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    Summary
    EudraCT Number:2020-000860-51
    Sponsor's Protocol Code Number:CASK0120
    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:2020-05-04
    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 number2020-000860-51
    A.3Full title of the trial
    The effect of early administered cineole on the course of a common cold
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of early administered cineole on the course of a common cold
    Die Wirkung von frühzeitig verabreichtem Cineol auf den Verlauf einer Erkältung.
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberCASK0120
    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 SponsorCassella-med 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 supportCassella-med GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCassella-med GmbH & Co. KG
    B.5.2Functional name of contact point Global Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressGereonsmühlengasse 1
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50670
    B.5.3.4CountryGermany
    B.5.4Telephone number+492211652718
    B.5.5Fax number+49221165275718
    B.5.6E-mailalexandra.kessler@klosterfrau.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 Soledum® Kapseln forte
    D.2.1.1.2Name of the Marketing Authorisation holderCassella-med 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.3.4Pharmaceutical form Capsule, soft
    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 INNCineole
    D.3.9.1CAS number 470-82-6
    D.3.9.3Other descriptive nameCINEOLE
    D.3.9.4EV Substance CodeSUB20486
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    common cold
    E.1.1.1Medical condition in easily understood language
    common cold
    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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10010106
    E.1.2Term Common cold
    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
    The objective of this clinical trial is to investigate the relation between timing of treatment onset with cineole and course of a common cold with or without acute bronchitis.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Visit 1 – Screening
    1. Age between 18 and 70 years
    2. Recollecting having ≥1 common cold in the last winter season by asking the subject
    3. Informed consent, personally dated and signed by the subject and the investigator, and data protection declaration
    4. Willingness and ability to use an eDiary
    5. Availability of an appropriate device for eDiary data entry, i.e. smartphone, tablet or computer
    6. Subject able to follow the instructions given by the investigator
    Visit 2 – Inclusion diagnosis, start of treatment
    7. Start of eDiary documentation ≤48 hours before first IMP intake
    8. Common cold with or without bronchitis clinically diagnosed by the investigator
    9. “Yes” to the question “Does it feel to you that you are developing a cold or that you have a cold?”
    10. Using Jackson’s criteria, subjects have to report at least a sum score of ≥ 3 in up to the four cold symptoms:
    Nasal discharge
    Nasal obstruction
    Sneezing
    Sore throat
    E.4Principal exclusion criteria
    Visit 1 – Screening
    1. Any known chronic ear, nose, throat and respiratory tract disease or any other known serious disease that can influence the course of the common cold, e.g. chronic bronchitis (WHO Definition), chronic obstructive pulmonary disease (COPD), bronchial asthma, chronic active allergic rhinitis (e.g. dust mite allergy), chronic rhinosinusitis with or without nasal polyp(s), cystic fibrosis within the past 2 years before Visit 1
    2. Pneumonia, pertussis and / or pseudo-croup
    3. Long-term treatment (>14 days) with systemically administered antibiotics within the last 7 days before Visit 1
    4. Previous SARS-CoV-2 infection confirmed by RT-PCR (based on medical history)
    5. Known hypersensitivity to cineole or any of the other compounds of Soledum® forte capsules
    6. Known hereditary fructose intolerance
    7. Presence of clinically relevant renal and / or liver diseases
    8. Any respiratory disease or symptoms related to smoking: asymptomatic smokers are allowed to be included
    9. Presence of immunosuppressive state, malignancy (actual, condition after carcinoma less than 2 years without relapse), autoimmune disease(s), AIDS
    10. Pregnancy (positive urine pregnancy test) or lactation
    11. Female of childbearing potential without medically accepted contraception
    12. History or presence of dependency from alcohol or drugs
    13. Participation in another clinical study, already terminated or still ongoing, within the last 30 days
    14. 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)
    15. Legal incapacity and / or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
    16. Subject in custody by juridical or official order
    17. Subject who has difficulties in understanding the language (German) in which the subject information (informed consent form) is given
    18. Subjects who are members of the staff of the trial center, staff of the sponsor or the clinical research organization (CRO), the investigator himself or close relatives of the investigator

