Intranasal surfactant does not improve outcomes in children with otitis media: Study
USA: A recent study has suggested that intranasally administered surfactant (OP0201) does not improve clinical outcomes in young children with acute otitis media (AOM). Further studies are needed among children with persistent middle-ear effusion.
Acute otitis media is the most frequent cause for children to be prescribed antimicrobial treatment. Surfactants are naturally occurring substances that may restore the function of the eustachian tube and potentially enhance AOM resolution. Gysella B. Muniz, UPMC Children's Hospital of Pittsburgh, Primary Care Center, Pittsburgh, PA, and colleagues aimed to evaluate the safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antimicrobial agents for treating AOM in children with 6 to 24 months of age.
For this purpose, the researchers designed a phase 2a, single-center, double-blind, randomized, placebo-controlled, parallel-group clinical trial. The study included 103 children aged 6 to 24 months with AOM. They were randomized to receive either OP0201 or a placebo twice daily for 10 days. All children received amoxicillin-clavulanate 90/6.4 mg/kg per day in 2 divided doses for 10 days. The researchers managed the participants for up to 1 month.
Post randomization visits occurred between days 4 and 6 (visit 2), days 12 and 14 (visit 3), and days 26 and 30 (visit 4). Primary efficacy endpoints were resolution of a bulging tympanic membrane at visit 2 and resolution of middle-ear effusion at visit 3.
The researchers found no clinically meaningful differences between treatment groups were apparent for primary or secondary endpoints. Also, they identified no safety concerns.
"In young children with AOM, intranasally administered surfactant (OP0201) at the dose evaluated did not result in improved clinical outcomes," wrote the study authors. "Further research, including dose-ranging studies, may be warranted among children with persistent middle-ear effusion."
Reference:
The study titled, "Intranasal Surfactant for Acute Otitis Media: A Randomized Trial," is published in the journal Pediatrics.
