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    Summary
    EudraCT Number:2020-000429-17
    Sponsor's Protocol Code Number:00
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-14
    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 ConcernedNorway - NOMA
    A.2EudraCT number2020-000429-17
    A.3Full title of the trial
    BASIC - Better treatment for acute sinusitis in primary care: a randomized controlled trial testing topical treatment with chloramphenicol eye drops
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Better treatment for acute sinusitis in primary care
    A.3.2Name or abbreviated title of the trial where available
    BASIC
    A.4.1Sponsor's protocol code number00
    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 SponsorUniversity of Oslo, Faculty of Medicine, Institute of Health and Society
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNorwegian Research Council
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oslo, Faculty of Medicine, Institute of Health and Society
    B.5.2Functional name of contact pointDepartment of General Practice
    B.5.3 Address:
    B.5.3.1Street AddressKirkeveien 166
    B.5.3.2Town/ cityOslo
    B.5.3.4CountryNorway
    B.5.6E-mailbasic-studien@helsam.uio.no
    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 Kloramfenikol Santen 5mg/ml eye drops, solution
    D.2.1.1.2Name of the Marketing Authorisation holderSanten Oy
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular 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
    Sinusitis
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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. Does use of antibiotic eye drops have an effect on symptom resolution compared to placebo (artificial tears) eye drops in people with acute sinusitis?

    2. Does the use of placebo (artificial tears) eye drops have an effect on symptom resolution compared to usual care in people with acute sinusitis
    E.2.2Secondary objectives of the trial
    Does use of antibiotic eye drops have an effect on symptom resolution compared to usual care in people with acute sinusitis.

    Does use of eye drops lead to a reduction in oral antibiotic use?

    Does use of eye drops lead to a reduction in oral antibiotic prescription dispensing?

    Does use of eye drops lead to better disease-specific quality of life at 1 and 2 weeks?

    Does the use of eye drops lead to better general quality of life at 1 and 2 weeks?

    Is there a difference in use of concomitant medication?

    Is there a difference in incidence of adverse effects?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is willing and able to give informed consent for participation in the trial. This will include the ability to understand the study information in Norwegian.
    2. Male or Female, aged 18 – 64 years.
    3. Diagnosed by their GP with probable acute sinusitis, according to usual diagnostic criteria used by the GP, and according to Norwegian guidelines.
    4. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
    E.4Principal exclusion criteria
    1. Chronic sinusitis; symptoms of the current infection must not exceed four weeks. Participants with recurrent sinusitis are eligible, provided they are symptom free between episodes of sinusitis.
    2. Patients having had previous sinus surgery. Patients having had only rhinosurgery are eligible.
    3. Significant renal or hepatic impairment.
    4. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
    5. Participant with life expectancy of less than 6 months.
    6. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
    7. Patients with any of the following eye conditions:
    o Eye injury, eye surgery or laser treatment in the previous 6 months
    o Recurrent bacterial conjunctivitis (more than 2 episodes last 2 years)
    o Chronic ongoing eye infection or inflammation, including the need of steroid eye drops
    o Known allergy to any of the IMPs
    o The use of contact lenses where the patient is not willing or able to uses glasses instead of contact lenses for the IMP treatment period.

    5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes any condition in which the IMP, the artificial tears used and/or systemic phenoxymethylpenicillin is contraindicated.
    8. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is time to symptom resolution, defined as a 30% reduction in time for patients treated with
    A-Chloramphenicol eye drops compared to placebo, and
    B-Placebo eye drops compared to usual care.

    Symptom resolution is defined as the day on which all symptoms on the major symptom score (MSS) have been rated as mild (1) or none (0) for two days in a row
    E.5.1.1Timepoint(s) of evaluation of this end point
    Major Symptom Score will be measured at inclusion (day 0) and every day in a patient diary up until day 28.
    E.5.2Secondary end point(s)
    The proportion of patients reporting that they consumed one or more doses of systemic antibiotics.

    The proportion of patients redeeming a prescription for systemic antibiotics.

    Sino-nasal outcome test (SNOT-25) score.

    EQ-5D-5L score.

    Adverse events like nausea, vomiting, diarrhoea, abdominal pain, rash, eye-itching or others recorded in the patient diary
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily, in patient diary

    Registry follow-up (redeeming antibiotic prescription)

    Days 0, 7, 14 and 28 (SNOT-25 and EQ-5D-5L)
    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 No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned20
    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 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
    Once the 28-days diary of the last subject has been collected
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 400
    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 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 2021-04-14. 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 state400
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PraksisNett
    G.4.3.4Network Country Norway
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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