1. The INFLATE Trial
A multi-centre randomised controlled trial to compare nasal balloon autoinflation versus no nasal balloon autoinflation for bilateral otitis media with effusion in Aboriginal and Torres Strait Islander children
Penny Abbott & Shavaun Wells for the INFLATE team
19th International Symposium on
Recent Advances in Otitis Media
6/6/2017

2. The INFLATE team Western Sydney University, Sydney, NSW.
A: Dr Penelope Abbott 1
B: Prof Jennifer Reath 1
C: Dr Hasantha Gunasekera 2
D: Prof Amanda Leach 3
E: A/Prof Kelvin Kong 4
F: A/Prof Deborah Askew 5,6
G: A/Prof Federico Girosi 1
H: Prof Wendy Hu 1
I: Prof Timothy Usherwood 2
J: Ms Sanja Lujic 7
Ms Robyn Wash 1
Prof Peter Morris 3
Dr Chelsea Bond 6
Dr Geoffrey Spurling 5,6
Ms Sissy Tyson 5
Ms Samantha Harkus 8
Dr Nadeem Siddiqui, Ms Shavaun Wells, Mr Reeion Murray, Ms Emily Jennings 9
Ms Tallulah Lett, Ms Cheryl Woodall, Ms Natasha Peter 10
Mr Paul Hussein, Ms Kate Lousick 11
Ms Cheryl Sidhom, Ms Letitia Campbell 12
Ms Nicole King, Ms Vicki Bradley, Ms Julianne Abood 1
Western Sydney University, Sydney, NSW.
University of Sydney, Sydney, NSW.
Menzies School of Health Research, Darwin, NT.
University of Newcastle, Newcastle, NSW.
Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Queensland Health, Brisbane, Qld.
University of Queensland, Brisbane, Qld.
University of New South Wales, Sydney, NSW.
Australian Hearing, Macquarie Park, NSW.
Winnunga Nimmityjah Aboriginal Medical Service, Canberra, ACT.
Tharawal Aboriginal Corporation, Sydney, NSW.
Yerin Aboriginal Health Services Incorporated, Wyong, NSW.
Kalwun Development Corporation, Gold Coast, Qld.

3. Nasal Balloon autoinflation
Otovent
Available through pharmacies over the counter in Australia, cost approx. $30 AUD
Promoted by Royal Australian College of General Practitioners for age 3 and up as evidence-based care
blow up a balloon through each nostril 3 times a day
aims to promote fluid drainage from the middle ear

4. Background Bilateral OME Nasal balloon autoinflation
significant clinical problem
high prevalence in Aboriginal and Torres Strait Islander children
Nasal balloon autoinflation
Williamson et al (CMAJ 2015)
children aged 4-11 with OME in at least 1 ear (320 participants)
recruited from general practices in the UK
those receiving autoinflation more likely to have normal tympanograms at 3 months (adjusted RR 1.37, 95% CI 1.03 to 1.83)
2013 Cochrane review (Perera et al)
Pooled estimates from 8 studies (702 participants) favoured the intervention for composite outcome but did not show significant effect on tympanometry

5. Setting
Aboriginal health services in our ear health clinical trial network
Currently 5 sites, aiming to expand to 7
In Brisbane, Canberra, Sydney and Gold Coast
Have been working together since 2013 on the WATCH trial
Comparing watchful waiting with immediate antibiotic treatment for AOM
Site based Research Officers, Associate Investigators and Community Reference Groups

6. Winnunga Nimmityjah Aboriginal Medical Service, Canberra

8. Primary objective
To determine whether, in Aboriginal and Torres Strait Islander children with bilateral OME aged 3 to 16 years, nasal balloon autoinflation compared to no nasal balloon autoinflation increases the resolution of bilateral OME at 3 months.

9. Eligibility criteria I N C L U S I O N C R I T E R I A
Aboriginal and Torres Strait Islander
Aged years
Bilateral OME (defined by Type B tympanograms)
EXCL U S I O N C R I T E R I A
Current acute upper respiratory infection
Current AOM (defined by type B tymp + pain and/or bulge)
Current perforation or grommet
Latex allergy
A nosebleed in the last 3 weeks, or > 1 in preceding 6 months
A condition which increases the risk of complications (e.g. cleft palate)
Inability to use the autoinflation device
Booked ear surgery

10. Intervention Intervention Standard care
use Otovent 3xday until Month 1
At Month 1 check tympanometry
→ if still bilateral OME (B or C2) use Otovent until Month 3 visit
→ If OME resolved in 1 or both ears cease Otovent
Standard care
observation then audiology at Month 3 / referral to ENT surgeon if bilateral OME or abnormal hearing

11. Outcomes Primary Outcome: Secondary Outcomes:
The proportion of children with bilateral OME at Month 3* as measured by Type B or C2 tympanogram.
Secondary Outcomes:
The proportion of children with bilateral OME at Months 1 and 6*
Average hearing levels at Month 3*
Ear-related quality of life and health (OMQ14 questionnaire)
Adverse events
Adherence to autoinflation
Medical and non-medical costs of OME and its treatment
Qualitative exploration of parent/carer, health care provider, research officer and site community reference group perspectives of OME, nasal balloon autoinflation and research experience
* acceptable ranges: Month 1 ± 1 week; Months 3 and 6 (-2 to +6 weeks)

12. Analysis – primary outcome
Sample size 322
161 in each study group
To detect an absolute difference of 15% between groups in OME resolution rates at Month 3, with 90% power and a 5% significance level
The 15% difference =
difference between 70% resolution in the control group and 85% in the treatment group
clinically significant as the 30% non resolution would be halved
379 children randomised, allowing for 15% loss to follow up
Stratified by age (3-6; 7-16) and site
Intention to treat analysis

13. Conclusion
Potentially a low cost, non-surgical alternative for a significant clinical problem in Aboriginal and Torres Strait Islander children
Will allow further development of our clinical trial network in childhood ear disease in Aboriginal health services
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