Condition category
Ear, Nose and Throat
Date applied
06/12/2012
Date assigned
07/12/2012
Last edited
15/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Otitis media, also known as glue ear, is a common condition, especially in young children. Whilst we know that glue ear often gets better by itself, thousands of children each year experience prolonged hearing loss, which can lead to further problems. If hearing loss lasts longer than 3 months, children are usually offered hearing aids or a grommet operation. Several small research studies have suggested that treatment with oral steroids might help glue ear get better quicker. Oral steroids reduce inflammation in the body and are often used to treat conditions like asthma. However, the research done so far is not as good as we would like it to be, so we still can’t say for definite whether a child with glue ear will benefit from treatment (e.g. improved hearing, glue ear gets better, no longer needs an operation for grommets) with an oral steroid. We want to answer these questions by testing the use of oral steroids (prednisolone sodium phosphate) in a research study being run from Cardiff University.

Who can participate?
Children aged between 2 to 8 years who have been referred to an Ear, Nose and Throat (ENT) outpatient clinic with symptoms of hearing loss due to glue ear for at least 3 months.

What does the study involve?
The study involves visiting the ENT clinic for a hearing assessment and taking home a short course of oral steroids to be given to the child once a day for 7 days, by dissolving it in liquid. We also ask parents to complete a diary recording their child’s symptoms and any additional healthcare consultations their child has had over the subsequent 5 weeks. There will be follow up assessments at the ENT clinic at 5 weeks, 6 and 12 months.

What are the possible benefits and risks of participating?
A possible benefit of this study is that there may be a possibility that if the treatment works, the child’s hearing will improve so that they will no longer need hearing aids or grommet surgery. In addition, the child will also have extra assessments and monitoring in the ENT clinic, which may be helpful. Participants in this study will be helping us answer questions about the treatment of glue ear in children that should result in better care for children with this condition in the future. Taking part in the study will mean giving up some time. There is a chance that the child might develop side effects from the study treatment. However, side effects are uncommon with these treatments (especially when only taken for short periods of time), and are not usually serious.

Where is the study run from?
University Hospital of Wales (lead site) and nineteen hospitals in England and Wales (UK)

When is the study starting and how long is it expected to run for?
September 2013 to September 2015

Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Cherry-Ann Waldron
Waldronc@cardiff.ac.uk

Trial website

http://www.ostrich-study.co.uk

Contact information

Type

Scientific

Primary contact

Dr Nick Francis

ORCID ID

Contact details

Cardiff University
Institute of Primary Care and Public Health
School of Medicine
5th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Additional identifiers

EudraCT number

2012-005123-32

ClinicalTrials.gov number

Protocol/serial number

HTA 11/01/26; SPON1030-11

Study information

Scientific title

A randomised double blind placebo controlled clinical trial using oral steroids for the resolution of otitis media with effusion (OME) in children

Acronym

OSTRICH

Study hypothesis

To determine the clinical and cost effectiveness of a 7-day course of oral prednisolone (steroid) on improving hearing loss over the short term in children with bilateral OME, as diagnosed at an ENT outpatient clinic, who have had symptoms attributable to OME present for at least 3 months, and current significant hearing loss (demonstrated by audiometry).

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/110126
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0019/81145/PRO-11-01-26.pdf

Ethics approval

Wales Research Ethics Committee, 13/01/2013 ref: 13/WA/0004

Study design

Randomised double-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.ostrich-study.co.uk/parents.php

Condition

Otitis Media with Effusion (OME) or glue ear

Intervention

A 7-day course of oral soluble Prednisolone, as a single daily dose of 20mg for children aged 2-5 years or 30mg for 6-8 year olds and a matched placebo in the control group.

Intervention type

Drug

Phase

Not Applicable

Drug names

Prednisolone

Primary outcome measures

Acceptable hearing at five weeks from randomisation (four weeks after conclusion of treatment), where acceptable hearing is defined as ‘less than 20 dB averaged at 0.5, 1, 2 and 4 kHz in at least one ear in children aged 3-8 years, and less than 25 dB averaged at 0.5, 1, 2 and 4 KHz by sound field VRA in children aged under 3 years. These thresholds are based on national guidelines.

