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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
    		 2011-001371-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Aug 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
    MP4006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00883168
    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, +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
    04 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2009
    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
    08 Apr 2009
    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: 1801
    Worldwide total number of subjects
    1801
    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)
    199
    Adults (18-64 years)
    1557
    From 65 to 84 years
    45
    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 treatment period during which subjects recorded symptom scores twice daily in order to qualify for randomization to the doubleblind 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 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
    Nasal use
    Dosage and administration details
    Azelastine HCl 548mcg / fluticasone propionate 200mcg; 1 spray per nostril twice daily; 14-day treatment period.

    Arm title
    		 Azelastine nasal spray
    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
    Azelastine HCl 548mcg; 1 spray per nostril twice daily; 14-day treatment period.

    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
    Nasal use
    Dosage and administration details
    Fluticasone propionate 200mcg; 1 spray per nostril twice daily; 14-day treatment period.

    Arm title
    		 Placebo nasal spray
    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, 0 mcg; 1 spray per nostril twice daily; 14-day treatment period.

    Number of subjects in period 1
    		MP29-02 nasal spray Azelastine nasal spray Fluticasone nasal spray Placebo nasal spray
    Started
    451
    449
    450
    451
    Completed
    434
    430
    431
    433
    Not completed
    17
    19
    19
    18
         Consent withdrawn by subject
    2
    1
    2
    1
         Treatment failure
    -
    -
    2
    2
         Adverse event, non-fatal
    3
    4
    3
    5
         Other
    2
    2
    2
    2
         Administrative problems
    1
    -
    -
    -
         Non-compliance
    1
    4
    5
    4
         Lost to follow-up
    2
    1
    1
    -
         Protocol deviation
    6
    7
    4
    4

    Baseline characteristics

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

    Reporting group title
    Azelastine nasal spray
    Reporting group description
    		 -

    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 -

    Reporting group values
    		 MP29-02 nasal spray Azelastine nasal spray Fluticasone nasal spray Placebo nasal spray Total
    Number of subjects
    		 451 449 450 451 1801
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 57 38 56 46 197
        Adults (18-64 years)
    		 382 390 390 387 1549
        65 or older
    		 9 17 4 15 45
        Not reported / not in ITT
    		 3 4 0 3 10
    Gender categorical
    Units: Subjects
        Female
    		 277 271 280 269 1097
        Male
    		 171 174 170 179 694
        Not reported / not in ITT
    		 3 4 0 3 10

    End points

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

    Reporting group title
    Azelastine nasal spray
    Reporting group description
    		 -

    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 -

    Primary: Change from Baseline in 12-Hour Reflective TNSS over the 14-Day Treatment Period: AM and PM Combined

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    End point title
    		 Change from Baseline in 12-Hour Reflective TNSS 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 nasal spray Azelastine nasal spray Fluticasone nasal spray Placebo nasal spray
    Number of subjects analysed
    448 [1]
    443 [2]
    450
    448 [3]
    Units: difference in scores
        least squares mean (standard deviation)
    -5.53 ( 5.18 )
    -4.82 ( 4.762 )
    -4.89 ( 4.655 )
    -3.4 ( 4.342 )
    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.
    Statistical analysis title
    		 Comparison MP29-02 vs Placebo
    Comparison groups
    MP29-02 nasal spray v Placebo nasal spray
    Number of subjects included in analysis
    896
    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 nasal spray v Azelastine nasal spray
    Number of subjects included in analysis
    891
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016 [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 nasal spray v Fluticasone nasal spray
    Number of subjects included in analysis
    898
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.029 [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 consisted of three clinic visits: (1) Randomization at Day 1, (2) Day 7 interim visit, and (3) Day 14 Final Study Visit or Early Termination Visit. Appropriate assessments to evaluate the safety of the study drugs at each study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    MP29-02 nasal spray
    Reporting group description
    		 -

    Reporting group title
    Placebo nasal spray
    Reporting group description
    		 -

    Reporting group title
    Azelastine nasal spray
    Reporting group description
    		 -

    Reporting group title
    Fluticasone nasal spray
    Reporting group description
    		 -

    Serious adverse events
    		 MP29-02 nasal spray Placebo nasal spray Azelastine nasal spray Fluticasone nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 451 (0.22%)
    0 / 449 (0.00%)
    0 / 450 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    lacerated right hand
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 451 (0.00%)
    0 / 449 (0.00%)
    0 / 450 (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
    Infections and infestations
    pyogenic arthritis of the right elbow
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 451 (0.22%)
    0 / 449 (0.00%)
    0 / 450 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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 nasal spray Placebo nasal spray Azelastine nasal spray Fluticasone nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 451 (16.63%)
    55 / 451 (12.20%)
    63 / 449 (14.03%)
    55 / 450 (12.22%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    21 / 451 (4.66%)
    0 / 451 (0.00%)
    23 / 449 (5.12%)
    1 / 450 (0.22%)
         occurrences all number
    21
    0
    23
    1
    Headache
         subjects affected / exposed
    10 / 451 (2.22%)
    4 / 451 (0.89%)
    14 / 449 (3.12%)
    8 / 450 (1.78%)
         occurrences all number
    10
    4
    14
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2009
    for changes see amendment 2
    25 Mar 2009
    To ensure subjects are moderately to severely symptomatic and highly sensitive to a current pollen. Amended protocols included changes to the methodology, increase in study sites and sample size, changes to some inclusion criteria, 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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