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

Muteea Mubark Salmen Bakuwiri

Status and phase: Unknown; Early Phase 1

Conditions: Otitis Media With Effusion

Treatments: Drug: prednisolone sodium phosphate 15mg; Drug: Mometasone Furoate spray; Drug: hypertonic sea water solution spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03491098

The Efficacy of Nasal Steroids

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

momestone furoate spray first group: will be given

Placebo Comparator group

Description:

Nasonex spray one puff in each nostril daily for 8 weeks

Treatment:

Drug: Mometasone Furoate spray

prednisolone sodium phosphate 15mg second group: will be given

Placebo Comparator group

Description:

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

Treatment:

Drug: prednisolone sodium phosphate 15mg

hypertonic sea water solution spray third group: will be given

Placebo Comparator group

Description:

Nasal spray one puff in each nostril daily for 8 weeks

Treatment:

Drug: hypertonic sea water solution spray