drugset / Trial / NCT03491098

The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study

NCT03491098

Phase 0 Unknown 60 enrolled Muteea Mubark Salmen Bakuwiri
RandomizedParallel-groupOpen-labelTreatment

Summary

Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and symptoms of an acute infection. It is a leading cause of hearing impairment in children, and its early and proper management can avoid hearing and speech impairment, which can cause developmental delay in children.Although many conditions such as enlarged adenoids, cleft palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic, and infectious factors have also been claimed. Treatment of OME is still a controversial issue, as conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few in those studies,investigated topical intranasal steroid for OME treatment,and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation.

Timeline

Start
2018-05-15
Primary completion
2019-04-30
Completion
2020-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mometasone furoate Other / unclassified Intranasal
Comparator Prednisolone Other / unclassified 15 mg Oral