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    Summary
    EudraCT Number:2009-018112-26
    Sponsor's Protocol Code Number:DR-CR-GEN01S02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-02-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-018112-26
    A.3Full title of the trial
    Efficacy and tolerability of Citrus/Cydonia comp.® 1% solution for injection in patients with grass pollen seasonal allergic rhinitis: A randomised, double-blind, placebo-controlled clinical trial
    A.3.2Name or abbreviated title of the trial where available
    The CiSAR Study
    A.4.1Sponsor's protocol code numberDR-CR-GEN01S02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWeleda AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gencydo 1%
    D.2.1.1.2Name of the Marketing Authorisation holderWeleda AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCitrus/ Cydonia comp.
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN0
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor code0
    D.3.9.3Other descriptive nameCitrus Limon, succus
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 to 12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN0
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor code0
    D.3.9.3Other descriptive nameCydonia oblonga
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Grass pollen allergic rhinitis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Clinically relevant reduction of symptom severity of grass pollen rhinitis
    E.2.2Secondary objectives of the trial
    2. To examine the safety of treatment
    3. To examine treatment effects on immunological parameters
    4. To develop and validate an immunological model
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients:
    •Written informed consent
    •Age ≥ 18 and < 60 years.
    •Seasonal allergic rhinitis:
    -Duration of respective complaints at least 2 years
    -RAST for grass pollen: ≥ 2
    -Positive skin prick test on grass pollen
    -Suffering from the following symptoms:
    sneezing, itching nose, nasal obstruction and watery nasal discharge
    -Severity score of at least two of the four symptoms ≥ 2; ranging from 0 = not present to 3 = severe.
    -The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
    - Average Total Symptom Score in the wash-out period ≥ 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20



    Healthy volunteers:
    •Written informed consent
    •Age ≥ 18 and < 60 years
    •RAST for seasonal AR related grass and birch pollen = 0
    •No history of seasonal AR symptoms for at least 2 years
    E.4Principal exclusion criteria
    Patients:
    •Chronic autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
    •Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.®
    •Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study
    •Previous use of medicinal products containing Citrus and/or Cydonia
    •Pregnancy or lactation
    •Severe internal or systemic disease (e.g. cardiac, hepatic, renal diseases)
    •A known history of drug, alcohol and/or medication dependence or addiction
    •Immunotherapy in the last two years
    •Other allergies (no seasonal AR)

    Healthy volunteers:

    •Nasal seasonal AR related symptoms during the pollen season: sneezing, itching nose, nasal obstruction and watery nasal discharge
    •Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
    •Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study.
    •Pregnancy or lactation
    •Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
    •A known history of drug, alcohol and/or medication dependence or addiction
    •Immunotherapy in the last two years
    •Other allergies (no seasonal AR)
    E.5 End points
    E.5.1Primary end point(s)
    “Days with symptom control” defined by:
    a)A Total Symptom Score of ≤ 8 (while exposed to a mean pollen count of 20-50) or ≤ 12 (while exposed to a mean pollen count of > 50)
    and
    b)No use of rescue medication
    in the treatment group compared to the placebo group in the last two weeks of treatment

    The use of rescue medication has an impact on symptom severity. Therefore, the primary endpoint is a combined parameter reflecting both symptom severity and the intake of rescue medication. The “number of days with symptom control” is defined as the number of days without intake of rescue medication and a symptom score below a pre-defined and clinically justified threshold (European Medicines Agency, 2009). Definition of this threshold is related to the actual pollen count: With a pollen count > 50, a total symptom score (TSS) of ≤ 12 without rescue medication is considered a clinically relevant reduction. With a pollen count ranging from 20 to 50, a TSS of ≤ 8 without rescue medication is considered a clinically relevant reduction of symptoms.
    Superiority of treatment with Citrus/Cydonia comp. is accepted if the mean number of days with symptom control in the two treatment groups results in a difference of at least 30% in favour of Citrus/Cydonia comp in the last two weeks of treatment.

    Severity of symptoms for the day will be recorded every evening in an online questionnaire by the patient. This questionnaire measures the severity of nasal symptoms (nasal obstruction, itching nose, sneezing and watery nasal discharge) and non-nasal symptoms (itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat). The total Nasal Score (TNS) and the total Non Nasal Score (TNNS) can vary from 0-12. The total symptom scores (TSS) are calculated by adding TNS and TNNS scores. For details see chapter 8, examination procedures.
    Intake of SAR-related rescue medication (Loradatine) will also be recorded daily by the patient in the online questionnaire.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 120
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-04
    P. End of Trial
    P.End of Trial StatusOngoing
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