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

    Summary
    EudraCT number
    		 2011-001370-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Nov 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
    MP4004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00740792
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meda Pharmaceuticals Inc.
    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, DE 0049 617288801, 42b@medapharma.de
    Scientific contact
    Head Corporate Clinical Affairs, Meda Pharma GmbH & Co. KG, DE 0049 617288801, 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
    04 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy and safety of azelastine hydrochloride and fluticasone propionate combination nasal spray to placebo and to each product alone
    Protection of trial subjects
    No specific additional measures to minimise pain and distress were required. The patients could withdraw from treatment at any time and for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2008
    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: 779
    Worldwide total number of subjects
    779
    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)
    55
    Adults (18-64 years)
    710
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study began with a 7-day single-blind Placebo Lead-in Period during which subjects recorded symptom scores in order to qualify for randomization to the double-blind treatment period. On Visit 2 subjects who satisfied the symptom severity requirements and continued to meet all of the study inclusion/exclusion criteria were randomized.

    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; 14-day double-blind Treatment Period

    Arm title
    		 Azelastine HCL
    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
    1 spray per nostril twice daily; total daily dose: 548 mcg azelastine 14-day double-blind Treatment Period

    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
    1 spray per nostril twice daily; Total daily dose: 200 mcg fluticasone; 14-day double-blind Treatment Period

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasal spray; Same formulation as MP29-02 with the exception of the active ingredients; 1 spray per nostril twice daily; 14-day double-blind Treatment Period

    Number of subjects in period 1
    		MP29-02 Azelastine HCL Fluticasone Placebo
    Started
    195
    194
    189
    201
    Completed
    183
    186
    180
    190
    Not completed
    12
    8
    9
    11
         Consent withdrawn by subject
    1
    1
    -
    -
         Abnormal test procedure results
    -
    1
    -
    -
         Treatment failure
    1
    1
    -
    3
         Adverse event, non-fatal
    3
    1
    1
    3
         Protocol violation
    -
    -
    -
    2
         Other
    5
    2
    3
    3
         Non-compliance
    -
    -
    5
    -
         Lost to follow-up
    2
    1
    -
    -
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

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

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 MP29-02 Azelastine HCL Fluticasone Placebo Total
    Number of subjects
    		 195 194 189 201 779
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 12 12 14 17 55
        Adults (18-64 years)
    		 176 178 172 181 707
        65 or older
    		 5 4 3 2 14
        Not reported / not in ITT
    		 2 0 0 1 3
    Gender categorical
    Units: Subjects
        Female
    		 126 128 121 119 494
        Male
    		 67 66 68 81 282
        Not reported / not in ITT
    		 2 0 0 1 3

    End points

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

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score over the 14-Day Treatment Period: AM and PM Combined

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    End point title
    		 Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score over the 14-Day Treatment Period: AM and PM Combined
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 PM to Day 14 AM.
    End point values
    		 MP29-02 Azelastine HCL Fluticasone Placebo
    Number of subjects analysed
    193 [1]
    193 [2]
    188 [3]
    199 [4]
    Units: difference in scores
        least squares mean (standard deviation)
    -5.54 ( 5.183 )
    -4.54 ( 4.621 )
    -4.55 ( 5.146 )
    -3.03 ( 3.932 )
    Notes
    [1] - Total number of intent-to-treat subjects with available data.
    [2] - Total number of intent-to-treat subjects with available data.
    [3] - Total number of intent-to-treat subjects with available data.
    [4] - Total number of intent-to-treat subjects with available data.
    Statistical analysis title
    		 Comparison MP29-02 vs Placebo
    Comparison groups
    MP29-02 v Placebo
    Number of subjects included in analysis
    392
    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 Azelastine
    Comparison groups
    MP29-02 v Azelastine HCL
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.032 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - 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
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038 [7]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - Pre-specified with multiplicity adjustement (gatekeeping).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At each visit, the study investigators and/or coordinators questioned subjects as to how they had been feeling since their last visit. If the AE was still present at the time the database was locked, a follow-up report was provided at a later date.
    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
    		 548 mcg azelastine/200 mcg fluticasone - 1 spray per nostril twice daily

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 548 mcg - 1 spray per nostril twice daily

    Reporting group title
    Fluticasone
    Reporting group description
    		 200 mcg - 1 spray per nostril twice daily

    Reporting group title
    Placebo
    Reporting group description
    		 Safety population. 0 mcg - 1 spray per nostril twice daily

    Serious adverse events
    		 MP29-02 Azelastine HCL Fluticasone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 200 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    Hepatitis C virus test positive
    Additional description: onset 3 weeks after double-blinded period
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 194 (0.00%)
    0 / 189 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 MP29-02 Azelastine HCL Fluticasone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 195 (15.90%)
    35 / 194 (18.04%)
    24 / 189 (12.70%)
    20 / 200 (10.00%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    4 / 195 (2.05%)
    14 / 194 (7.22%)
    1 / 189 (0.53%)
    1 / 200 (0.50%)
         occurrences all number
    4
    14
    1
    1
    Headache
         subjects affected / exposed
    6 / 195 (3.08%)
    4 / 194 (2.06%)
    5 / 189 (2.65%)
    2 / 200 (1.00%)
         occurrences all number
    6
    4
    5
    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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    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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