Do oral corticosteroids provide clinical and cost-effective symptom relief for sore throat?

• Conditions: Sore Throat; MedDRA version: 14.1Level: PTClassification code 10001093Term: Acute tonsillitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2012-004330-41-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-31
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified