Otitis Media With EffusionEarly Phase 1EfficacyNCT03491098
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
A Early Phase 1 study testing Mometasone Furoate spray, prednisolone sodium phosphate 15mg and hypertonic sea water solution spray in people with Otitis Media With Effusion, run by Muteea Mubark Salmen Bakuwiri.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Mometasone Furoate spray, prednisolone sodium phosphate 15mg and hypertonic sea water solution spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 1 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sixty patients (4-12) years aged children with OME over a period for two months.
Who cannot join
- Patients previously managed by ventilation tube.
- Those who had cleft palate.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- 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.
- Conditions
- Otitis Media With Effusion
- Being tested
- Mometasone Furoate spray, prednisolone sodium phosphate 15mg, hypertonic sea water solution spray
- Keywords
- Otitis Media with Effusion
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate sprayDrug
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 15mgDrug
three times per day for 1 week then gradual withdrawal over 2 weeks
hypertonic sea water solution sprayDrug
one puff in each nostril daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| momestone furoate spray first group: will be given | Placebo comparator | Nasonex spray one puff in each nostril daily for 8 weeks Receives: 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 Receives: 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 Receives: Drug: hypertonic sea water solution spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination:Hearing loss
Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
Measured: 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,
Measured: 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.
Measured: 2 weeks evaluation for 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start15 May 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muteea Mubark Salmen Bakuwiri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muteea Mubark Salmen Bakuwiri, Assiut University
- Investigators
- Ezzat M Saleh, Professor, Study chair, Assiut UniversityMohamed M Abd ElNaeem, doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491098
- Sponsor's protocol ID
- The Efficacy of Nasal Steroids
- Acronym
- Efficacy
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23855103Bernstein 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.
PubMed 3932928Tomonaga 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.
PubMed 2500860Ho 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.
PubMed 9950108Tang 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.
PubMed 1487659
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
- ClinicalTrials.gov ID
- NCT03491098
- Acronym / sponsor ID
- Efficacy / The Efficacy of Nasal Steroids
- Conditions
- Otitis Media With Effusion
- Keywords
- Otitis Media with Effusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Muteea Mubark Salmen BakuwiriUniversity, hospital or other
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| momestone furoate spray first group: will be given | Placebo comparator | Drug: Mometasone Furoate sprayNasonex spray one puff in each nostril daily for 8 weeks |
| prednisolone sodium phosphate 15mg second group: will be given | Placebo comparator | Drug: prednisolone sodium phosphate 15mgPredsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks |
| hypertonic sea water solution spray third group: will be given | Placebo comparator | Drug: hypertonic sea water solution sprayNasal spray one puff in each nostril daily for 8 weeks |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Sixty patients (4-12) years aged children with OME over a period for two months.
Key exclusion criteria (2 listed)
- Patients previously managed by ventilation tube.
- Those who had cleft palate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoate sprayMometasone 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. | Drug | momestone furoate spray first group: will be given |
| prednisolone sodium phosphate 15mgthree times per day for 1 week then gradual withdrawal over 2 weeks | Drug | prednisolone sodium phosphate 15mg second group: will be given |
| hypertonic sea water solution sprayone puff in each nostril daily for 8 weeks | Drug | hypertonic sea water solution spray third group: will be given |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 23855103Yousaf 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.
- Background: PubMed 3932928Bernstein 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.
- Background: PubMed 2500860Tomonaga 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.
- Background: PubMed 9950108Ho 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.
- Background: PubMed 1487659Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezzat M Saleh, Professor study chair
Assiut University
Mohamed M Abd ElNaeem, doctor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mometasone Furoate spray, prednisolone sodium phosphate 15mg and hypertonic sea water solution spray in people with Otitis Media With Effusion, run by Muteea Mubark Salmen Bakuwiri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muteea M Bakuwairi, master (01148883026 ext. AssiutU, bakuwairi2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical examination:Hearing loss (time frame: 2 weeks evaluation for 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03491098, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.