A double-blind randomised placebo-controlled trial of topical nasal steroids in 4-11 year old children with persistent bilateral Otitis Media with Effusion (OME) in primary care

ISRCTN ISRCTN38988331
DOI https://doi.org/10.1186/ISRCTN38988331
Secondary identifying numbers HTA 01/72/02
Submission date
08/10/2003
Registration date
09/10/2003
Last edited
05/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ian Williamson
Scientific

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone +44 (0)23 8024 1071
Email igw@soton.ac.uk

Study information

Study designDouble blind randomized placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymGNOME
Study objectivesOtitis 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedOtitis media with effusion - "glue ear"
Intervention1. Topical nasal steroid spray mometasone furoate + standard clinical management
2. Placebo nasal spray + standard clinical management
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)mometasone furoate
Primary outcome measureThe 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 measuresNot provided at time of registration.
Overall study start date01/09/2003
Completion date29/02/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit11 Years
SexNot Specified
Target number of participantsNot provided at time of registration.
Key inclusion criteriaChildren aged 4-11 with bilateral otits media with effusion (B+B or B+C2 tympanograms) after 3 months of watchful waiting
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/09/2003
Date of final enrolment29/02/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
Government

Highfield
Southampton
SO17 1BJ
United Kingdom

Phone +44 (0) 23 8059 5000
Email rgoinfo@soton.ac.uk
Website http://www.soton.ac.uk/
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications HTA monograph 01/08/2009 Yes No
Results article results 16/12/2009 Yes No