Otitis Media With EffusionPhase 4NCT03590912
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
A Phase 4 study testing Mometasone 50 Mcg/Inh Nasal Spray, Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) and Steroid Drug (prednisolone) in people with Otitis Media With Effusion, run by Lumbini Medical College at 1 site in Nepal.
Trial summary
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Mometasone 50 Mcg/Inh Nasal Spray, Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) and Steroid Drug (prednisolone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNepal
- Study dates
- 5 Sep 2018to 18 Mar 2020
- Phase
- Phase 4
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- history of mild ear ache or decreased hearing for three or more months, plus
- intact and immobile tympanic membrane by pneumatic otoscopy
- Type B tympanogram
Who cannot join
- any external ear condition that hampers visualization of tympanic membrane
- lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
Read the detailed description
Treatment groups would be:
- Cefpodoxime + oxymetaxoline drops + levocetirizine
- Fluticasone intranasal spray
- Short term oral steroids
- Wait and watch
- Conditions
- Otitis Media With Effusion
- Being tested
- Mometasone 50 Mcg/Inh Nasal Spray, Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%), Steroid Drug (prednisolone)
- 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 50 Mcg/Inh Nasal SprayDrug
Also called Metaspray nasal spray
One spray in each nostril once daily for one month
Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)Drug
Also called Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop
Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks
Steroid Drug (prednisolone)Drug
This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week.
| Study group | Role | What they receive |
|---|---|---|
| Wait and watch (Group D) | No intervention | Wait and watch for 1 month |
| Mometasone spray (Group B) | Experimental | Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given Receives: Drug: Mometasone 50 Mcg/Inh Nasal Spray |
| antibiotic + histaminic + oxymetazoline drops (Group A) | Experimental | This group will receive oral cefpodoxime (10 mg/kg/day in two divided dose for a week) plus oral histaminics and oxymetazoline drops. Standard dose of oral histaminics (levocetirizine, 1.25 mg for age below six years, 2.5 mg for older age) for a month plus oxymetazoline nasal drops (Nasivion 0.025%) for two weeks will be given Receives: Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) |
| Oral steroid (Group C) | Experimental | Patients in this group will receive one mg/kg/day of oral prednisolone (Oral steroid) in two divided dose for a week followed by half mg/kg/day in two divided dose for next one week Receives: Drug: Steroid Drug (prednisolone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non B type tympanogram
Measured: one month
Secondary outcomes (2)
cost of treatment
Measured: one month
Adverse effects
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start5 Sep 2018
- Primary completion16 Feb 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumbini Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590912
- Sponsor's protocol ID
- 143
- Status last verified
- Jun 2020
- First submitted
- 8 Jul 2018
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.
PubMed 38088821
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
- ClinicalTrials.gov ID
- NCT03590912
- Acronym / sponsor ID
- 143
- Conditions
- Otitis Media With Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lumbini Medical CollegeUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 18 Jul 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.
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
Detailed description
Treatment groups would be:
- Cefpodoxime + oxymetaxoline drops + levocetirizine
- Fluticasone intranasal spray
- Short term oral steroids
- Wait and watch
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wait and watch (Group D) | No intervention | –Wait and watch for 1 month |
| Mometasone spray (Group B) | Experimental | Drug: Mometasone 50 Mcg/Inh Nasal SprayStandard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given |
| antibiotic + histaminic + oxymetazoline drops (Group A) | Experimental | Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)This group will receive oral cefpodoxime (10 mg/kg/day in two divided dose for a week) plus oral histaminics and oxymetazoline drops. Standard dose of oral histaminics (levocetirizine, 1.25 mg for age below six years, 2.5 mg for older age) for a month plus oxymetazoline nasal drops (Nasivion 0.025%) for two weeks will be given |
| Oral steroid (Group C) | Experimental | Drug: Steroid Drug (prednisolone)Patients in this group will receive one mg/kg/day of oral prednisolone (Oral steroid) in two divided dose for a week followed by half mg/kg/day in two divided dose for next one week |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- history of mild ear ache or decreased hearing for three or more months, plus
- intact and immobile tympanic membrane by pneumatic otoscopy
- Type B tympanogram
Key exclusion criteria (2 listed)
- any external ear condition that hampers visualization of tympanic membrane
- lost to follow up
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 50 Mcg/Inh Nasal SprayAlso: Metaspray nasal sprayOne spray in each nostril once daily for one month | Drug | Mometasone spray (Group B) |
| Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)Also: Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion dropChildren in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks | Drug | antibiotic + histaminic + oxymetazoline drops (Group A) |
| Steroid Drug (prednisolone)This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week. | Drug | Oral steroid (Group C) |
Primary outcome
Non B type tympanogram
Time frame: one month
2 secondary outcomes
cost of treatment
Time frame: one month
Adverse effects
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 38088821Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone 50 Mcg/Inh Nasal Spray, Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) and Steroid Drug (prednisolone) in people with Otitis Media With Effusion, run by Lumbini Medical College at 1 site in Nepal.
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 3 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: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non B type tympanogram (time frame: one month). 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 NCT03590912, which also lists 1 linked publication.
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 19 Jun 2020.