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    Clinical Trial Results:
    Application of Chronotherapy to Asthma: Towards the Personalisation of Asthma Management. A randomised, mechanistic study of 400mcg Clenil® Modulite® (Beclometasone dipropionate) in the morning versus in the afternoon versus 200mcg twice a day, in Subjects with Atopic Mild to Moderate Asthma

    Summary
    EudraCT number
    		 2019-004309-28
    Trial protocol
    		 GB  
    Global end of trial date
    22 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2024
    First version publication date
    05 Apr 2024
    Other versions
    Summary report(s)
    		 Draft manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    MEU19/383
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MEU: MEU 19/383
    Sponsors
    Sponsor organisation name
    Medicines Evaluation Unit
    Sponsor organisation address
    Southmoor Road, Wythenshawe, United Kingdom, M239QZ
    Public contact
    Nicole Yan , The Medicines Evaluation Unit (MEU) Ltd. (Investigator led study), 0161 9464055, nyan@meu.org.uk
    Scientific contact
    Nicole Yan , The Medicines Evaluation Unit (MEU) Ltd. (Investigator led study), 0161 9464055, nyan@meu.org.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
    Interim
    Date of interim/final analysis
    21 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether in asthma it is more efficacious to take inhaled corticosteroid in the morning, in the afternoon or in divided doses both in the morning and afternoon. Efficacy will be assessed through the measurement of airway narrowing and airway inflammation
    Protection of trial subjects
    Treated in routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2020
    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: 25
    Worldwide total number of subjects
    25
    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)
    0
    Adults (18-64 years)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of 25 participants consented into the study, 22 completed morning dosing, 21 afternoon dosing and 23 twice daily dosing. Overall 21 subjects were compared across all 3 treatment groups for our analysis.

    Pre-assignment
    Screening details
    		 27 subjects were screened and 25 were included in the final study.

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Morning or afternoon or twice daily dosing with BDP 400mcg BDP
    Arm description
    		 Participant was randomised to receive 400mcg BDP either in the morning or in the afternoon or twice a day, followed by a wash out period of 2 weeks and then randomised to the second treatment, washd out and then recieved the third treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Becloethasone BDP
    Investigational medicinal product code
    Other name
    Clenil
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    400mcg taken at 0800-0900 morning dosing

    Arm title
    		 Baseline
    Arm description
    		 Baseline-after washout
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Morning or afternoon or twice daily dosing with BDP 400mcg BDP Baseline
    Started
    25
    25
    Nil
    21
    25
    Completed
    21
    25
    Not completed
    4
    0
         COVID
    3
    -
         family bereavement
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 25 25
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 42 (34 to 52) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Morning or afternoon or twice daily dosing with BDP 400mcg BDP
    Reporting group description
    		 Participant was randomised to receive 400mcg BDP either in the morning or in the afternoon or twice a day, followed by a wash out period of 2 weeks and then randomised to the second treatment, washd out and then recieved the third treatment.

    Reporting group title
    Baseline
    Reporting group description
    		 Baseline-after washout

    Primary: Spirometry

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    End point title
    		 Spirometry
    End point description
    Pre-specified primary end points included the treatment differences for FEV1, PEF and FeNO changes from baseline. The key secondary end points were the treatment differences in the changes in blood eosinophil counts, serum cortisol levels and ACQ-6, reliever medication use and AE. The daily rhythms in lung function parameters, FeNO, blood eosinophil counts and serum cortisol levels were examined.
    End point type
    Primary
    End point timeframe
    Baseline compared to end of each treatment period
    End point values
    		 Morning or afternoon or twice daily dosing with BDP 400mcg BDP Baseline
    Number of subjects analysed
    21
    25
    Units: litres
        number (not applicable)
    21
    25
    Statistical analysis title
    		 FEV1
    Comparison groups
    Morning or afternoon or twice daily dosing with BDP 400mcg BDP v Baseline
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Secondary: Blood Eosinophils

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    End point title
    		 Blood Eosinophils
    End point description
    End point type
    Secondary
    End point timeframe
    Compare each treatment period to baseline
    End point values
    		 Morning or afternoon or twice daily dosing with BDP 400mcg BDP Baseline
    Number of subjects analysed
    21
    25
    Units: cells/ml
        number (not applicable)
    21
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within study end point
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Diamond Pharma
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Afternoon dosing
    Reporting group description
    		 -

    Serious adverse events
    		 Afternoon dosing
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Afternoon dosing
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    Skin and subcutaneous tissue disorders
    Dry mouth
    Additional description: 55 possible AEs were reported, only 1 was thought related to the IMP-dry mouth.
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    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? Yes
    Date
    Interruption
    Restart date
    01 May 2020
    COVID 19
    01 Feb 2021

    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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