Intranasal Surfactant for Acute Otitis Media: A Randomized Trial
| Autor: | Alejandro Hoberman, Mary Ann Haralam, Sonika Bhatnagar, Timothy R. Shope, Judith M. Martin, Hui Liu, Janice M. Pogoda, Gysella Muniz, Nader Shaikh |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Eustachian tube Acute otitis media Amoxicillin-Potassium Clavulanate Combination Placebo law.invention Surface-Active Agents Double-Blind Method Randomized controlled trial law Internal medicine Humans Medicine Administration Intranasal Otitis Media with Effusion business.industry Infant Anti-Bacterial Agents Clinical trial Otitis Media medicine.anatomical_structure Tolerability Effusion Acute Disease Pediatrics Perinatology and Child Health Drug Therapy Combination Female Nasal administration business |
| Zdroj: | Pediatrics. 148 |
| ISSN: | 1098-4275 0031-4005 |
| DOI: | 10.1542/peds.2021-051703 |
| Popis: | BACKGROUND Acute otitis media (AOM) is the most frequent reason for children to be prescribed antimicrobial treatment. Surfactants are naturally occurring substances that may restore the eustachian tube’s function and potentially enhance resolution of AOM. METHODS This was a phase 2a, single-center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antimicrobial agents for treating AOM in young children. We randomly assigned 103 children aged 6 to 24 months with AOM to receive either OP0201 or 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. Participants were managed for up to 1 month. Postrandomization 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. RESULTS No clinically meaningful differences between treatment groups were apparent for primary or secondary endpoints. There were no safety concerns identified. CONCLUSIONS In young children with AOM, intranasally administered surfactant (OP0201) did not improve clinical outcomes. Further research may be warranted among children with persistent middle-ear effusion. |
| Databáze: | OpenAIRE |
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