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

NCT03491098 | Unknown Early Phase 1 DMC

• 1 other identifier: The Efficacy of Nasal Steroids
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Otitis Media With Effusion

Keywords

Otitis Media with Effusion

Outcome Measures

Primary Outcomes (3)

• Clinical examination:Hearing loss

  Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,

  2 weeks evaluation for 2 months

• Clinical examination:Nasal obstruction

  Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,

  2 weeks evaluation for 2 months

• Full E.N.T history

  Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss.

  2 weeks evaluation for 2 months

Study Arms (3)

momestone furoate spray first group: will be given

PLACEBO COMPARATOR

Nasonex spray one puff in each nostril daily for 8 weeks

Drug: Mometasone Furoate spray

prednisolone sodium phosphate 15mg second group: will be given

PLACEBO COMPARATOR

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

Drug: prednisolone sodium phosphate 15mg

hypertonic sea water solution spray third group: will be given

PLACEBO COMPARATOR

Nasal spray one puff in each nostril daily for 8 weeks

Drug: hypertonic sea water solution spray

Interventions

Mometasone Furoate spray 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.

momestone furoate spray first group: will be given

prednisolone sodium phosphate 15mg DRUG

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

prednisolone sodium phosphate 15mg second group: will be given

hypertonic sea water solution spray DRUG

one puff in each nostril daily for 8 weeks

hypertonic sea water solution spray third group: will be given

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sixty patients (4-12) years aged children with OME over a period for two months.

You may not qualify if:

• Patients previously managed by ventilation tube.
• Those who had cleft palate.

Sponsors & Collaborators

• Muteea Mubark Salmen Bakuwiri: lead

Related Publications (5)

• 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.

  PMID: 23855103 BACKGROUND

• 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.

  PMID: 3932928 BACKGROUND

• 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.

  PMID: 2500860 BACKGROUND

• 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.

  PMID: 9950108 BACKGROUND

• 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.

  PMID: 1487659 BACKGROUND

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

prednisolone phosphate

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ezzat M Saleh, Professor

  Assiut University

  STUDY CHAIR

• Mohamed M Abd ElNaeem, doctor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Muteea M Bakuwairi, master

CONTACT

01148883026; bakuwairi2017@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 9, 2018
• Study Start: May 15, 2018
• Primary Completion: April 30, 2019
• Study Completion: March 1, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share