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    Clinical Trial Results:
    AN OPEN STUDY TO ASSESS THE ROBUSTNESS OF THE CRC749 DEVICE BY PHARMACEUTICAL PERFORMANCE FOLLOWING TWICE DAILY DOSING OF MGR001 ADMINISTERED VIA ORAL INHALATION IN SUBJECTS WITH ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

    Summary
    EudraCT number
    		 2015-000463-13
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2020
    First version publication date
    28 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MGR001-1010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02474017
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mylan Pharma UK Ltd
    Sponsor organisation address
    20 Station Close, Potters Bar, Hertfordshire, United Kingdom, EN6 1TL
    Public contact
    Richard Allan, Mylan Pharma UK Ltd, +44 1304 626255, richard.allan@mylan.co.uk
    Scientific contact
    Richard Allan, Mylan Pharma UK Ltd, +44 1304 626255, richard.allan@mylan.co.uk
    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
    23 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the robustness of the CRC749 inhaler following 21 (±3) days BID (twice a day) dosing of MGR001 (250/50 μg). - The MGR001 product will be considered robust if inhalers returned in a testable condition meet the proposed commercial specification upon in vitro testing of pharmaceutical performance
    Protection of trial subjects
    Prior to the initiation of the study at each study center, the clinical study protocol, subject information sheet, informed consent form (ICF), and all other relevant study documentation were submitted to and approved by the responsible national Independent Ethics Committee (IEC) / Institutional Review Board (IRB). The study was conducted in accordance with the guidelines set forth in 21 Code of Federal Regulations (CFR), parts 312, 50 and 56.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 2015
    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 Kingdom: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    11
    Adults (18-64 years)
    90
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 One hundred forty-three subjects were screened for the study; one hundred eleven subjects met inclusion criteria, received MGR001 250/50, and were included in Safety Analysis Set.

    Pre-assignment
    Screening details
    		 Subject eligibility were reviewed and documented by an appropriately qualified member of the Investigator’s study team before subjects were included in the study.

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

    Arms
    Arm title
    		 MGR001 250/50
    Arm description
    		 Each subject was given MGR001 250/50, which contained 250 mcg FP and 50 mcg salmeterol [as xinafoate salt] inhalation powder, pre-dispensed for oral inhalation in the CRC749 inhaler. The following treatment was administered during the study: MGR001 250/50 BID for 21.5 (±3) days with the final dose in the clinic at Visit 3 (Day 22 [±3]). Each inhaler contained 60 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MGR001 250/50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use, Oral use
    Dosage and administration details
    one 250/50 inhalation twice a day

    Number of subjects in period 1
    		MGR001 250/50
    Started
    111
    Completed
    108
    Not completed
    3
         Adverse event, non-fatal
    1
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MGR001 250/50
    Reporting group description
    		 Each subject was given MGR001 250/50, which contained 250 mcg FP and 50 mcg salmeterol [as xinafoate salt] inhalation powder, pre-dispensed for oral inhalation in the CRC749 inhaler. The following treatment was administered during the study: MGR001 250/50 BID for 21.5 (±3) days with the final dose in the clinic at Visit 3 (Day 22 [±3]). Each inhaler contained 60 doses.

    Reporting group values
    		 MGR001 250/50 Total
    Number of subjects
    		 111 111
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 11 11
        Adults (18-64 years)
    		 90 90
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.4 ( 16.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 63 63
    Disorder
    Units: Subjects
        Asthma
    		 94 94
        Chronic obstructive pulmonary disease (COPD)
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Subjects with COPD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Number of subjects with COPD in safety analysis set

    Subject analysis set title
    Subjects with Asthma
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Number of subjects with asthma in safety analysis set

    Subject analysis sets values
    		 Subjects with COPD Subjects with Asthma
    Number of subjects
    17
    94
    Age categorical
    Units: Subjects
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    11
        Adults (18-64 years)
    7
    83
        From 65-84 years
    10
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Disorder
    Units: Subjects
        Asthma
        Chronic obstructive pulmonary disease (COPD)

    End points

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    End points reporting groups
    Reporting group title
    MGR001 250/50
    Reporting group description
    		 Each subject was given MGR001 250/50, which contained 250 mcg FP and 50 mcg salmeterol [as xinafoate salt] inhalation powder, pre-dispensed for oral inhalation in the CRC749 inhaler. The following treatment was administered during the study: MGR001 250/50 BID for 21.5 (±3) days with the final dose in the clinic at Visit 3 (Day 22 [±3]). Each inhaler contained 60 doses.

    Subject analysis set title
    Subjects with COPD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Number of subjects with COPD in safety analysis set

    Subject analysis set title
    Subjects with Asthma
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Number of subjects with asthma in safety analysis set

    Primary: In Vitro Testing of FP and salmeterol pharmaceutical performance

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    End point title
    		 In Vitro Testing of FP and salmeterol pharmaceutical performance [1]
    End point description
    All results obtained during analytical testing (i.e., microbiology, water content, emitted dose content uniformity, aerodynamic particle size distribution (APSD), assay, and degradations products) demonstrate that the fluticasone propionate (FP) and salmeterol pharmaceutical performance was preserved. The data were not analysed in a standard way, hence only the conclusions from in vitro testing have been disclosed.
    End point type
    Primary
    End point timeframe
    At Visit 3 Day 22
    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: A statistical analysis of the in vitro data was not required per the protocol, therefore no statistical analysis was performed.
    End point values
    		 MGR001 250/50
    Number of subjects analysed
    111 [2]
    Units: Number
    0
    Notes
    [2] - The data were not analysed in a standard way.
    No statistical analyses for this end point

    Secondary: Disposition of Inhalers Dispensed and Suitability for Testing

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    End point title
    		 Disposition of Inhalers Dispensed and Suitability for Testing
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening to Day 22, Visit 3
    End point values
    		 MGR001 250/50
    Number of subjects analysed
    111
    Units: Number
        Inhalers Issued
    111
        Inhalers Returned
    111
        Inhalers Unsuitable or Unavailable for Testing
    4
        Inhalers Available for Testing
    107
        Inhalers Utilized for Testing
    84
        Spare Inhalers
    23
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent adverse event (TEAE)

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    End point title
    		 Number of subjects with treatment-emergent adverse event (TEAE)
    End point description
    End point type
    Secondary
    End point timeframe
    From screening to Day 22, Visit 3
    End point values
    		 MGR001 250/50
    Number of subjects analysed
    111
    Units: Number
        Number of Subjects With a TEAE
    34
        Number of Subjects With a Serious TEAE
    0
        Number of Subjects With a Treatment-Related TEAE
    15
        Leading to Discontinuation of Study Medication
    1
        Number of Subjects Who Had TEAE Leading to Death
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to Day 22, Visit 3 (End of Study)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18_E
    Reporting groups
    Reporting group title
    MGR001 250/50
    Reporting group description
    		 -

    Serious adverse events
    		 MGR001 250/50
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 111 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MGR001 250/50
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 111 (30.63%)
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 111 (9.91%)
         occurrences all number
    15
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2
    Mouth Ulceration
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    4 / 111 (3.60%)
         occurrences all number
    4
    Oropharyngeal Pain
         subjects affected / exposed
    4 / 111 (3.60%)
         occurrences all number
    5
    Cough
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2
    Dry throat
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Haemoptysis
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Sleep terror
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Infections and infestations
    Ear Infection
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Oral Candidiasis
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 111 (1.80%)
         occurrences all number
    2

    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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    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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