Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A multi-centre, randomised, double blind, placebo controlled study to determine the optimal effective and safe dose of Pollinex Quattro Grass 1.0 mL (Allergy Therapeutics, (UK) Ltd.) for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen

    Summary
    EudraCT number
    		 2017-000333-31
    Trial protocol
    		 DE   AT   PL  
    Global end of trial date
    05 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2019
    First version publication date
    20 Apr 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PQGrass205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergy Therapeutics (UK) Ltd.
    Sponsor organisation address
    Dominion Way, Worthing, United Kingdom, BN14 8SA
    Public contact
    Clinical Research Management, Bencard Allergie GmbH, +49 0893681198, denise.lee@allergytherapeutics.com
    Scientific contact
    Clinical Research Management, Bencard Allergie GmbH, +49 0893681198, denise.lee@allergytherapeutics.com
    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
    05 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the dose-response of Pollinex Quattro Grass 1.0 mL in patients with grass pollen-induced rhinoconjunctivitis.
    Protection of trial subjects
    The conduct of this trial met all local legal and regulatory requirements. The study was conducted in accordance with the principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline E6: Good Clinical Practice (GCP). An informed consent form explaining the procedures of the study including the potential hazards was reviewed and approved by the responsible IEC/IRB before its use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2017
    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
    Poland: 152
    Country: Number of subjects enrolled
    Austria: 19
    Country: Number of subjects enrolled
    Germany: 276
    Worldwide total number of subjects
    447
    EEA total number of subjects
    447
    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)
    447
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted in 43 investigational sites in three countries: Austria, Germany and Poland. Overall, 546 patients were enrolled and screened, 447 patients were randomised and received the study drug. A total of 426 patients were included in the analysis set.

    Pre-assignment
    Screening details
    		 Male or female aged 18 to 50 years with a positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to grass pollen exposure requiring treatment for at least two consecutive seasons prior to study.

    Period 1
    Period 1 title
    Visit 2 - 7 (Visit 1 = Screening)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The identity of study medication administered was not known by the subject, investgators or other persons directly involved in the conduct of the clinical study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trained site personnel administered 6 subcutaneous injections of 1.0 mL each in eligible subjects in the outer third part of the upper arm.

    Arm title
    		 5100 SU
    Arm description
    		 2 subcutaneous injections of Placebo and 4 subcutaneous injections of PQ Grass achieving 5100 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL; Placebo
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, with 2 Placebo injections followed by active formulations at the dose strengths 300, 800, 2000 and 2000 SU/mL given sequentially at weekly intervals.

    Arm title
    		 14400 SU
    Arm description
    		 6 subcutaneous injections of PQ Grass achieving 14400 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 2700, 2700, 2700 and 2700 SU/mL given sequentially at weekly intervals.

    Arm title
    		 27600 SU
    Arm description
    		 6 subcutaneous injections of PQ Grass achieving 27600 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 6000, 6000, 6000 and 6000 SU/mL given sequentially at weekly intervals.

    Arm title
    		 35600 SU
    Arm description
    		 6 subcutaneous injections of PQ Grass achieving 35600 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 8000, 8000, 8000 and 8000 SU/mL given sequentially at weekly intervals.

    Number of subjects in period 1
    		Placebo 5100 SU 14400 SU 27600 SU 35600 SU
    Started
    89
    87
    92
    93
    86
    Completed
    86
    86
    87
    88
    80
    Not completed
    3
    1
    5
    5
    6
         Consent withdrawn by subject
    -
    -
    1
    2
    1
         Adverse event, non-fatal
    1
    1
    4
    2
    5
         no post-treatment TSS available
    1
    -
    -
    -
    -
         Protocol deviation
    1
    -
    -
    1
    -
    Period 2
    Period 2 title
    Follow-up (Visit 8)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The identity of study medication administered was not known by the subject, investgators or other persons directly involved in the conduct of the clinical study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 6 subcutaneous injections of Placebo given sequentially at weekls intervals
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trained site personnel administered 6 subcutaneous injections of 1.0 mL each in eligible subjects in the outer third part of the upper arm.

    Arm title
    		 5100 SU
    Arm description
    		 2 subcutaneous injections of Placebo and 4 subcutaneous injections of PQ Grass achieving 5100 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL; Placebo
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, with 2 Placebo injections followed by active formulations at the dose strengths 300, 800, 2000 and 2000 SU/mL given sequentially at weekly intervals.

    Arm title
    		 14400 SU
    Arm description
    		 6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 2700, 2700, 2700 and 2700 SU/mL given sequentially at weekly intervals.
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 2700, 2700, 2700 and 2700 SU/mL given sequentially at weekly intervals.