Secondary outcome measures

Current secondary outcome measures as of 17/12/2012:
1. Satisfactory hearing at 6 and 12 months, measured as above,
2. Tympanometry (using calibrated standardised tympanometers and modified Jeger classification Types B and C2)
3. Otoscopic findings
4. Healthcare consultations related to OME, and other resource use
5. Grommet surgery at 6, and 12 months
6. Adverse effects
7. Symptoms (reported by parent and/or child)
8. Functional health status (OM8-30)
9. Health related quality of life (PedsQL and HUI3)
10. Short and longer term cost effectiveness

Previous secondary outcome measures until 17/12/2012:
1. Satisfactory hearing at 3, 6, and 12 months, measured as above,
2. Tympanometry (using calibrated standardised tympanometers and modified Jeger classification Types B and C2)
3. Otoscopic findings
4. Healthcare consultations related to OME, and other resource use
5. Grommet surgery at 3, 6, and 12 months
6. Adverse effects
7. Symptoms (reported by parent and/or child)
8. Functional health status (OM8-30)
9. Health related quality of life (PedsQL and HUI3)
10. Short and longer term cost effectiveness

Overall trial start date

01/03/2013

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 2-8 years (reached 2nd birthday and not yet reached 9th birthday),
2. Had symptoms of hearing loss attributable to OME for at least 3 months (or had audiometry proven hearing loss for at least 3 months),
3. Diagnosis of bilateral OME made in an ENT clinic on the day of recruitment or during the preceding week,
4. Audiometry confirming hearing loss of more than 20 dB averaged at 0.5, 1, 2, and 4 KHz in the better ear by pure tone audiometry in children 3 years of age or more or hearing loss of more than 25 dB averaged over 0.5, 1, 2, and 4 KHz by sound field visual reinforcement audiometry (VRA) in children less than 3 years of age, on the day of recruitment or in the preceding week.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

380

Participant exclusion criteria

Current exclusion criteria as of 17/12/2012:
1. Children with cleft palate,
2. Children with Down’s syndrome,
3. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities),
4. Children with current systemic infection,
5. Children with renal failure, hypertension or congestive heart failure,
6. Children with diabetes mellitus,
7. Children who have taken oral steroids in the preceding four weeks,
8. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised),
9. Children with no prior history of Varicella (Chicken Pox) infection or immunisation and who have been in close contact with someone known or suspected to have Varicella or active Zoster (Shingles) during the three weeks prior to recruitment,
10. Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months.

Previous exclusion criteria until 17/12/2012:
1. Children with cleft palate
2. Children with Down’s syndrome
3. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities)
4. Children who have taken oral steroids in the preceding four weeks
5. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised including insulin dependent diabetes mellitus)
6. Children with no prior history of Varicella (Chicken Pox) infection or immunisation and who have been in close contact with someone known or suspected to have Varicella or active Zoster (Shingles) during the three weeks prior to recruitment

Recruitment start date

18/03/2014

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Ynysmaerdy
Pontyclun
CF72 8XR
United Kingdom

Trial participating centre

Glangwili General Hospital
Dolgwili Road
Carmarthen
SA31 2AF
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Singleton Hospital
Sketty Lane Sketty
Swansea
SA2 8QA
United Kingdom

Trial participating centre

Princess of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

The GEM Centre
Neachells Lane
Wolverhampton
WV11 3PG
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

Tunbridge Wells Hospital
Tonbridge Road
Tunbridge Wells
TN2 4QJ
United Kingdom

Trial participating centre

Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Trial participating centre

Royal National Throat, Nose and Ear Hospital
330 Gray's Inn Road
London
WC1X 8DA
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

St Mary's Hospital
Parkhurst Road Newport
Isle of Wight
PO30 5TG
United Kingdom

Trial participating centre

East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Walsall Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Worcester Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

University/education

Website

http:www.cardiff.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment - HTA (UK) ref: HTA 11/01/26

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26931619

Publication citations

Additional files

Editorial Notes

09/09/2016: The publication and dissemination plan, availability of participant level data and trial participating centres have been added. 08/09/2016: The overall trial dates have been updated from 01/09/2013 - 01/09/2015 to 01/03/2013 - 01/09/2017 and the recruitment dates have been updated from 01/09/2013 - 01/09/2015 to 18/03/2014 - 31/03/2016. 02/03/2016: Publication reference added.