Condition category
Ear, Nose and Throat
Date applied
08/10/2003
Date assigned
09/10/2003
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Williamson

ORCID ID

Contact details

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1071
igw@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/72/02

Study information

Scientific title

Acronym

GNOME

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 http://www.hta.ac.uk/protocols/200100720002.pdf
More details can be found at http://www.hta.ac.uk/1352

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Otitis media with effusion - "glue ear"

Intervention

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

Intervention type

Drug

Phase

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

01/09/2003

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/09/2003

Recruitment end date

29/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0) 23 8059 5000
rgoinfo@soton.ac.uk

Sponsor type

Government

Website

http://www.soton.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 http://www.ncbi.nlm.nih.gov/pubmed/19671372
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20015903

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