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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38988331
Enrollment
Unknown
Registered
2003-10-09
Start date
2003-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis media with effusion - "glue ear" Ear, Nose and Throat Otitis media

Interventions

1. Topical nasal steroid spray mometasone furoate + standard clinical management 2. Placebo nasal spray + standard clinical management

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 4-11 with bilateral otits media with effusion (B+B or B+C2 tympanograms) after 3 months of watchful waiting

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
Not provided at time of registration.—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026