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    Clinical Trial Results:
    Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Subjects with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2011-001314-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MP4001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00660517
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meda Pharmaceutical
    Sponsor organisation address
    265 Davidson Avenue, Suite 300, Somerset, United States, NJ 08873-4120
    Public contact
    Group leader study manager, MEDA Pharma GmbH & Co. KG, +49 6172 88801, 42b@medapharma.de
    Scientific contact
    Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co. KG, +49 6172 88801, 42b@medapharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000990-PIP02-10
    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
    27 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this clinical trial was to compare the efficacy and safety of the combination of azelastine hydrochloride nasal spray and fluticasone propionate nasal spray (MP29-02) to placebo and each product alone.
    Protection of trial subjects
    Safety was assessed by incidence, type and severity of adverse events, and by clinical assessments including a focused nasal examination and vital signs measurements. For female subjects of child-bearing potential, a negative urine pregnancy test was required for study participation; the urine pregnancy test was repeated at the end of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2007
    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 States: 610
    Worldwide total number of subjects
    610
    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)
    43
    Adults (18-64 years)
    539
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Male and female subjects 12 years of age and older with a minimum 2-year history of SAR with a positive skin test to Texas Mountain Cedar pollen during the previous year, who met all study inclusion/exclusion criteria were eligible for randomization.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MP29-02
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azelastine hydrochloride and fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Total daily dose:548 mcg azelastine/ 200 mcg fluticasone; 1 spray per nostril twice daily, doses were separated by approximately 12 hours; 2-week study

    Arm title
    		 Azelastine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azelastine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Total daily dose: 548 mcg azelastine; 1 spray per nostril twice daily; 2-week study

    Arm title
    		 Fluticasone
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Total daily dose; 200 mcg fluticasone; 1 spray per nostril twice daily; 2-week study

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Vehicle only (same formulation as MP29-02 used with the exception of the active ingredients); 1 spray per nostril twice daily; 2-week study;

    Number of subjects in period 1
    		MP29-02 Azelastine Fluticasone Placebo
    Started
    153
    153
    153
    151
    Completed
    145
    144
    144
    144
    Not completed
    8
    9
    9
    7
         Consent withdrawn by subject
    1
    1
    2
    2
         Treatment failure
    -
    1
    1
    -
         Adverse event, non-fatal
    1
    3
    1
    1
         Other
    3
    2
    -
    3
         Non-compliance
    3
    2
    3
    1
         Lost to follow-up
    -
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 -

    Reporting group title
    Azelastine
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 MP29-02 Azelastine Fluticasone Placebo Total
    Number of subjects
    		 153 153 153 151 610
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 9 11 10 13 43
        Adults (18-64 years)
    		 136 132 137 131 536
        65 or older
    		 8 9 4 7 28
        Not reported / not in ITT
    		 0 1 2 0 3
    Gender categorical
    Units: Subjects
        Female
    		 97 97 100 102 396
        Male
    		 56 55 51 49 211
        Not reported / not in ITT
    		 0 1 2 0 3

    End points

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    End points reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 -

    Reporting group title
    Azelastine
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Overall change from Baseline in combined (AM + PM) reflective Total Nasal Symptom Score (TNSS) over study period of 14 days.

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    End point title
    		 Overall change from Baseline in combined (AM + PM) reflective Total Nasal Symptom Score (TNSS) over study period of 14 days.
    End point description
    End point type
    Primary
    End point timeframe
    Scores from Day 1 PM to Day 14 AM.
    End point values
    		 MP29-02 Azelastine Fluticasone Placebo
    Number of subjects analysed
    153
    152 [1]
    151 [2]
    150 [3]
    Units: difference in scores
        least squares mean (standard deviation)
    -5.31 ( 5.084 )
    -3.25 ( 4.155 )
    -3.84 ( 4.762 )
    -2.2 ( 4.163 )
    Notes
    [1] - 1 subject not included in the ITT population.
    [2] - 2 subjects not included in the ITT population.
    [3] - 1 subject from the ITT population without available data.
    Statistical analysis title
    		 Comparison MP29-02 vs Placebo
    Comparison groups
    MP29-02 v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Pre-specified with multiplicity adjustement (gatekeeping).
    Statistical analysis title
    		 Comparison MP29-02 vs Azelastine
    Comparison groups
    MP29-02 v Azelastine
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - Pre-specified with multiplicity adjustement (gatekeeping).
    Statistical analysis title
    		 Comparison MP29-02 vs Fluticasone
    Comparison groups
    MP29-02 v Fluticasone
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - Pre-specified with multiplicity adjustement (gatekeeping).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The Treatment Period included three clinic visits: (1) Randomization at Day 1, (2) Day 7 interim visit, and (3) MP4001 MP29-02 Nasal Spray Final Clinical Study Report Meda Pharmaceuticals Day 14 Final Study Visit or Early Termination Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 -

    Reporting group title
    Azelastine
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 MP29-02 Azelastine Fluticasone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 151 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 MP29-02 Azelastine Fluticasone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 153 (18.95%)
    23 / 152 (15.13%)
    22 / 153 (14.38%)
    18 / 151 (11.92%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    11 / 153 (7.19%)
    3 / 152 (1.97%)
    0 / 153 (0.00%)
    0 / 151 (0.00%)
         occurrences all number
    11
    3
    0
    0
    Headache
         subjects affected / exposed
    4 / 153 (2.61%)
    2 / 152 (1.32%)
    6 / 153 (3.92%)
    2 / 151 (1.32%)
         occurrences all number
    4
    2
    6
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    6 / 153 (3.92%)
    4 / 152 (2.63%)
    6 / 153 (3.92%)
    5 / 151 (3.31%)
         occurrences all number
    6
    4
    6
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2007
    prior to clinical start protocol was amended and submitted to the Independent Review Board to implement changes to the methodology, more specific details on procedures, and some administrative modifications.

    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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