    Arm title
    		 27600 SU
    Arm description
    		 6 subcutaneous injections of PQ Grass achieving 27600 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 6000, 6000, 6000 and 6000 SU/mL given sequentially at weekly intervals.

    Arm title
    		 35600 SU
    Arm description
    		 6 subcutaneous injections of PQ Grass achieving 35600 SU cumulative dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trained site personnel administered 6 subcutaneous injections of 1.0 mL each in eligible subjects in the outer third part of the upper arm.

    Investigational medicinal product name
    POLLINEX® Quattro Grass 1.0 mL
    Investigational medicinal product code
    Other name
    PQ Grass
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 8000, 8000, 8000 and 8000 SU/mL given sequentially at weekly intervals.

    Number of subjects in period 2
    		Placebo 5100 SU 14400 SU 27600 SU 35600 SU
    Started
    86
    86
    87
    88
    80
    Completed
    85
    86
    87
    88
    80
    Not completed
    1
    0
    0
    0
    0
         Lost to follow-up
    1
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals

    Reporting group title
    5100 SU
    Reporting group description
    		 2 subcutaneous injections of Placebo and 4 subcutaneous injections of PQ Grass achieving 5100 SU cumulative dose

    Reporting group title
    14400 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 14400 SU cumulative dose

    Reporting group title
    27600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 27600 SU cumulative dose

    Reporting group title
    35600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 35600 SU cumulative dose

    Reporting group values
    		 Placebo 5100 SU 14400 SU 27600 SU 35600 SU Total
    Number of subjects
    		 89 87 92 93 86 447
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 89 87 92 93 0 361
        From 65-84 years
    		 0 0 0 0 86 86
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.6 ( 9.2 ) 29.6 ( 8.4 ) 31.9 ( 9.2 ) 30.3 ( 8.2 ) 30.2 ( 8.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 43 44 36 41 205
        Male
    		 48 44 48 57 45 242
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. Subjects were analysed according to the treatment that they received.

    Subject analysis set title
    mFAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subset of the Full Analysis Set that excluded all patients who did not receive exactly the full cumulative dose to which they were randomized to or who had missing values with respect to the post-treatment TSS.

    Subject analysis sets values
    		 Safety Set mFAS
    Number of subjects
    447
    426
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    447
    426
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.8 ( 8.6 )
    30.7 ( 8.6 )
    Gender categorical
    Units: Subjects
        Female
    205
    192
        Male
    242
    234

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals

    Reporting group title
    5100 SU
    Reporting group description
    		 2 subcutaneous injections of Placebo and 4 subcutaneous injections of PQ Grass achieving 5100 SU cumulative dose

    Reporting group title
    14400 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 14400 SU cumulative dose

    Reporting group title
    27600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 27600 SU cumulative dose

    Reporting group title
    35600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 35600 SU cumulative dose
    Reporting group title
    Placebo
    Reporting group description
    		 6 subcutaneous injections of Placebo given sequentially at weekls intervals

    Reporting group title
    5100 SU
    Reporting group description
    		 2 subcutaneous injections of Placebo and 4 subcutaneous injections of PQ Grass achieving 5100 SU cumulative dose

    Reporting group title
    14400 SU
    Reporting group description
    		 6 subcutaneous injections of 1.0 mL each, at the dose strengths 900, 2700, 2700, 2700, 2700 and 2700 SU/mL given sequentially at weekly intervals.

    Reporting group title
    27600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 27600 SU cumulative dose

    Reporting group title
    35600 SU
    Reporting group description
    		 6 subcutaneous injections of PQ Grass achieving 35600 SU cumulative dose

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. Subjects were analysed according to the treatment that they received.

    Subject analysis set title
    mFAS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subset of the Full Analysis Set that excluded all patients who did not receive exactly the full cumulative dose to which they were randomized to or who had missing values with respect to the post-treatment TSS.

