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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.