Dettagli per singolo studio

DEC-NET Serial number GB425

Published online	21/06/2005 16.24.00
Last updated	27/03/2006 11.01.09


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	01/2004 388
Major Disease (ICD9 class)	CHRONIC MUCOID OTITIS MEDIA SIMPLE OR UNSPECIFIED
Experimental drug
Mometasone Treatment regimen (dosage and duration) 50 micrograms administered to each nostril once a day for three months
Gender	Both
Age (range)	4-11 years
Eligibility criteria
Inclusion criteria
Children with persistent bilateral Otitis Media with effusion who have had it on two occassions three months apart as defined by use of Fiellau-Nikolajsens modification of Jerger's classification either B+B or B+C2 tympanograms.
Exclusion criteria
Children who are at high risk of recurrent illness (eg Cleft palate, Downs syndrome, Primary Ciliary Dyskinesia, Kartageners syndrome, other immunodeficiency states), with ventilation tubes (grommets) in place or listed for operation, taking systemic steroids in past 3 months or with poorly controlled asthma or for whom there is concern about growth, a history of frequent epistaxis or know hypersensitivity to mometasone will be excluded.
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Single blind
Purpose of study
The study aims to assess the effectiveness and costeffectiveness of topical intranasal steroids in 4-11 year olds with persistant bilateral otitis media with effusion in primary care over 1 year in a pragmatic clinical trial.
Primary outcomes
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 as determined by the modified Jerger classification
Secondary outcomes
Outcomes include audiometry, a quality of life measure specific for OME the OM8-30, reattendance rates, compliance, adverse events, growth, time off school.
Summary of study design, objectives, and ongoing research findings
A double blind randomised placebo controlled trial. The study aims to assess the effectiveness and cost effectiveness of topical intranasal steroids over 1 year in a pragmatic clinical trial. The aim is to build a health economic model of total health care utilisation costs for an affected cohort of children, where such an intervention to be applied to identifiable children at feasible stages in the health care system. The target condition is persistent bilateral Otitis Media with Effusion (OME) and children with proven persistent effusions in the primary care setting will be invited for randomisation into the trial. The analysis will be intention to treat, with children rather than ears as the unit of analysis. Setting: we will utilise the Medical Research Council General Practice Research Framework (GPRF) to ensure quality and will recruit from 60 practices throughout the UK to achieve generaliseability of the trial. Target population: children aged 4-11 on the lists of practices, identified by regular audit of records (with invitation) and new consultations, with evidence of bilateral OME on tympanometry on two occasions 3 months apart using a modified Jerger classification (B+B, B+C2). Patients will be randomised to either placebo or topical intranasal steroids once a day. Intranasal Mometasone 50g is the active treatment administered to both nostrils once daily for three months. Mometasone has low systemic absorption and it is not epected to give any side-effects, however to be safe participants height and weight will be monitored regularily. Practice research nurses will be trained and validated in the specific use of the audiometric equipment required for the study. Feasibility and recruitment will be assessed over the first study winter period. The main outcome measure is tympanometric resolution at 1 month, 3 months and 9 months. Other outcomes include audiometry, a quality of life measure specific for OME the OM8-30, reattendance rates, compliance, adverse events, growth, time off work/school. Sample size: 388 see below. We will recruit from 60 practices over the first 3 years and follow up for 1 year, and complete analysis by the end of the 4th year. The primary end point is the proportion of children cleared of bilateral effusions at 1 month as determined by microtympanometry using Jergers modified criteria.