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    Clinical Trial Results:
    Non-interventional Study in Allergic Patients Suffering from Grass Pollen Induced Rhinitis/Rhinoconjunctivitis with or without Asthma. Retrospective Assessment of the Efficacy of a Perennial Specific Immunotherapy on the Allergy Symptoms / Disease Activity during the Pollen Season

    Summary
    EudraCT number
    		 2013-004920-12
    Trial protocol
    		 CZ  
    Global end of trial date
    17 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions
    Summary report(s)
    		 PRO-2013_Lay Men Summary
    PRO-2013_Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    PRO-2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LETI Pharma GmbH
    Sponsor organisation address
    Stockumer Str., 28, Witten, Germany, 58453
    Public contact
    Medical Department, LETI Pharma GmbH, 0049 2302202860, info@leti.de
    Scientific contact
    Medical Department, LETI Pharma GmbH, 0049 2302202860, info@leti.de
    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
    02 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    · Patient Reported Outcome (PRO) of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the Symptom and Rescue Medication Score (SMS). · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the VAS for disease activity. · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the allergy symptoms during the grass pollen season 2013 by means of the symptom score (SS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the intake of rescue medication during the grass pollen season 2013 by means of the rescue medication score (RMS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum during the grass pollen season 2013 by means of global assessment.
    Protection of trial subjects
    Prior to participation in this NIS, each patient was informed by the physician on the purpose and extent of the documentation the patient provided by completing the questionnaire. No data provided by the patient in the questionnaire was forwarded to the sponsor without prior written informed consent by the patient. The consent was also necessary for possible verification of the identity of the patient though his patient clinic file (Source Data Verification, EUguideline 95/46/EC and – if applicable - national regulations on data protection). The informed consent procedure and date had to be documented in the patients’ clinic files.
    Background therapy
    		 No background therapy as it was a NIS – questionnaire to collect retrospective data only.
    Evidence for comparator
    		 no comparators
    Actual start date of recruitment
    01 Oct 2013
    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
    Germany: 3
    Country: Number of subjects enrolled
    Czech Republic: 101
    Country: Number of subjects enrolled
    Poland: 80
    Worldwide total number of subjects
    184
    EEA total number of subjects
    184
    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)
    181
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who have been treated during the period October 2012 until April 2013 with one of the 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) were contacted and asked if they were willing to complete a questionnaire about their personal assessment of their grass pollen allergy during the pollen season 2013.

    Pre-assignment
    Screening details
    		 Patients who have been treated during the period October 2012 until April 2013 with one of the 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) were contacted and asked if they were willing to complete a questionnaire about their personalassessment of their grass pollen allergy during the pollen season 2013.

    Period 1
    Period 1 title
    data collection (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not blinded, retrospective questionnaire, Non-interventional

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Depigoid Phleum 100 DDP/mL
    Arm description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 100 DPP/ml.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Depigoid Phleum 100 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    no treatment

    Arm title
    		 Depigoid Phleum 1000 DPP/ml
    Arm description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 1000 DPP/ml.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Depigoid Phleum 1000 DPP/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    no treatment

    Arm title
    		 Depigoid Phleum 5000 DPP/ml
    Arm description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 5000 DPP/ml.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Depigoid Phleum 5000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    no administration

    Arm title
    		 Depigoid Phleum 10000 DPP/mL
    Arm description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 10000 DPP/ml.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Depigoid Phleum 10000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    no treatment

    Number of subjects in period 1
    		Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Started
    47
    48
    49
    40
    Completed
    47
    48
    49
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    data collection
    Reporting group description
    		 -

    Reporting group values
    		 data collection Total
    Number of subjects
    		 184 184
    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)
    		 181 181
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
        Adults
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.02 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 89 89
        Male
    		 95 95

    End points

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    End points reporting groups
    Reporting group title
    Depigoid Phleum 100 DDP/mL
    Reporting group description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 100 DPP/ml.

    Reporting group title
    Depigoid Phleum 1000 DPP/ml
    Reporting group description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 1000 DPP/ml.

    Reporting group title
    Depigoid Phleum 5000 DPP/ml
    Reporting group description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 5000 DPP/ml.

    Reporting group title
    Depigoid Phleum 10000 DPP/mL
    Reporting group description
    		 Patients who have been treated during the period October 2012 until April 2013 with Depigoid Phleum 10000 DPP/ml.

