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

NCT ID: NCT03491098

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2020-03-01

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:

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.

Conditions

Otitis Media With Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

momestone furoate spray first group: will be given

Nasonex spray one puff in each nostril daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Mometasone Furoate spray

Intervention Type: DRUG

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.

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

Group Type: PLACEBO_COMPARATOR

prednisolone sodium phosphate 15mg

Intervention Type: DRUG

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

hypertonic sea water solution spray third group: will be given

Nasal spray one puff in each nostril daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

hypertonic sea water solution spray

Intervention Type: DRUG

one puff in each nostril daily for 8 weeks

Interventions

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.

Intervention Type: DRUG

prednisolone sodium phosphate 15mg

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

Intervention Type: DRUG

hypertonic sea water solution spray

one puff in each nostril daily for 8 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muteea Mubark Salmen Bakuwiri

OTHER

Sponsor Role: lead

Responsible Party

Muteea Mubark Salmen Bakuwiri

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ezzat M Saleh, Professor

Role: STUDY_CHAIR

Assiut University

Mohamed M Abd ElNaeem, doctor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Muteea M Bakuwairi, master

Role: CONTACT

bakuwairi2017@gmail.com

01148883026 ext. AssiutU

References

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.

Reference Type: BACKGROUND

PMID: 23855103 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3932928 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2500860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9950108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1487659 (View on PubMed)

Other Identifiers

The Efficacy of Nasal Steroids

Identifier Type: -

Identifier Source: org_study_id