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

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ClinicalTrials.gov Identifier: NCT03491098
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Muteea Mubark Salmen Bakuwiri, Assiut University

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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Drug: Mometasone Furoate spray Drug: prednisolone sodium phosphate 15mg Drug: hypertonic sea water solution spray Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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




Primary Outcome Measures :
  1. 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. 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,

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491098


Contacts
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Contact: Muteea M Bakuwairi, master 01148883026 ext AssiutU bakuwairi2017@gmail.com

Sponsors and Collaborators
Muteea Mubark Salmen Bakuwiri
Investigators
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Study Chair: Ezzat M Saleh, Professor Assiut University
Study Director: Mohamed M Abd ElNaeem, doctor Assiut University

Publications:
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Responsible Party: Muteea Mubark Salmen Bakuwiri, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03491098     History of Changes
Other Study ID Numbers: The Efficacy of Nasal Steroids
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muteea Mubark Salmen Bakuwiri, Assiut University:
Otitis Media with Effusion
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Mometasone Furoate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Pharmaceutical Solutions
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Dermatologic Agents
Anti-Allergic Agents