Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000017224
Ethics application status
Approved
Date submitted
24/10/2017
Date registered
11/01/2018
Date last updated
30/08/2019
Date data sharing statement initially provided
22/01/2019
Date results provided
30/08/2019
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
None
Universal Trial Number (UTN)
U1111-1195-8206
Trial acronym
OPfAST
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
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
Anticipated
1/02/2018
Actual
1/02/2018
Date of last participant enrolment
Anticipated
1/01/2020
Actual
5/07/2019
Date of last data collection
Anticipated
5/07/2019
Actual
5/07/2019
Sample size
Target
120
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 9309 0
New Zealand
State/province [1] 9309 0
Auckland

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298876 0
Health and Disability Ethics Committee
Ethics committee address [1] 298876 0
Ethics committee country [1] 298876 0
New Zealand
Date submitted for ethics approval [1] 298876 0
09/05/2017
Approval date [1] 298876 0
18/10/2017
Ethics approval number [1] 298876 0
17/NTB/86

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78526 0
Dr Ivan Koay
Address 78526 0
Navicular 619Ltd
11D Cathedral Place
Parnell
Auckland 1052
Country 78526 0
New Zealand
Phone 78526 0
+64211556998
Fax 78526 0
Email 78526 0
[email protected]
Contact person for public queries
Name 78527 0
Ivan Koay
Address 78527 0
Silverdale Medical Centre
7 Polarity Rise
Silverdale
Auckland 0932
Country 78527 0
New Zealand
Phone 78527 0
+6492803131
Fax 78527 0
Email 78527 0
[email protected]
Contact person for scientific queries
Name 78528 0
Ivan Koay
Address 78528 0
Silverdale Medical Centre
7 Polarity Rise
Silverdale
Auckland 0932
Country 78528 0
New Zealand
Phone 78528 0
+6494279997
Fax 78528 0
Email 78528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.