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
About this trial
This is an interventional treatment trial for Otitis Media With Effusion focused on measuring Otitis Media with Effusion
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.
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
NCT ID
NCT03491098
First Posted
March 24, 2018
Last Updated
April 17, 2018
Sponsor
Muteea Mubark Salmen Bakuwiri
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
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The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
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