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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-004330-41
    Sponsor's Protocol Code Number:CH-GH/TOAST/0006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-31
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-004330-41
    A.3Full title of the trial
    Do oral corticosteroids provide clinical and cost-effective symptom relief for sore throat? A multi-centre, double blind, randomized, placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Do oral corticosteroids provide clinical and cost-effective symptom relief for sore throat?
    A.3.2Name or abbreviated title of the trial where available
    Treatment Options without Antibotics for Sore Throat (TOAST)
    A.4.1Sponsor's protocol code numberCH-GH/TOAST/0006
    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 Oxford
    B.1.3.4CountryUnited Kingdom
    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 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 Dexamethasone Tablets BP 2.0mg
    D.2.1.1.2Name of the Marketing Authorisation holderAuden Mckenzie (Pharma Division) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDexamethasone
    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 INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Sore Throat
    E.1.1.1Medical condition in easily understood language
    Sore Throat
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10001093
    E.1.2Term Acute tonsillitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate in adults 18 years and over presenting to their GP with acute sore throat, if the use of a single dose of an oral steroid, dexamethasone, compared with no steroid treatment leads to increased resolution or improvement in symptoms.
    E.2.2Secondary objectives of the trial
    1) To investigate whether dexamethasone compared with a placebo leads to increased resolution or improvement in symptoms of a sore throat in those patients who have not been prescribed antibiotics
    2) To investigate whether dexamethasone compared to placebo will, in those patients offered a delayed antibiotic prescription, reduce the number of patients taking antibiotics for their sore throat within 7 days
    3) To investigate whether a single dose of oral dexamethasone compared to placebo will:
    a) reduce time away from work or education within 7 days
    b) not increase the incidence of hospital admission with complications related to sore throat (e.g. peritonsillar abscess) within 28 days
    c) not increase repeat attendance at the GP within 28 days with symptoms or complications of sore throat
    d) be cost-effective
    4) To assess what symptoms will cause a predicted response to corticosteroids in sore throat treatment, using the FeverPAIN score, Centor score, baseline factors and posit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Aged 18 years or above
    •Presenting to a primary care appointment with acute sore throat and odynophagia (pain on swallowing) which is judged by the clinician to be infective in origin
    •Onset of symptoms within the last 7 days
    •Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the Symptom Diary
    E.4Principal exclusion criteria
    •Female participant who is pregnant, lactating or planning pregnancy during the course of the study
    •Recent (<1 month) use of inhaled or oral corticosteroids.
    •Recent (<1 month) Adenotonsillectomy
    •Currently or recently (<14 days) taking antibiotics
    •Clear alternative diagnosis e.g. pneumonia
    •Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer)
    •Scheduled elective surgery or other procedures requiring general anaesthesia during next 7 days
    •Participant who is terminally ill
    •Symptoms or signs suggesting that hospital admission is required (e.g. completely unable to swallow, very systemically unwell, peritonsillar abscess)
    •Participant judged by the GP to require immediate antibiotics
    •History of severe affective disorders including steroid-induced psychiatric illness
    •British National Formulary (BNF) listed contra-indications to oral steroids
    •Existing symptoms that are also side effects of, oral steroids
    •Patients taking other interacting medication (e.g. phenytoin and anti-coagulants). Clinicians will be asked to use the BNF and their clinical prescribing systems to check for interactions for all patients
    •Known dexamethasone allergy
    •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 study, or may influence the result of the study, or the participant’s ability to participate in the study
    •Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days
    •Recruiting primary care site is not the patients usual practice if the patient is not expecting to still be with the primary care site in one month (i.e. temporary residents)
    •Previous TOAST participation
    •Patients able to be randomised by the end of the (working) day of presentation
    •Requirement for live vaccine in next 7 days
    E.5 End points
    E.5.1Primary end point(s)
    Direct report by the patient of presence or absence of complete resolution of sore throat at 24 hours by either text message or telephone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24hours after taking medication
    E.5.2Secondary end point(s)
    1)Direct report by those patients who have not been prescribed antibiotics of presence or absence of complete resolution of sore throat at 24 hours by either text message or telephone
    2)Report of presence or absence of complete resolution of sore throat at 48 hours by either text message or telephone contact
    3)Report of time to onset of pain relief (in hours) within 7 days
    4)Report of time to complete symptom resolution (in hours) within 7 days
    5)Duration of moderately bad symptoms recorded by validated symptom diary over the 7 days from treatment onset.
    6)Severity of symptoms in the 2-4 days after seeing the doctor based on the symptom diary
    7)Change in ratings of sore throat pain and pain on swallowing by visual analogue scale
    8)Uptake of delayed antibiotic prescription within 7 days
    9)Time missed from work or education over subsequent 7 days
    10)Attendance at GP practice, A and E or Out of hours (OOH) centres within 28 days with symptoms or complications associated with sore throat e.g. peritonsillar abscess
    11)Hospital admission with related complications of sore throat within 28 days
    12)Use of over-the counter medications and prescription medications (including whether, if delayed antibiotics are taken, the course is completed, and whether any other antibiotics were taken) in the first 7 days
    13)Cost effectiveness measures: Euroqol 5D score change in 7 days and impact on usual activities over 7 days
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 24 hours after taking medication.

    2- 48 hours after taking medication.

    3,4,5,6,7,8,9,10,11,12,13- Via the Symptom Diary completed daily from days 0-7 either online or on paper.

    3,4,5,6,8,9,10,11,12- If necessary via a follow up questionnaire after 2 weeks, if the Symptom Diary has not been completed.

    10,11,12- Through a notes review at one month at their GP practice by GP practice staff.
    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 No
    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 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 concerned40
    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
    The end of trial will be once the primary outcome data has been collected for 408 patients and the one month follow-up notes review of the four hundred and eighth participant has been performed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 510
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state510
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 510
    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)
    The participants would still be able to have dexamethasone prescribed by their GP following the trial, if appropriate.
    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 Primary Care Research Network South East Thames
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-16
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