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 |
| Protocol serial number | HTA 01/72/02 |
| Sponsor | University of Southampton (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)23 8024 1071 |
|---|---|
| igw@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomized placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GNOME |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | mometasone furoate |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 29/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 11 Years |
| Sex | Not Specified |
| Key inclusion criteria | Children aged 4-11 with bilateral otits media with effusion (B+B or B+C2 tympanograms) after 3 months of watchful waiting |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 29/02/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/12/2009 | Yes | No | |
| Other publications | HTA monograph | 01/08/2009 | Yes | No |
