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

April 17, 2018 updated by: Muteea Mubark Salmen Bakuwiri
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess the efficacy of nasal steroids in management of OME by comparing its results with that of oral steroids and that of nasal saline spray.

Sixty patients (4-12) years aged children with OME over a period for two months will be included in this study. Informed written consent will obtained from the parents of patient studied after explanation of the research purpose.

Patient diagnosed clinically to have OME with type B tympanogram and conductive hearing loss will be enrolled in our study.

Exclusion criteria:

  1. Patients previously managed by ventilation tube.
  2. Those who had cleft palate. The patients were divided into three equal groups. In group 1, 20 patients will be received steroids spray, for. 2 months In group 2, 20 patients will be received steroids for 1 month In group 3, 20 patients will be receive hypertonic sea water solution Otoscopic examination, basic audiological evaluation including pure tone audiometry, and immittancemetry will be performed before treatment and repeated at 3 and 6 months after treatment. The evaluation was performed using ORBITR 922 VERSION2 . Examiners will be blinded to the type of treatment.

Tympanometry results were distinguished into four grades as classified by El-Anwar et al12: type A, normal curve (pressure 50/_99 H2O); type C1 (negative pressure _100/_199 mm H2O); type C2 (negative pressure _200/_394 mm H2O); type B (flat curve).2,3,11 The average hearing thresholds at 500 Hz and 1, 2, and 4 kHz were used in the statistical comparison.

Follow-up clinical examinations were done once per week for 3 weeks, at the end of treatment. The efficacy of nasal steroid for management of OME was compared with that of oral steroid and that of nasal sinomarin spray as placebo.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sixty patients (4-12) years aged children with OME over a period for two months.

Exclusion Criteria:

  • Patients previously managed by ventilation tube.
  • Those who had cleft palate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: momestone furoate spray first group: will be given
Nasonex spray one puff in each nostril daily for 8 weeks
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.
Placebo Comparator: prednisolone sodium phosphate 15mg second group: will be given
Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks
Drug: prednisolone sodium phosphate 15mg
three times per day for 1 week then gradual withdrawal over 2 weeks
Placebo Comparator: hypertonic sea water solution spray third group: will be given
Nasal spray one puff in each nostril daily for 8 weeks
Drug: hypertonic sea water solution spray
one puff in each nostril daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical examination:Hearing loss
Time Frame: 2 weeks evaluation for 2 months
Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
2 weeks evaluation for 2 months
Clinical examination:Nasal obstruction
Time Frame: 2 weeks evaluation for 2 months
Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
2 weeks evaluation for 2 months
Full E.N.T history
Time Frame: 2 weeks evaluation for 2 months
Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss.
2 weeks evaluation for 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muteea Mubark Salmen Bakuwiri

Investigators

  • Study Chair: Ezzat M Saleh, Professor, Assiut University
  • Study Director: Mohamed M Abd ElNaeem, doctor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

March 31, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Efficacy of Nasal Steroids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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