    Primary: #1 Symptom and medication score

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    End point title
    		 #1 Symptom and medication score
    End point description
    The SMS was defined as the sum of the SS and the RMS.
    End point type
    Primary
    End point timeframe
    retrospective data collection OCT-DEC 2013
    End point values
    		 Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Number of subjects analysed
    47
    48
    49
    40
    Units: score
        arithmetic mean (standard deviation)
    11.9 ( 6.71 )
    9.8 ( 6.13 )
    11.1 ( 6.77 )
    10.1 ( 5.96 )
    Statistical analysis title
    		 SMS
    Comparison groups
    Depigoid Phleum 100 DDP/mL v Depigoid Phleum 1000 DPP/ml v Depigoid Phleum 5000 DPP/ml v Depigoid Phleum 10000 DPP/mL
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4211
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: #2 Symptom Score (SS)

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    End point title
    		 #2 Symptom Score (SS)
    End point description
    The SS was the sum score of all symptoms as documented in the Likert scale (none (0) – mild (1) – moderate (2) – severe (3)).
    End point type
    Primary
    End point timeframe
    retrospective data collection OCT-DEC 2013
    End point values
    		 Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Number of subjects analysed
    47
    48
    49
    40
    Units: percentage
        arithmetic mean (standard deviation)
    7.2 ( 3.10 )
    6.3 ( 3.62 )
    7.2 ( 4.13 )
    6.3 ( 3.32 )
    Statistical analysis title
    		 SS
    Comparison groups
    Depigoid Phleum 100 DDP/mL v Depigoid Phleum 1000 DPP/ml v Depigoid Phleum 5000 DPP/ml v Depigoid Phleum 10000 DPP/mL
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3218
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: #3 Rescue Medication Score

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    End point title
    		 #3 Rescue Medication Score
    End point description
    The RMS was defined as the sum score of documented allergy (rescue) medications taken.
    End point type
    Primary
    End point timeframe
    retrospective data collection OCT-DEC 2013
    End point values
    		 Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Number of subjects analysed
    47
    48
    49
    40
    Units: comparison
        arithmetic mean (standard deviation)
    3.2 ( 2.87 )
    2.0 ( 2.22 )
    2.7 ( 2.33 )
    2.9 ( 2.58 )
    Statistical analysis title
    		 RMS
    Statistical analysis description
    Rescue Medication Score
    Comparison groups
    Depigoid Phleum 100 DDP/mL v Depigoid Phleum 1000 DPP/ml v Depigoid Phleum 5000 DPP/ml v Depigoid Phleum 10000 DPP/mL
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.1512
    Method
    		 Kruskal-wallis
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Notes
    [1] - The RMS regarding rhinitis/ rhinoconjunctivitis and lung symptoms was lowest for the 1000 DPP/ml group with a median score of 1.5 and a mean score of 2.0. The difference compared to the 100 DPP/ml group was statistically significant with p = 0.0387. The highest score was found for the 100 DPP/ml group with median 2.0 and mean 3.2. Also for the 10000 DPP/ml group, high values were found (median: 3.0; mean: 2.9).

    Primary: # 4 VAS for disease acitvity

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    End point title
    		 # 4 VAS for disease acitvity
    End point description
    change of disease activity
    End point type
    Primary
    End point timeframe
    retrospective data collection OCT-DEC 2013
    End point values
    		 Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Number of subjects analysed
    47
    48
    49
    40
    Units: cm
        arithmetic mean (standard deviation)
    -3.1 ( 2.18 )
    -4.1 ( 2.59 )
    -3.1 ( 2.25 )
    -4.2 ( 2.05 )
    Statistical analysis title
    		 VAS
    Comparison groups
    Depigoid Phleum 100 DDP/mL v Depigoid Phleum 1000 DPP/ml v Depigoid Phleum 5000 DPP/ml v Depigoid Phleum 10000 DPP/mL
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.0209
    Method
    		 Kruskal-wallis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [2] - comparison

    Primary: #5 global assessment

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    End point title
    		 #5 global assessment
    End point description
    patients rated efficacy of therapy as "positive"
    End point type
    Primary
    End point timeframe
    retrospective data collection OCT-DEC 2013
    End point values
    		 Depigoid Phleum 100 DDP/mL Depigoid Phleum 1000 DPP/ml Depigoid Phleum 5000 DPP/ml Depigoid Phleum 10000 DPP/mL
    Number of subjects analysed
    47
    48
    49
    40
    Units: impression
        number (not applicable)
    25
    30
    28
    28
    Statistical analysis title
    		 global assessment of disease
    Statistical analysis description
    A further endpoint of this NIS was the patients’ global assessment of the efficacy of the pre- seasonal immunotheraypy. Therefore, patients were asked to rate their overall impression as either “excellent”, “good”, (which was classified as “positive” assessment) or as “moderate”, “poor” or “unacceptable” (classified as “negative”).
    Comparison groups
    Depigoid Phleum 100 DDP/mL v Depigoid Phleum 1000 DPP/ml v Depigoid Phleum 5000 DPP/ml v Depigoid Phleum 10000 DPP/mL
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 53.2
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    retrospective questionnaire - no AE reporting (was done within dose finding trial)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    na
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: As this was a NIS - retrospective data collection - no adverse reactions were recorded.

    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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