Condition category
Ear, Nose and Throat
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Ian Williamson


Contact details

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
SO16 5ST
United Kingdom
+44 (0)23 8024 1071

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 01/72/02

Study information

Scientific title



Study hypothesis

Otitis Media with Effusion affects about 85% of children by the age of 10 and can lead to hearing loss and other problems such as speech delay, educational and behavioural impairments. Referral for surgery may rise in the UK when the MRC TARGET findings are published. Presently there are no effective temporizing medical managements for the majority of children with this condition, and there is a need to find alternatives to antibiotics.
The majority of effusions are associated with virus infections, and do not need treatment, so the children identified in practices will enter a 3 month period of watchful waiting before randomization. Children will be identified through case finding and targeted by audit on the basis of risk factors, before being invited for tympanometry, by validated and fully trained research nurses.

Only persistent cases on both sides (3 months) will be included. The intervention is of a topical intranasal steroid or placebo once a day for 3 months. We will gather baseline and outcome data on the major effect modifiers and perform Pure Tone Audiometry and microtympanometry. Outcomes will be at 1, 3, and 9 months, and will include the necessary measures for a health economic evaluation of effectiveness with modeling in analysis. In addition we will include the OM7-27 questionnaire developed by the MRC as a sensitive and specific measure of change and quality of life.

Protocol can be found at
More details can be found at

Please note that, as of 15 January 2008, the anticipated start and end dates of this trial have been updated from 1 June 2003 and 31 August 2007 to 1 September 2003 and 29 February 2008, respectively.

Ethics approval

Not provided at time of registration.

Study design

Double blind randomized placebo controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet


Otitis media with effusion - "glue ear"


1. Topical nasal steroid spray mometasone furoate + standard clinical management
2. Placebo nasal spray + standard clinical management

Intervention type



Not Specified

Drug names

mometasone furoate

Primary outcome measures

The primary end-point will be differences in rates of clearance of bilateral effusions in children (not ears) between treated and placebo arms at 1 month. We will be using microtympanometric assessment and the modified Jerger classification of tympanograms.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Children aged 4-11 with bilateral otits media with effusion (B+B or B+C2 tympanograms) after 3 months of watchful waiting

Participant type


Age group



Not Specified

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
SO16 5ST
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

SO17 1BJ
United Kingdom
+44 (0) 23 8059 5000

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 HTA monograph in
2. 2009 results in

Publication citations

  1. Results

    Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, Haggard M, Little P, Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial., BMJ, 2009, 339, b4984.

  2. Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, Abangma G, Dakin H, Little P, A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care., Health Technol Assess, 2009, 13, 37, 1-144, doi: 10.3310/hta13370.

Additional files

Editorial Notes