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    Summary
    EudraCT Number:2019-001717-17
    Sponsor's Protocol Code Number:P1901GF
    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:2019-07-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-001717-17
    A.3Full title of the trial
    A multi-centre, randomised, placebo-controlled, double-blind parallel-group trial to assess the efficacy and safety of SIA capsules in subjects with acute rhinosinusitis.
    Wirksamkeit und Verträglichkeit von SIA-Kapseln bei akuter Rhinosinusitis
    - Eine multizentrische, randomisierte, placebo-kontrollierte, doppelblinde klinische Prüfung mit zwei parallelen Behandlungsgruppen -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-centre, randomised, placebo-controlled, double-blind parallel-group trial to assess the efficacy and safety of SIA capsules in subjects with acute rhinosinusitis.
    Wirksamkeit und Verträglichkeit von SIA-Kapseln bei akuter Nasennebenhöhlenentzündung
    - Eine multizentrische, randomisierte, placebo-kontrollierte, doppelblinde klinische Prüfung mit zwei parallelen Behandlungsgruppen -
    A.4.1Sponsor's protocol code numberP1901GF
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPohl-Boskamp GmbH & Co. KG
    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 supportPohl-Boskamp GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPohl-Boskamp GmbH & Co. KG
    B.5.2Functional name of contact pointDirector Medicine & Clin. Research
    B.5.3 Address:
    B.5.3.1Street AddressKieler Strasse 11
    B.5.3.2Town/ cityHohenlockstedt
    B.5.3.3Post code25551
    B.5.3.4CountryGermany
    B.5.4Telephone number+49482659240
    B.5.5Fax number+49482659213
    B.5.6E-mailt.wittig@pohl-boskamp.de
    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 GeloMyrtol forte
    D.2.1.1.2Name of the Marketing Authorisation holderG. Pohl-Boskamp GmbH & Co. KG
    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 nameSIA 300 mg capsule
    D.3.2Product code R05CP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDISTILLATE OF A MIXTURE OF RECTIFIED EUCALYPTUS OIL, RECTIFIED SWEET ORANGE OIL, RECTIFIED MYRTLE OIL AND RECTIFIED LEMON OIL IN A RATIO OF 66:32:1:1
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameDISTILLATE OF A MIXTURE OF RECTIFIED EUCALYPTUS OIL, RECTIFIED SWEET ORANGE OIL, RECTIFIED MYRTLE OIL AND RECTIFIED LEMON OIL IN A RATIO OF 66:32:1:1
    D.3.9.4EV Substance CodeSUB116177
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    acute rhinosinusitis
    akute Nasennebenhöhlenentzündung
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040754
    E.1.2Term Sinusitis acute NOS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of orally administered essentials oils (SIA capsules) compared with placebo for 2 weeks in adults with acute rhinosinusitis.
    E.2.2Secondary objectives of the trial
    To assess the safety of 2 weeks of oral treatment with essentials oils (SIA capsules) compared with placebo in adults with acute rhinosinusitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Voluntary written informed consent for trial participation and handling of personal data in concurrence with the European General Data Protection Declaration (GDPR) has been obtained prior to performance of any trial specific procedures or assessments
    2. Male or female outpatient adults aged ≥18 years
    3. Clinically evident diagnosis of acute rhinosinusitis
    4. Severity of the five main rhinosinusitis symptoms (MSS) characterised as follows based on the investigator’s ratings at Visit 1 (screening):
    - Sum score MSSINV ≥8 points and ≤12 points
    - Individual score for facial pain/ pressure ≥1 (mild) and ≤2 (moderate)
    5. Presence of rhinosinusitis symptoms for 3 days or less (i.e. symptoms started ≤3 days before Visit 1)
    E.4Principal exclusion criteria
    1. Acute symptoms of a known allergic rhinitis
    2. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever >38.5°C), orbital complications, severe unilateral frontal headache or toothache)
