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    Clinical Trial Results:
    Open label two treatment half-side comparative study to analyse difference in nasal bioavailability between MP29-02 and fluticasone propionate.

    Summary
    EudraCT number
    		 2015-002865-40
    Trial protocol
    		 BE  
    Global end of trial date
    25 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2021
    First version publication date
    25 Jul 2021
    Other versions
    Summary report(s)
    		 Cancelled Before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    BIODYMF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    25 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 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
    Belgium: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants.

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Male and female patients - Age: 18 – 70 years (included) - Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study - Willing and able to provide informed consent

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Flixonase aqua
    Arm description
    		 1 dose each in a different nostril administered via single dose nasal spray.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate (flixonase aqua)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Each spray delivers 50 mcg of fluticasone propionate.

    Arm title
    		 MP29-02
    Arm description
    		 1 dose each in a different nostril administered via single dose nasal spray.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MP29-02
    Investigational medicinal product code
    Other name
    Dymista
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Local use , Nasal use
    Dosage and administration details
    Total dose: 0,14 g gram(s). Nasal use.

    Number of subjects in period 1
    		Flixonase aqua MP29-02
    Started
    99999
    99999
    Completed
    99999
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flixonase aqua
    Reporting group description
    		 1 dose each in a different nostril administered via single dose nasal spray.

    Reporting group title
    MP29-02
    Reporting group description
    		 1 dose each in a different nostril administered via single dose nasal spray.

    Reporting group values
    		 Flixonase aqua MP29-02 Total
    Number of subjects
    		 99999 99999 99999
    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)
    		 99999 99999 99999
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999 99999
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Flixonase aqua
    Reporting group description
    		 1 dose each in a different nostril administered via single dose nasal spray.

    Reporting group title
    MP29-02
    Reporting group description
    		 1 dose each in a different nostril administered via single dose nasal spray.

    Primary: To determine the bioavailability of MP29-02 in comparison with commercially available fluticasone propionate in human nasal mucosa.

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    End point title
    		 To determine the bioavailability of MP29-02 in comparison with commercially available fluticasone propionate in human nasal mucosa. [1]
    End point description
    99999 is "not applicable" value or 0 participants.
    End point type
    Primary
    End point timeframe
    Approximately 1 hour after administration (during surgery).
    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 available.
    End point values
    		 Flixonase aqua MP29-02
    Number of subjects analysed
    99999 [2]
    99999 [3]
    Units: fraction
        number (not applicable)
    99999
    99999
    Notes
    [2] - No patients enrolled in the trial.
    [3] - No patients enrolled in the trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were recorded for the participating patients.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Nov 2016
    Amendment to information in the CT application form, amendment to the protocol, changes in conduct or management of the trial, : Some issues were clarified in the protocol, as well as the description of the IMP, previously indicated as flixonase aqua, was changed to a more broad description (without using 1 specific brand) as the use of the active substance fluticasone propionate.

    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.
    No patients have been enrolled. The trial was never initiated.
    For support, Contact us.
    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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