The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study (Efficacy)
|ClinicalTrials.gov Identifier: NCT03491098|
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 18, 2018
|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|
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.
- Patients previously managed by ventilation tube.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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,
- 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,
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491098
|Contact: Muteea M Bakuwairi, master||01148883026 ext AssiutUfirstname.lastname@example.org|
|Study Chair:||Ezzat M Saleh, Professor||Assiut University|
|Study Director:||Mohamed M Abd ElNaeem, doctor||Assiut University|