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ISRCTN
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ISRCTN38988331
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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GNOME
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Serial number at source
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HTA 01/72/02
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Double blind randomized placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Otitis media with effusion - "glue ear"
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Participants - inclusion criteria
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Children aged 4-11 with bilateral otits media with effusion (B+B or B+C2 tympanograms) after 3 months of watchful waiting
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/09/2003
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Anticipated end date
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29/02/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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1. Topical nasal steroid spray mometasone furoate + standard clinical management
2. Placebo nasal spray + standard clinical management
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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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
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Contact name
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Dr
Ian
Williamson
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Address
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Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
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City/town
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Southampton
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Zip/Postcode
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SO16 5ST
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Country
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United Kingdom
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Tel
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+44 (0)23 8024 1071
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Fax
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+44 (0)23 8070 1125
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Email
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igw@soton.ac.uk
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Sponsor
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University of Southampton (UK)
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Address
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Highfield
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City/town
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Southampton
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Zip/Postcode
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SO17 1BJ
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Country
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United Kingdom
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Tel
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+44 (0) 23 8059 5000
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Fax
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+44 (0)23 8059 3939
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Email
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rgoinfo@soton.ac.uk
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Sponsor website:
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http://www.soton.ac.uk/
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Date applied
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08/10/2003
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Last edited
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05/01/2010
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Date ISRCTN assigned
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09/10/2003
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