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

NCT03491098 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Otitis Media With Effusion

Interventions

DRUG

Mometasone Furoate spray

Mometasone Furoate spray one puff in each nostril daily for 8 weeks hypertonic sea water solution spray one puff in each nostril daily for (8) weeks.

DRUG

prednisolone sodium phosphate 15mg

three times per day for 1 week then gradual withdrawal over 2 weeks

DRUG

hypertonic sea water solution spray

one puff in each nostril daily for 8 weeks

Sponsors & Collaborators

  • Muteea Mubark Salmen Bakuwiri

    lead OTHER

Principal Investigators

  • Ezzat M Saleh, Professor · Assiut University

  • Mohamed M Abd ElNaeem, doctor · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03491098 on ClinicalTrials.gov