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    Summary
    EudraCT Number:2008-002794-13
    Sponsor's Protocol Code Number:ARhiSi-1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-17
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-002794-13
    A.3Full title of the trial
    A multi-centre, double-blind, placebo-controlled, randomised, parallel group study to assess the efficacy and safety of two different dosages of a herbal medicinal product (dry extract BNO-1016) in patients with acutre rhinosinusitis
    Multi-centre, double-blind, placebo-controlled, randomised, parallel group study
    A.4.1Sponsor's protocol code numberARhiSi-1
    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 SponsorBionorica AG
    B.1.3.4CountryGermany
    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 No
    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 nameBNO-1016
    D.3.2Product code BNO-1016
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBNO-1016
    D.3.9.3Other descriptive nameDry extract of a fixed combination of the following 5 herbal drugs (ratio 1:3:3:3:3), DER (3-5:1)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80 mg to per coated tablet
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameGENTIAN ROOT
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000040688
    D.3.9.3Other descriptive namePRIMULA FLOWERS
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000043472
    D.3.9.3Other descriptive nameRUMICIS ASETOSA
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000043483
    D.3.9.3Other descriptive nameVERBENA HERB
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameELDER FLOWER
    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 Yes
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute rhinosinusitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052106
    E.1.2Term Rhinosinusitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a 15 days treatment with a herbal medicinal product (BNO-1016) for treatment of acute rhinosinusitis in adult patients in two different dosages compared to placebo on the basis of the major symptom score (MSS) assessed by the investigator.
    E.2.2Secondary objectives of the trial
    To assess the safety of two different dosages of BNO-1016 compared to placebo applied in patients with acute rhinosinusitis.
    To determine the dose with the best benefit / risk ratio for the treatment of acute rhinosinusitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent including data protection declaration

    2. Male and female outpatients aged ≥18 and ≤ 75 years

    3. Diagnosis of acute rhinosinusitis - characterized by a major symptom score* (MSS) ≥8 points (minimum 0, maximum 15 points) - confirmed by ultrasonography of paranasal sinuses - with presence of symptoms ≤ 3 days prior to inclusion

    *Out of the 5 main rhinosinusitis symptoms at least 3 must be present. Among these the presence of nasal congestion and facial pain / pressure is mandatory.
    E.4Principal exclusion criteria
    1. Chronic rhinosinusitis

    2. Polyposis nasi

    3. Cystic fibrosis

    4. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow

    5. Acute symptoms of allergic rhinitis

    6. Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion

    7. Known hypersensitivity to study medication or excipients

    8. Underlying diseases leading to significant immune deficiency

    9. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C, orbital complications, severe unilateral frontal headache or toothache)

    10. Odontogenic sinusitis

    11. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids (excluding inhaled corticosteroids for mild to moderate persistent asthma) within the last 4 weeks prior to study inclusion

    12. Treatment with decongestant preparations, analgesics (except Paracetamol), mucolytics / secretolytics, antihistamines, or alternative medicine preparations for treatment of common coldlike symptoms or with immunomodulating properties within the last 7 days prior to study inclusion

    13. Patients requiring antibiotic treatment for any condition at study entry

    14. Pregnancy or lactation

    15. Severe diseases of liver or kidney

    16. Severe somatopathic, neurological and / or psychiatric diseases

    17. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse)

    18.History of alcohol or drug abuse

    19. Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study

    20. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history

    21. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study

    22. Patients in custody by juridical or official order

    23. Evidence of an uncooperative attitude

    24. Patients who have difficulties in understanding the language (German) in which the patient information is given
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the MSS over the 15-day treatment period which will be calculated as “area under the curve” by the trapezoid rule. The MSS is the sum of the investigator’s morning assessment of the 5 main rhinosinusitis symptoms on Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7), Visit 4 (Day 10) and Visit 5 (Day 14) based on the 4-point rating scale given below:
    0 = None / Not present
    1 = Mild
    2 = Moderate
    3 = Severe
    The 5 main rhinosinusitis symptoms are:
    - rhinorrhea (anterior discharge)
    - postnasal drip
    - nasal congestion
    - headache
    - facial pain / pressure
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    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 Yes
    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
    End of trial will be end of April 2009 at last patient out of alltogether 450 patients.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-12-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state450
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Please see protocol chapter 4.10.
    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 Decision2009-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-29
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