    3. History of chronic rhinosinusitis with exacerbations within 6 months prior to Visit 1
    4. History of polyposis nasi
    5. History of odontogenic sinusitis
    6. History of chronic nasal congestion (e.g. due to known anatomical deviations of the nasal septum etc.)
    7. Paranasal sinus surgery up to two years prior to Visit 1
    8. History of cystic fibrosis
    9. History of asthma with exacerbations (asthma attacks) within the past 30 days prior to Visit 1
    10. Known hypersensitivity to trial medication or excipients
    11. Underlying diseases leading to significant immune deficiency
    12. Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct at the time of inclusion or within the last 6 months before Visit 1.
    13. History of severe somatopathic, neurological and/ or psychiatric diseases
    14. Malignant growth (actual, condition after carcinoma less than 5 years without relapse)
    15. Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without highly effective contraception (failure rate less than 1%)
    16. Treatment with systemic antibiotics, or with nasal or systemic corticosteroids within the last 4 weeks prior to Visit 1 (excluding inhaled corticosteroids for mild to moderate persistent asthma)
    17. Treatment with mucolytics/ secretolytics, antihistamines, or alternative medicine preparations or drugs with immunomodulating properties within the last 7 days prior to Visit 1
    18. Use of paracetamol, decongestant preparations, systemic analgesics (including systemic non-steroidal anti-inflammatory drugs [NSAIDs]), the day of Visit 1 (before randomisation)
    19. History or presence of drug or alcohol abuse
    20. Parallel participation in another clinical trial with an investigational product, participation in a clinical trial within less than 6 weeks prior to Visit 1
    21. Known to be, or suspected of being unable to comply with the trial protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    22. Legal incapacity and/ or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
    23. Subject in custody by juridical or official order
    24. Subject who has difficulties in understanding the language (German) in which the subject information (informed consent form) is given
    25. Subjects who are members of the staff of the trial centre, staff of the sponsor or the clinical research organisation (CRO), the investigator him-/ herself or close relatives of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    1. Difference in mean MSS(INV) scores at Visit 4 (SIA vs. placebo)
    2. Difference in mean MSS(INV) scores at Visit 3 (SIA vs. placebo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 and Visit 4
    E.5.2Secondary end point(s)
    1. Difference in mean MSSPAT scores in the evening before Visit 3 (SIA vs. placebo)
    2. Difference in mean MSSPAT scores in the evening before Visit 4 (SIA vs. placebo)
    3. Difference in mean MSSINV scores at Visit 2 (SIA vs. placebo)
    4. Difference in mean MSSPAT scores in the evening before Visit 2 (SIA vs. placebo)

    The secondary efficacy endpoint “Differences in responder rates at Visits 2, 3 and 4 (SIA vs. placebo)” will be analysed using the generalized linear mixed model with binary outcome using Baseline (Visit 1) as covariate, patient as random effect repeated in visit. The respective visit (Visit 2, Visit 3 or Visit 4) will be selected from the model by using respective contrasts. .
    A responder is defined by the investigator’s and subject’s assessments according to the definition in chapter 9.11. The order of testing will be as follows:
    5. Difference in responder rates at Visit 4 (SIA vs. placebo) by investigator
    6. Difference in responder rates at Visit 4 (SIA vs. placebo) by patient
    7. Difference in responder rates at Visit 3 (SIA vs. placebo) by investigator
    8. Difference in responder rates at Visit 3 (SIA vs. placebo) by Patient
    9. Difference in responder rates at Visit 2 (SIA vs. placebo) by investigator
    10. Difference in responder rates at Visit 2 (SIA vs. placebo) by patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2, Visit 3, Visit 4 and diary data over 15 days treatment period
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned34
    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 No
    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
    It is defined in the protocol, that database lock is defined as end of clinical trial
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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.1.2.1Number of subjects for this age range: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 No
    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 state456
    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)
    acute rhinosinusitis is a self-limiting disease. Patients will receive normal standard of care if needed after the end of clinical trial
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-30
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