    Visit 2 – Inclusion diagnosis, start of treatment
    Same exclusion criteria as for Visit 1 plus the following ones:
    19. Start of eDiary documentation longer than 12 h after symptom onset
    20. Any known acute ear, nose, throat and respiratory tract disease that can influence the course of the common cold e.g. assured diagnosis of the flu, Covid-19 (acute or previous infection since Visit 1), allergic rhinitis (e.g. allergy to a current available seasonal allergen)
    21. Hypoxemia, i.e. SpO2 ≤92%
    22. Any complications of the common cold that have to be treated with antibiotics
    23. Subjects treated with or need for treatment with antibiotics (systemic), glucocorticosteroids (systemic, per inhalation or nasal), β2-mimetics, theophylline, common cold or cough medication (systemic, per inhalation or nasal) within 7 days prior to Visit 2 or at the time of Visit 2
    24. Regular treatment (i.e. >2 single doses since onset of common cold) with systemic non-steroidal anti-inflammatory drugs [NSAIDs] / analgesics (except low dose acetylsalicylic acid [ASA]) within 7 days prior to Visit 2 or at the time of Visit 2
    25. Drugs without marketing authorization or drugs without marketing authorization in the indication they are used for within 7 days prior to Visit 2 or at the time of Visit 2
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve global symptom severity (AUC-WURSS):
    Derivation of AUC-WURSS is based on mean daily total WURSS-11 scores, which are derived by averaging evening assessment of considered day and morning assessment of the subsequent day per item. The mean item scores will then be summarized to the mean total score of a day. For the AUC-WURSS, the mean daily total WURSS-11 scores will be summed across all days using trapezoidal approximation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily from symptom onset until end of treatment from diary data
    E.5.2Secondary end point(s)
    Wisconsin Upper Respiratory Symptom Survey (WURSS-11):
     Course of mean daily total score:
    Course of mean daily total scores from common cold onset to end of study.
     Course of mean daily group scores (symptom, and QoL domain):
    Course of mean daily group scores from common cold onset to end of study. Mean daily group scores are derived analogously to mean daily total score.
     Course of Single Scores (for each question): mean daily scores will be utilized for WURSS-11 questions 2-10.
    For the first general WURSS-11 question asking for “How sick do you feel today” and last question asking for general assessment of cold compared to the previous day: For these presentations, the worse answer will be chosen for considered day (i.e. maximum score).
     Symptom severity peak:
    The symptom severity peak will be assessed based on mean daily total scores
     Time to remission:
    Remission is considered as present if the first general WURSS-11 question is ≤1 together with a maximum of 1 symptom scored ≤3 and all other symptoms scored 0 of considered day. The day of first documented remission in relation to day of symptom onset is considered as time to remission.
     Time to treatment response:
    Response is defined as a reduction in the total WURSS-11 score by at least 50% of assessed symptom severity peak. The day of first documented treatment response in relation to day of symptom severity peak is considered as time to treatment response.
     Jackson symptom score (JSS) as assessed by investigator:
    o Course of total JSS over Visit 2, Visit 3 and Visit 4:
    The total JSS is derived by summing up eight symptom severity assessments ending up in a score ranging from 0 (no symptoms) to 24 (all symptoms assessed as “Severe”)
    o Course of single symptom severities over Visit 2, Visit 3, Visit 4
     Bronchitis severity scale (BSS)
    o Probability of developing an acute bronchitis as assessed by the percentage of subjects with a total BSS score >2 at least at one study visit (i.e. Visit 2, Visit 3 or Visit 4)
    o Probability of developing an mild, moderate, severe, very severe acute bronchitis according to the classification made by Kardos [17]
    Overall judgement on efficacy by investigator
    Overall judgement on tolerability by investigator / subject
    Days of sick leave and days of bed rest due to common cold since day of onset
    Percentage of subjects with rescue medication intake
    Incidence of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    visit 2, visit 3, visit 4 and daily from symptom onset until end of treatment from diary data
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned25
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state500
    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)
    If symptoms worsen or patient has no response to the test product or withdraws prematurely from the clinical trial, he / she will receive by the investigator - as far as necessary - a standard therapy appropriate for the disease pattern.
    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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-19
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