    Primary: Post-treatment TSS following CPT

    		 Close Top of page
    End point title
    		 Post-treatment TSS following CPT
    End point description
    The primary objective of this study was to evaluate the dose-response of PQ Grass in patients with grass pollen-induced rhinoconjunctivitis. The MCP-Mod (multiple comparison procedure - modeling methodology) was used to test for and to characterise a dose-response relationship using the placebo (0 SU) and the 5100, 14400, 27600, and 35600 SU treatment arms as dose levels.
    End point type
    Primary
    End point timeframe
    Approximately four weeks after the last injection.
    End point values
    		 Placebo 5100 SU 14400 SU 27600 SU 35600 SU
    Number of subjects analysed
    85
    86
    87
    88
    80
    Units: Score
        arithmetic mean (standard deviation)
    -1.9 ( 2.2 )
    -3.0 ( 2.9 )
    -3.5 ( 3.0 )
    -3.7 ( 2.9 )
    -3.1 ( 2.8 )
    Attachments
    		 PQGrass205-attachment-primary endpoint-MCP Mod
    Statistical analysis title
    		 MCP-Mod
    Comparison groups
    Placebo v 35600 SU v 5100 SU v 14400 SU v 27600 SU
    Number of subjects included in analysis
    426
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 MCP-Mod
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Within the time period from the first injection of study medication until Visit 8
    Adverse event reporting additional description
    AEs were summarised by treatment group and primary SOC, preferred term, additionally by causality assessment and intensity
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    5100 SU
    Reporting group description
    		 -

    Reporting group title
    14400 SU
    Reporting group description
    		 -

    Reporting group title
    27600 SU
    Reporting group description
    		 -

    Reporting group title
    35600 SU
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 5100 SU 14400 SU 27600 SU 35600 SU
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 87 (0.00%)
    0 / 92 (0.00%)
    0 / 93 (0.00%)
    0 / 86 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 5100 SU 14400 SU 27600 SU 35600 SU
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 89 (59.55%)
    76 / 87 (87.36%)
    78 / 92 (84.78%)
    84 / 93 (90.32%)
    76 / 86 (88.37%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    15 / 89 (16.85%)
    50 / 87 (57.47%)
    55 / 92 (59.78%)
    65 / 93 (69.89%)
    59 / 86 (68.60%)
         occurrences all number
    21
    130
    190
    238
    204
    Injection site swelling
         subjects affected / exposed
    11 / 89 (12.36%)
    52 / 87 (59.77%)
    56 / 92 (60.87%)
    62 / 93 (66.67%)
    59 / 86 (68.60%)
         occurrences all number
    22
    132
    183
    199
    208
    Injection site pruritus
         subjects affected / exposed
    5 / 89 (5.62%)
    40 / 87 (45.98%)
    41 / 92 (44.57%)
    47 / 93 (50.54%)
    40 / 86 (46.51%)
         occurrences all number
    5
    87
    109
    130
    105
    Injections site pain
         subjects affected / exposed
    18 / 89 (20.22%)
    20 / 87 (22.99%)
    23 / 92 (25.00%)
    30 / 93 (32.26%)
    23 / 86 (26.74%)
         occurrences all number
    36
    39
    41
    65
    41
    Injection site urticaria
         subjects affected / exposed
    1 / 89 (1.12%)
    7 / 87 (8.05%)
    8 / 92 (8.70%)
    9 / 93 (9.68%)
    6 / 86 (6.98%)
         occurrences all number
    1
    14
    18
    21
    21
    Injection site warmth
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 87 (3.45%)
    10 / 92 (10.87%)
    8 / 93 (8.60%)
    5 / 86 (5.81%)
         occurrences all number
    1
    4
    15
    14
    1
    Injection site nodule
         subjects affected / exposed
    2 / 89 (2.25%)
    4 / 87 (4.60%)
    6 / 92 (6.52%)
    6 / 93 (6.45%)
    3 / 86 (3.49%)
         occurrences all number
    3
    8
    10
    13
    10
    Headache
         subjects affected / exposed
    5 / 89 (5.62%)
    4 / 87 (4.60%)
    0 / 92 (0.00%)
    3 / 93 (3.23%)
    2 / 86 (2.33%)
         occurrences all number
    6
    5
    0
    3
    2
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    17 / 89 (19.10%)
    12 / 87 (13.79%)
    8 / 92 (8.70%)
    14 / 93 (15.05%)
    10 / 86 (11.63%)
         occurrences all number
    20
    13
    9
    18
    11
    Pharyngitis
         subjects affected / exposed
    6 / 89 (6.74%)
    4 / 87 (4.60%)
    2 / 92 (2.17%)
    3 / 93 (3.23%)
    2 / 86 (2.33%)
         occurrences all number
    6
    4
    2
    3
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2017
    Update to the German Final Study Protocol v 3.0.; PEI requested to incorporate further exclusion requirements.
    18 Sep 2017
    To create a global protocol version - Version 4.0. The protocol update included update of symptpom intensity for exclusion criteria table to reflect the exclusion of all birch and ash allergic patients, addition of withdrawal criterion for patients with past or current asthma who fail spirometry test prior to any IMP administration and replacement of term "rescue medication" with "relief medication".

    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
    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.

    European Medicines Agency © 1995-Fri May 09 18:09:35 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA