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    Clinical Trial Results:
    Active-Controlled Trial of the Safety and Tolerability of MP29-02 in Subjects with Chronic Allergic or Nonallergic Rhinitis

    Summary
    EudraCT number
    		 2011-001368-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Jun 2009

    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
    MP4000
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meda Pharmaceuticals
    Sponsor organisation address
    265 Davidson Avenue, Suite 300, Somerset, United States, 08873-4120
    Public contact
    Group leader study managers, MEDA Pharma GmbH Co. KG, +49 617288801, 42b@medapharma.de
    Scientific contact
    Head Corporate Clinical Affairs, MEDA Pharma GmbH Co. KG, +49 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
    05 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jun 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of azelastine hydrochloride and fluticasone propionate combination nasal spray in chronic use daily over a 1-year period.
    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
    16 Jan 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
    India: 612
    Worldwide total number of subjects
    612
    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)
    1
    Adolescents (12-17 years)
    36
    Adults (18-64 years)
    569
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects 12 to 80 years of age with a history of chronic rhinitis symptoms due to perennial allergic rhinitis, perennial nonallergic rhinitis, or VMR who might benefit from continuous therapy with MP29-02 were considered for entry into the study. Subjects who met the study entry criteria were enrolled following an initial 7-day screening period.

    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
    Yes

    Arm title
    		 MP29-02 nasal spray
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azelastine hydrochloride and fluticasone propionate
    Investigational medicinal product code
    MP29-02
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use , Topical use
    Dosage and administration details
    Mode of Administration: Topical/intranasal spray Dose: 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate/ spray Regimen: 1 spray per nostril bid (morning [AM] and evening [PM]) Duration of Treatment: 12 months

    Arm title
    		 Fluticasone nasal spray
    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
    Intranasal use , Topical use
    Dosage and administration details
    Mode of Administration: Topical/intranasal spray Dose: 50 mcg fluticasone propionate/ spray Regimen: 2 sprays per nostril qd (AM) Duration of Treatment: 12 months

    Number of subjects in period 1
    		MP29-02 nasal spray Fluticasone nasal spray
    Started
    405
    207
    Completed
    312
    152
    Not completed
    93
    55
         Consent withdrawn by subject
    12
    8
         Abnormal test procedure results
    2
    -
         Treatment failure
    -
    2
         Adverse event, non-fatal
    11
    6
         Other
    2
    3
         Administrative problems
    15
    6
         Non-compliance
    5
    3
         Did not have an end of study CRF page
    5
    4
         Lost to follow-up
    38
    20
         Protocol deviation
    3
    3

    Baseline characteristics

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

    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Reporting group values
    		 MP29-02 nasal spray Fluticasone nasal spray Total
    Number of subjects
    		 405 207 612
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 28 8 36
        Adults (18-64 years)
    		 373 196 569
        65 years and over
    		 3 3 6
        Not recorded
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 164 97 261
        Male
    		 240 110 350
        Not recorded
    		 1 0 1

    End points

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

    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Subject analysis set title
    Safety population for MP29-02
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population for MP29-02.

    Subject analysis set title
    Safety population for Fluticasone Propionate
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population for Fluticasone Propionate.

    Primary: Number of AEs Reported

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    End point title
    		 Number of AEs Reported [1]
    End point description
    End point type
    Primary
    End point timeframe
    Safety and tolerability assessments were made at Months 1, 3, 6, 9, and 12. Phone contact was made at Months 2, 4, 5, 7, 8, 10, and 11 during the 12-month evaluation period.
    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 for the safety end point - number of AEs reported - was performed.
    End point values
    		 Safety population for MP29-02 Safety population for Fluticasone Propionate
    Number of subjects analysed
    404
    207
    Units: number of subjects
        All Treatment-Emergent AEs
    653
    313
        All Treatment-Related AEs
    61
    46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety and tolerability assessments were made at Months 1, 3, 6, 9, and 12. Phone contact was made at Months 2, 4, 5, 7, 8, 10, and 11 during the 12-month evaluation period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Reporting group title
    MP29-02 nasal spray
    Reporting group description
    		 -

    Serious adverse events
    		 Fluticasone nasal spray MP29-02 nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 207 (0.48%)
    3 / 404 (0.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 404 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 404 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 404 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 404 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 404 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.7%
    Non-serious adverse events
    		 Fluticasone nasal spray MP29-02 nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 207 (44.44%)
    188 / 404 (46.53%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 207 (13.53%)
    50 / 404 (12.38%)
         occurrences all number
    28
    50
    Dysgeusia
         subjects affected / exposed
    1 / 207 (0.48%)
    11 / 404 (2.72%)
         occurrences all number
    1
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    22 / 207 (10.63%)
    33 / 404 (8.17%)
         occurrences all number
    22
    33
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 207 (2.42%)
    20 / 404 (4.95%)
         occurrences all number
    5
    20
    Nasal congestion
         subjects affected / exposed
    8 / 207 (3.86%)
    12 / 404 (2.97%)
         occurrences all number
    8
    12
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    5 / 207 (2.42%)
    11 / 404 (2.72%)
         occurrences all number
    5
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2007
    Protocol amended to include change in methodology of the study (increase of patients in one treatment arm of the sub-study)
    21 Jan 2008
    Protocol amended to include administrative modifications related to the implementation of the first protocol amendment

    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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