germany between 11 July 2018 (first subject first visit) and 22 January 2019 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 7 subjects were randomized in the study.

    Period 1
    Period 1 title
    Intervention Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Telehealth Group
    Arm description
    		 Subjects inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Concept2 Inhaler with patient application
    Investigational medicinal product code
    Other name
    Ultibro Breezhaler
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Subjects inhaled 110 mcg of indacaterol and 50 mcg of glycopyrronium capsule once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device. The drug products were not under the investigation in this study.

    Arm title
    		 Usual Care Group
    Arm description
    		 Subjects inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Concept 2 inhaler
    Investigational medicinal product code
    Other name
    Ultibro Breezhaler
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Subjects inhaled 110 mcg of indacaterol and 50 mcg of glycopyrronium capsule once daily via Concept2 inhaler. The drug products were not under investigation in this study.

    Number of subjects in period 1
    		Telehealth Group Usual Care Group
    Started
    1
    6
    Completed
    0
    0
    Not completed
    1
    6
         Technical issues with the Concept 2 inhalers
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telehealth Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.

    Reporting group title
    Usual Care Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.

    Reporting group values
    		 Telehealth Group Usual Care Group Total
    Number of subjects
    		 1 6 7
    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 (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1 2 3
        From 65-84 years
    		 0 4 4
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 2 3
        Male
    		 0 4 4
    Race (NIH/OMB)
    Units: Subjects
        White
    		 1 6 7
    Ethnicity (NIH/ OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 1 6 7

    End points

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    End points reporting groups
    Reporting group title
    Telehealth Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.

    Reporting group title
    Usual Care Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.

    Primary: Change in Subject's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline

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    End point title
    		 Change in Subject's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline [1]
    End point description
    On-time treatment adherence was defined as percentage of days on which the subject inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the subject at study start. Due to technical issues, the actual time and day of inhaler use could not be evaluated. Therefore data for this endpoint was not collected and reported.
    End point type
    Primary
    End point timeframe
    Baseline 6 weeks, intervention over 24 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: Due to the early termination of the study, no summary statistics or inferential analyses were performed.
    End point values
    		 Telehealth Group Usual Care Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Number of subjects
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Due to technical issues actual time and day of inhaler use was not evaluated.
    [3] - Due to technical issues actual time and day of inhaler use was not evaluated.
    No statistical analyses for this end point

    Primary: Change in Subject's Total Adherence Over 24 Weeks of Intervention Compared to Baseline

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    End point title
    		 Change in Subject's Total Adherence Over 24 Weeks of Intervention Compared to Baseline [4]
    End point description
    Total adherence was defined as percentage of days on which the subject inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the subject did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler. Due to technical issues, the actual time and day of inhaler use could not be evaluated. Therefore data for this endpoint was not collected and reported.
    End point type
    Primary
    End point timeframe
    Baseline 6 weeks, intervention over 24 weeks
    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: Due to the early termination of the study, no summary statistics or inferential analyses were performed.
    End point values
    		 Telehealth Group Usual Care Group
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Number of subjects
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [5] - Due to technical issues actual time and day of inhaler use was not evaluated.
    [6] - Due to technical issues actual time and day of inhaler use was not evaluated.
    No statistical analyses for this end point

    Secondary: Change from Subject's 6 Weeks Baseline On-time Adherence to the Subject’s On-time Adherence Over the Last Four Weeks of Intervention

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    End point title
    		 Change from Subject's 6 Weeks Baseline On-time Adherence to the Subject’s On-time Adherence Over the Last Four Weeks of Intervention
    End point description
    On-time treatment adherence was defined as percentage of days on which the subject inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed PIT. PIT was defined by the subject at study start. Due to the early discontinuation of the study, only very few subjects were randomized (7) and no subject completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy endpoints. Therefore data for this endpoint was not collected and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 21 - 24
    End point values
    		 Telehealth Group Usual Care Group
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Number of subjects
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [7] - Due to the early discontinuation of the study no subject completed the last 4 weeks of intervention.
    [8] - Due to the early discontinuation of the study no subject completed the last 4 weeks of intervention.
    No statistical analyses for this end point

    Secondary: Change from Subject's 6 Weeks Baseline Total Adherence to the Subject’s Total Adherence Over the Last Four Weeks of Intervention

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    End point title
    		 Change from Subject's 6 Weeks Baseline Total Adherence to the Subject’s Total Adherence Over the Last Four Weeks of Intervention
    End point description
    Total adherence was defined as percentage of days on which the subject inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the subject did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler. Due to the early discontinuation of the study, only very few subjects were randomized (7) and no subject completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy endpoint. Therefore data for this endpoint was not collected and reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 21 - 24
    End point values
    		 Telehealth Group Usual Care Group
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: Number of subjects
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [9] - Due to the early discontinuation of the study no subject completed the last 4 weeks of intervention.
    [10] - Due to the early discontinuation of the study no subject completed the last 4 weeks of intervention.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Telehealth Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks

    Reporting group title
    Usual Care Group
    Reporting group description
    		 Subjects inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.

    Serious adverse events
    		 Telehealth Group Usual Care Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 6 (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
    		 Telehealth Group Usual Care Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 6 (33.33%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2018
    -The classification of this study has been changed to ‘an open label controlled trial’ instead of ‘single blind’ to match with the study procedures already planned for the trial. -The trial phase has been changed from Proof of Concept to Phase III since the Investigational Medicinal Product is a registered/ approved product being investigated in this trial with unapproved Concept2 inhaler and the trial is intended to support registration of the Concept2 inhaler with the DAS with potential inclusion in Summary of Product Characteristics (SmPC). -The study design has been amended to use only a single written informed consent form (ICF) required to be signed by subjects at the start of the clinical trial, instead of two ICFs planned to be used in the earlier study design. The second ICF is therefore no longer required. -Inclusion Criteria 4 has been altered to include subjects who had either (spirometric) post-bronchodilator OR pre-bronchodilator forced expiratory volume in 1 second (FEV1) in the last year, if the COPD diagnosis was confirmed with (spirometric) post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 in the past. The reason to change this inclusion criteria is to also allow subjects with a historical COPD diagnosis (>1 year) to be included in the trial to reflect the routine medical practice in the participating countries. -Exclusion criteria have been updated to reflect the contraception requirements as defined in the Clinical Trial Facilitation Group Recommendations related to contraception and pregnancy testing in clinical trials. -Further changes were made to clarify study procedures, such as editorial changes related to data protection measures and reporting of Serious Adverse Device Event.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Jan 2019
    The study was terminated early due to technical issues with the investigational Concept2 inhalers. Only 7 subjects were randomized in the study and most of these subjects completed only a few weeks in the interventional period.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was prematurely terminated due to technical issues with the investigational Concept2 inhalers. Due to limited and inaccurate data, efficacy endpoints with respect to change in on-time and total treatment adherence were not evaluated.
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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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