ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000059561

Ethics application status

Approved

Date submitted

15/12/2014

Date registered

23/01/2015

Date last updated

11/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Low dose of oral corticosteroids in the treatment of painful acute otitis externa (swimmer's ear)

Scientific title

Effect of low dose of oral corticosteroids on time to pain resolution, lost hours of normal activity and patient satisfaction in the treatment of painful acute otitis externa (swimmer's ear) in General Practice

Secondary ID [1]

Project database / registry at College of Medicine and Dentistry at James Cook University. The ID number is: 117331. Registration is available at https://au.researchweb.org/is/jcu/document/117331 (This is not the trial website).

Universal Trial Number (UTN)

U1111-1165-2370

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute otitis externa

Condition category

Condition code

Ear

Other ear disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Capsule with prednisone 10mg to take twice daily (20mg daily) for four days. When symptoms have stopped or 10 days after starting treatment with the study tablet, whichever occurs first, the patients answer a questionnaire. One of the questions are: "How many study tablets did you take?". They can tick 1-2 or 3-4 or 5-6 or 7-8.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

capsule with Lactose to take twice daily for four days

Control group

Placebo

Outcomes

Primary outcome [1]

Time (number of days) to resolution of pain using a previously validated diary (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)

Timepoint [1]

Will be measured daily up until a maximum of ten days.

Primary outcome [2]

“Lost hours” in respect of:
1) need for bed rest
2) activity limitation
3) paid work missed
4) need for paid child/elder care
Measurements by using a previously validated diary (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)

Timepoint [2]

Will be measured daily up until a maximum of ten days.

Primary outcome [3]

"Patient satisfaction" concerning:
1) burning or stinging feeling post administration of topical treatment
2) itching post administration of topical treatment
3) time to resolution of pain
4) time to resolution of itching
5) time to resolution of swelling
6) time to resolution of discharge
Measurements by using a previously validated questionnaire (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)

Timepoint [3]

Will be measured with a questionnaire when symptoms have resided or after 10 days, whichever occurs first

Secondary outcome [1]

Number of unplanned revisits to a medical practitioner. Unplanned visits will be asked for in a questionnaire designed specifically for this study.

Timepoint [1]

When symptoms have resided or after 10 days, whichever occurs first.

Secondary outcome [2]

The need for exclusion from the study due to worsening of symptoms. The need for exclusion will be known from reported adverse events.

Timepoint [2]

Patient complete their participation when symptoms have resided or after 10 days, whichever occurs first. Any adverse events during this period must be reported to the study centre.

Secondary outcome [3]

Correlation between any of the other outcomes and ethnicity. Information about ethnicity is collected using a questionnaire that was designed specifically for this study.

Timepoint [3]

Ethnicity will be asked for with a questionnaire when symptoms have resided or after 10 days, whichever occurs first using a questionnaire that was designed specifically for this study.

Secondary outcome [4]

"Patient satisfaction" concerning time to resolution of normal activities. Measurements by using a previously validated questionnaire (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)

Timepoint [4]

Will be measured with a questionnaire when symptoms have resided or after 10 days, whichever occurs first.

Eligibility

Key inclusion criteria

Patients diagnosed by their General Practitioner as having acute otitis externa and:

a) Has ear pain where VAS is at least 2.5 cm of maximum 10 cm (anchored as “moderate pain”).

b) Will be staying in Australia at least 10 days (not leaving the country within a few days).

c) Age at least 16 years.

d) Not being pregnant.

e) Seems to be cognitively intact.

f) Speak English well enough to understand instructions and consent form.

g) Has no large visual impairment that would preclude completion of the patient’s diary and questionnaire.

h) Does not have Downs syndrome.

i) Does not have obvious craniofacial abnormalities.

j) Does not have diabetes mellitus.

k) Does not have known immunodeficiency (HIV, Leukemia, etc).

l) Is not taking immunosuppressant drugs or oral corticosteroids.

m) Does not have known rupture of the tympanic membrane.

n) Does not have grommet (tympanostomy tube).

o) Does not have signs of systemic sepsis (body temperature >38.5 degrees), invasive fungal disease or perichondritis of the pinna.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) Patients experiencing moderate worsening of pain after taking two or more doses of the study tablets and still have more study tablets to take.

b) Patients experiencing severe worsening of pain while still on the study tablet.

c) Patients experiencing fever >38.5 degrees while still on the study tablet.

d) Other types of adverse events need to be evaluated case by case.

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)

A series of random numbers generated by "Research Randomizer". These random numbers were transformed to a series of X or Y.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Time to resolution of pain: The VAS in patient diary measuring pain will be used to determine the number of days until pain is almost (=10mm of max 100mm) or completely (0mm of max 100mm) gone. Groups will be compared using log rank test. Cox regression will be used in case baseline differences exist between groups. If ethnicity is of importance it will be a confounding variable in the Cox regression. Furthermore, in that situation sub analysis will be made separately for Indigenous people (although the study is not powered for this sub analysis).

Lost hours: Items 16-19 in the patient diary are summed up to a total amount of “lost hours” per patient in respect of need for bed rest, activity limitation, paid work missed and need for paid child/elder care. Effect size with 95% confidence interval is calculated. Total number of hours in each area will also be compared between groups using Mann-Whitney’s test (skewed data). Should baseline differences exist between groups we will investigate using covariance analysis.

Satisfaction with symptom resolution: Item 10-16 in the patient satisfaction questionnaire are used. We primarily intend to calculate effect size with 95% confidence interval. Secondly, we will compare groups with Mann-Whitney’s test. However, should any baseline differences exist then we will analyse with Logistic regression. In such case the outcome of the item will be dichotomised with the median value as cut off limit and used as dependent variable. Treatment and variables that differ between groups at baseline will be independent variables.

Secondary research questions: If oral steroids reduce the need for unplanned revisits or the need for exclusion due to worsening of symptoms will be analysed using Fishers exact test. The importance of ethnicity will be evaluated in the research question time to resolution of symptoms where ethnicity will be a covariate. The question if corticosteroids increase patient satisfaction concerning time to resolution of normal activities will be analysed as the other questions about patient satisfaction with symptom resolution (see above).

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

2/02/2015

Actual

28/10/2015

Date of last participant enrolment

Anticipated

Actual

19/06/2017

Date of last data collection

Anticipated

Actual

19/06/2017

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

College of medicine and Dentistry, James Cook University

Address [1]

James Cook University
Cairns Hospital
Box 902
A-Block level 2
Cairns
4870 Queensland

Country [1]

Australia

Primary sponsor type

University

Name

James Cook University

Address

James Cook University
Cairns Hospital
Box 902
A-Block level 2
Cairns
4870 Queensland

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

James Cook University Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Research Office, Room 128
Faculty Science & Engineering Building (DB17)
James Cook University
Townsville
Queensland, 4811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/09/2014

Approval date [1]

06/11/2014

Ethics approval number [1]

C16

Summary

Brief summary

Otitis externa (swimmers ear) is a frequent problem worldwide, especially in the tropics. The pain and swelling often makes proper topical treatment difficult. This study aims to evaluate the effect of oral corticosteroids (an anti-inflammatory drug) on swimmers ear.

Trial website