Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000372987
Ethics application status
Not yet submitted
Date submitted
2/04/2011
Date registered
11/04/2011
Date last updated
11/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of oral steroid tablets to help with the treatment of otitis externa (an inflammatory/infective swelling of the ear canal, also known as a 'swimmer's ear')
Scientific title
In patients with otitis externa, does the adjuvant use of oral prednisolone for three days with topical antibiotic steroid drops hasten the resolution of symptoms of otitis externa
Secondary ID [1] 259899 0
nil
Universal Trial Number (UTN)
U1111-1120-4853
Trial acronym
OE RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otits externa 265504 0
Condition category
Condition code
Ear 265656 265656 0 0
Other ear disorders
Infection 265734 265734 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adjuvant 3 day course of high dose oral steroid (dexamethasone 9mg once daily)
Intervention code [1] 264325 0
Treatment: Drugs
Comparator / control treatment
Microcellulose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 262440 0
Pain is the primary outcome. Measured with a 4 day diary of subjective pain scoring on a provided visual analogue scale (VAS). Patient is asked to rate their pain each day on the scale from the day of treatment (Day 1) till the day of follow-up (Day 4)
Timepoint [1] 262440 0
4 days after the date first seen in emergency and enrolled which will be the day of treatment.
Primary outcome [2] 262441 0
Ear canal oedema. Assessing clinician will rate the degree of oedema with 3 grades. 1) Severe (complete/near complete canal closure) 2) Moderate (some canal patency but TM not well visualised) 3) Mild (patent canal with good TM visibility)
Timepoint [2] 262441 0
4 days after the date first seen in emergency and enrolled which will be the day of treatment.
Secondary outcome [1] 273783 0
aural fullness / blockage. Patients are asked to rate the degree of aural fullness/blockage on a numerical scale on each day on a provided diary containing a visual analogue scale (in similar fashion to the pain measurement)
Timepoint [1] 273783 0
4 days after the date first seen in emergency and enrolled which will be the day of treatment.

Eligibility
Key inclusion criteria
Acute unilateral uncomplicated otitis externa
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients already on steroid tablets for other medical reasons
Patients who have bilateral disease or chronic disease
Patient who can't take steroids such as poorly controlled diabetes or peptic ulcer disease

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)
Recruited from patients presenting to emergency department for primary treatment of acute otitis externa
After obtaining informed consent, participants are given either placebo or treatment medication in a randomised fashion blind to the prescriber and dispenser. Each patient will receive a standardised local treatment which is the usual typical commonly practiced treatment that involves aural toileting, placement of a wick sponge into the ear and antibiotic/steroid ear drops. He/she is then given a separate 'trial script'. The trial script will be reviewed by a pharmacist and assigned a trial number which will be recorded with the patient detail in the data base. This trial number will be randomly picked but will be assigned to either placebo drug or steroid. Prescribing doctor and receiving participants will be blind to this allocation and drug choice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation of trial number given to each participants. This number will identify the specific medication given (placebo vs. steroid) and will be revealed to the researcher at the conclusion of the trial. This number will be generated using a standard computerised sequence generation software employed by our pharmacy department.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Standardised local therapy for both groups (all receive ear toilet, wick insertion and same ear drop + either steroid or placebo)
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264786 0
Hospital
Name [1] 264786 0
The Royal Victorian Eye and Ear Hospital
Country [1] 264786 0
Australia
Primary sponsor type
Hospital
Name
The Royal Victorian Eye and Ear Hospital
Address
32 Gisborne Street, East Melbourne, Victoria, Australia 3002
Country
Australia
Secondary sponsor category [1] 263902 0
None
Name [1] 263902 0
Address [1] 263902 0
Country [1] 263902 0
Other collaborator category [1] 251924 0
University
Name [1] 251924 0
Department of Otolaryngology, The University of Melbourne
Address [1] 251924 0
32 Gisborne Street, East Melbourne, Victoria, Australia
3002
Country [1] 251924 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266761 0
Ethics committee address [1] 266761 0
Ethics committee country [1] 266761 0
Date submitted for ethics approval [1] 266761 0
05/04/2011
Approval date [1] 266761 0
Ethics approval number [1] 266761 0

Summary
Brief summary
Otitis externa is a common ear condition. Also known as a ‘swimmer’s ear’, it often causes painful swelling of the external ear canal and may lead to sensation of blockage as well as hearing loss. It is primarily an inflammatory disease with infective component which can be bacterial or fungal in nature. Risk factors include compulsive scratching of the ear, swimming, hearing aid use and use of cotton buds. Otitis externa is typically treated with antibiotic/steroid ear drops but it is common for patients to experience symptoms of otitis externa such as pain for many days. Given that otitis externa is primarily inflammatory in nature, we propose that if patients are given a 3 day course of oral steroid tablets (anti-inflammtory drugs commonly used in many medical conditions) in addition to ear drops, it may speed up the recovery and reduce the total number of days during which patients would experience symptoms especially pain. This study would be a double-blinded and randomised-control trial in nature, meaning that both treating doctors and participating patients will not know which treatment has been given (i.e. treatment drug vs. placebo), thereby increasing the validity of the trial outcome.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32425 0
Address 32425 0
Country 32425 0
Phone 32425 0
Fax 32425 0
Email 32425 0
Contact person for public queries
Name 15672 0
Philip Michael
Address 15672 0
Royal Victorian Eye and Ear Hospital,

32 Gisborne Street, East Melbourne, Victoria, Australia 3002
Country 15672 0
Australia
Phone 15672 0
+61 3 99298333
Fax 15672 0
Email 15672 0
[email protected]
Contact person for scientific queries
Name 6600 0
Philip Michael
Address 6600 0
Royal Victorian Eye and Ear Hospital,

32 Gisborne Street, East Melbourne, Victoria, Australia 3002
Country 6600 0
Australia
Phone 6600 0
+61 3 99298333
Fax 6600 0
Email 6600 0
[email protected]

No information has been provided regarding IPD availability


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.