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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Oral Prednisone in Acute Sore throats
Scientific title
Use of oral prednisone in the treatment of acute sore throat - a randomised control trial
Secondary ID [1] 293193 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sore Throat 305190 0
Pharyngitis 305191 0
Condition category
Condition code
Infection 304508 304508 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
Oral Prednisone in the treatment of Acute sore throat
40mg of prednisone administered daily for 2 days against placebo tablets taken for the same period of time.
Patients will be contacted at 48 hours for symptomatic scoring and be asked to return and pain diary that will be provided to them
All patients will be swab to rule out Group A strep infection and when throat swabs are noted to be positive generally after 48 hours, these patients would be treated appropriately with antibiotics.
Intervention code [1] 299449 0
Treatment: Drugs
Comparator / control treatment
Placebo control as comparison - microcellulose tablets
Control group

Primary outcome [1] 303747 0
Assessment of sore throat pain in patients by a VAS (visual analog scale for pain) that is provided to the patient. This will be done with a follow up phone calls to the patient at 48 hours
Timepoint [1] 303747 0
Phone calls will be made at 48 hours to assess change in throat pain as assessed by VAS (visual analog scale).

Primary outcome [2] 303797 0
Symptom diary review of the time of resolution of pain symptoms that are noted by the enrolled participants.
Timepoint [2] 303797 0
Symptom diary collected after 1 week. Participants will be asked to fill the diary out of their pain symptoms on a daily basis and the diary itself collected after 1 week.
This will be a review for the time of complete resolution of the pain symptom as noted in the diary
Primary outcome [3] 303945 0
Resolution of throat pain (yes/no) as defined by a score of less than 2 on a VAS.
Timepoint [3] 303945 0
Follow up phone calls to the patient will be made of the sore throat pain symptoms with VAS scoring done at 48 hours
Secondary outcome [1] 340061 0
Time to return to normal activities as assessed by phone contact and symptom diaries collected.
Return to normal activities being defined as going back to work, school, university
Timepoint [1] 340061 0
Symptom diaries collected at 7 days
Secondary outcome [2] 340193 0
Adverse events are defined as follows:
An adverse event (AE) or adverse experience is any untoward medical occurrence in a patient or any abnormal result from a clinical investigation in participants who have been administered a medicinal product, which does not necessarily have to have a causal relationship with this treatment (the study medication). An adverse reaction (AR) will be defined as all untoward and unintended responses to a medicinal product related to any dose. A serious adverse event (SAE) will be defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability and/or incapacity, is a congenital anomaly or birth defect or other important medical events.
Timepoint [2] 340193 0
Review at 28 days by review of the patients clinical notes

Key inclusion criteria
1. Age 16 and older with sore throat occurring within the last 7 days. If they are having and have had a sore throat within the last 7 days at the time of enrolment
Minimum age
16 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Patients allergic to oral prednisone
2. Patients deemed by the examining clinician to require immediate oral antibiotics due to high suspicion of Group A Streptococcal infection based on the modified Centor/McIssac criteria (9).
3. Female participants who are pregnant or lactating
4. Participant who are at the time of assessment currently taking or in the last 14 day been administered antibiotics or steroids orally or intravenously or on long term inhaled steroids
5. Participants who are immunodeficient or immunocompromised (HIV, current chemotherapy, active malignancy), are due to have elective surgery with general anaesthesia in the following 7 days, terminally ill and those that have signs or symptoms that would require hospitalisation such as peri tonsillar abscess, unable to swallow, systemically unwell.
6. Patients with unstable diabetes or a venous or arterial ulcer on their leg.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The analysis will be done by intention to treat analysis. Categorical outcomes were expressed using counts (percentages) and compared between treatment groups using the Chi squared test. Continuous variables were expressed using mean (standard deviation) and compared between groups using an analysis of variance. Missing data at 1 week will be imputed. A two-tailed p value< 0.05 was significant. Statistical analysis was performed using SAS V.9.3 (SAS Institute Inc., Cary, North Carolina, USA).

Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 9309 0
New Zealand
State/province [1] 9309 0

Funding & Sponsors
Funding source category [1] 297822 0
Self funded/Unfunded
Name [1] 297822 0
Ivan Koay
Address [1] 297822 0
Navicular 619 Ltd.
11D Cathedral Place,
Auckland 1052.
Country [1] 297822 0
New Zealand
Funding source category [2] 297824 0
Name [2] 297824 0
Royal New Zealand College of Urgent Care
Address [2] 297824 0
110 Lunn Ave
Auckland 1072
Country [2] 297824 0
New Zealand
Primary sponsor type
Ivan Koay
Navicular 619Ltd.
11D Cathedral Place,
Auckland 1052
New Zealand
Secondary sponsor category [1] 296864 0
Name [1] 296864 0
Royal New Zealand College of Urgent Care
Address [1] 296864 0
110 Lunn Ave
Auckland 1072
Country [1] 296864 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 298876 0
Health and Disability Ethics Committee
Ethics committee address [1] 298876 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Ethics committee country [1] 298876 0
New Zealand
Date submitted for ethics approval [1] 298876 0
Approval date [1] 298876 0
Ethics approval number [1] 298876 0

Brief summary
This is a novel study to investigate the use of oral prednisone for the treatment of acute sore throat. There have been previous studies conducted that looked at steroid in the context of tonsillitis and acute pharyngitis in the past by Kiderman et. al. (2005) and Crawford-Faucher (2014). However all previous published work had patients being given concurrent antibiotics with the steroids.
We propose to perform a randomised controlled trial comparing oral prednisone to placebo where the antibiotics are withheld. Safeguards for strep throat infections will be taken in the form of throat swabbing of all our participants and where necessary, delayed antibiotics prescribed.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 78526 0
Dr Ivan Koay
Address 78526 0
Navicular 619Ltd
11D Cathedral Place
Auckland 1052
Country 78526 0
New Zealand
Phone 78526 0
Fax 78526 0
Email 78526 0
Contact person for public queries
Name 78527 0
Dr Ivan Koay
Address 78527 0
Silverdale Medical Centre
7 Polarity Rise
Auckland 0932
Country 78527 0
New Zealand
Phone 78527 0
Fax 78527 0
Email 78527 0
Contact person for scientific queries
Name 78528 0
Dr Ivan Koay
Address 78528 0
Silverdale Medical Centre
7 Polarity Rise
Auckland 0932
Country 78528 0
New Zealand
Phone 78528 0
Fax 78528 0
Email 78528 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Yet to get full data set. Still in the recruiting phase with 43 of 120 participants enrolled so far
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Other publication details
Citation type [1] 1128 0
Citation/DOI/link/details [1] 1128 0
Presentation at Goodfellow Symposium 2018
Attachments [1] 1128 0
Results – basic reporting
Results – plain English summary