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

• ClinicalTrials.gov Identifier: NCT03491098
• Recruitment Status: Unknown
• First Posted: April 9, 2018
• Last Update Posted: April 18, 2018
• Sponsor: Muteea Mubark Salmen Bakuwiri
• Information provided by (Responsible Party): Muteea Mubark Salmen Bakuwiri, Assiut University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Muteea Mubark Salmen Bakuwiri

Investigators

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

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Muteea Mubark Salmen Bakuwiri, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03491098
• Other Study ID Numbers: The Efficacy of Nasal Steroids
• First Posted: April 9, 2018
• Last Update Posted: April 18, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Otitis; Otitis Media; Otitis Media with Effusion; Ear Diseases; Otorhinolaryngologic Diseases; Mometasone Furoate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; 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