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

Primary Purpose

Otitis Media With Effusion

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Mometasone Furoate spray
prednisolone sodium phosphate 15mg
hypertonic sea water solution spray
Sponsored by
Muteea Mubark Salmen Bakuwiri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effusion focused on measuring Otitis Media with Effusion

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    momestone furoate spray first group: will be given

    prednisolone sodium phosphate 15mg second group: will be given

    hypertonic sea water solution spray third group: will be given

    Arm Description

    Nasonex spray one puff in each nostril daily for 8 weeks

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

    Nasal spray one puff in each nostril daily for 8 weeks

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2018
    Last Updated
    April 17, 2018
    Sponsor
    Muteea Mubark Salmen Bakuwiri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03491098
    Brief Title
    The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
    Acronym
    Efficacy
    Official Title
    The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2018 (Anticipated)
    Primary Completion Date
    April 30, 2019 (Anticipated)
    Study Completion Date
    March 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Muteea Mubark Salmen Bakuwiri

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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: Patients previously managed by ventilation tube. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Otitis Media With Effusion
    Keywords
    Otitis Media with Effusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    momestone furoate spray first group: will be given
    Arm Type
    Placebo Comparator
    Arm Description
    Nasonex spray one puff in each nostril daily for 8 weeks
    Arm Title
    prednisolone sodium phosphate 15mg second group: will be given
    Arm Type
    Placebo Comparator
    Arm Description
    Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks
    Arm Title
    hypertonic sea water solution spray third group: will be given
    Arm Type
    Placebo Comparator
    Arm Description
    Nasal spray one puff in each nostril daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate spray
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    prednisolone sodium phosphate 15mg
    Intervention Description
    three times per day for 1 week then gradual withdrawal over 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    hypertonic sea water solution spray
    Intervention Description
    one puff in each nostril daily for 8 weeks
    Primary Outcome Measure Information:
    Title
    Clinical examination:Hearing loss
    Description
    Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
    Time Frame
    2 weeks evaluation for 2 months
    Title
    Clinical examination:Nasal obstruction
    Description
    Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
    Time Frame
    2 weeks evaluation for 2 months
    Title
    Full E.N.T history
    Description
    Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss.
    Time Frame
    2 weeks evaluation for 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muteea M Bakuwairi, master
    Phone
    01148883026
    Ext
    AssiutU
    Email
    bakuwairi2017@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ezzat M Saleh, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mohamed M Abd ElNaeem, doctor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23855103
    Citation
    Yousaf M, Inayatullah, Khan F. Medical versus surgical management of otitis media with effusion in children. J Ayub Med Coll Abbottabad. 2012 Jan-Mar;24(1):83-5.
    Results Reference
    background
    PubMed Identifier
    3932928
    Citation
    Bernstein JM, Lee J, Conboy K, Ellis E, Li P. Further observations on the role of IgE-mediated hypersensitivity in recurrent otitis media with effusion. Otolaryngol Head Neck Surg. 1985 Oct;93(5):611-5. doi: 10.1177/019459988509300508.
    Results Reference
    background
    PubMed Identifier
    2500860
    Citation
    Tomonaga K, Kurono Y, Chaen T, Mogi G. Adenoids and otitis media with effusion: nasopharyngeal flora. Am J Otolaryngol. 1989 May-Jun;10(3):204-7. doi: 10.1016/0196-0709(89)90064-1.
    Results Reference
    background
    PubMed Identifier
    9950108
    Citation
    Ho WK, Wei WI, Yuen AP, Hui Y, Wong SH. Otorrhea after grommet insertion for middle ear effusion in patients with nasopharyngeal carcinoma. Am J Otolaryngol. 1999 Jan-Feb;20(1):12-5. doi: 10.1016/s0196-0709(99)90045-5.
    Results Reference
    background
    PubMed Identifier
    1487659
    Citation
    Tang NL, Choy AT, John DG, van Hasselt CA. The otological status of patients with nasopharyngeal carcinoma after megavoltage radiotherapy. J Laryngol Otol. 1992 Dec;106(12):1055-8. doi: 10.1017/s0022215100121747.
    Results Reference
    background

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

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