Otitis Media With EffusionPhase 3NCT02858388
Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media
A Phase 3 study testing Sinuclean Nebules 45 and Saline solution in people with Otitis Media With Effusion, run by Galsor S.r.l. at 1 site in Italy.
Trial summary
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media, comparing with saline. Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg, extracted from Ecballium Elaterium. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Sinuclean Nebules 45 and Saline solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 3
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented diagnosis of mono or bi-lateral exudative otitis media, performed the day of recruitment or in the week before, with endotympanic effusion present for at least 3 months, and hearing loss.
- The diagnostic criteria is type B tympanogram for at least one of the two ears.
- The criteria is integrated by a) tonal audiometry to demonstrate bilateral or monolateral deficit (loss of more than 20dB averaged to 0.5-1.2 and 4Khz in the best ear with pure tone audiometry); for 1-3 yo subjects the audiometry is behavioural b) otorhinolaryngologic examination in endoscopy for the otologic, rhino-sinusal and pharyngeal districts.
Who cannot join
- Outcomes of adenotonsillectomy
- Velo-palatal insufficiencies, cleft lip and cleft palate.
- Hearing loss of perceptual, and mixed type.
- Clinical conditions (systemic diseases or other) that may interfere with the evaluation of safety and clinical effectiveness of the product under investigation, for example: diabetes mellitus, heart disease, chronic renal failure, active systemic infections)
- Assumption, during the study of drugs that may interfere with the assessment of the product object of clinical investigation.
- Possibility of needing treatment during the study with drugs that are not allowed, for example: antibiotics in long-term prophylaxis, immunosuppressants, corticosteroids.
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- Regular intake of steroids in the four weeks preceding the date of the admission visit.
- Viral or allergic rhinitis, with active effusion.
- Down Syndrome
- Diagnosis of immotile cilia syndrome
- Condition of immune deficiency disease or otherwise.
- Cystic Fibrosis.
- Dental malocclusion
- Other diseases of other organ systems, which, in the opinion of the investigator, may interfere with the purpose or the study procedures.
- Not vaccinated subjects, with no clinical history of varicella who have been in contact, in the 4 weeks before the admission visit, with people who may be suffering from chicken pox or Zoster.
- Psychic condition incompatible with participation in the research.
- History of intolerance or allergy to the components of Sinuclean Nebules.
- Medical and surgical intervention that may prejudice the complete execution of the trial, in the 4 weeks preceding the signing of informed consent.
- Imminence of a medical-surgical procedure that can jeopardize the completion of the trial.
- Participation in the course to other clinical investigations, or terminated within 30 days of the start of this trial.
- Previous randomization in the study
- Be first- or second-grade relative of a member of the Site study staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Sinuclean Nebules 45 (Class 1 Medical Device) in the Treatment of Pediatric Exudative Otitis Media, Randomized, Double Blind, Comparative, Parallel Study
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media, comparing with saline.
Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg, extracted from Ecballium Elaterium.
Read the detailed description
Eligible pediatric subjects with diagnosis of mono or bi-lateral exudative otitis media (obtained with otorhinolaryngologic endoscopic examination, tympanogram and tonal audiometry), are randomized to treatment with Sinuclean Nebules 45 or saline.
Treatment is administered by trained caregiver with nebulizer (Rinowash Nasal Shower): one nebulization/nostril/day for two cycles of 10 consecutive days. Cycles are interrupted by a period of 7 days.
Visits 1 Baseline T0: confirmation of eligibility, randomization, training of caregiver, dispensation of blinded therapy for two cycles, delivery of the clinical diary.
Visit 2 after 10 days of therapy + 7 days of interval: phone call to check for adverse events, therapy adherence, concomitant diseases and treatments, and to prescribe second cycle of therapy.
Visit 3 End of Study: assessment of the exudative otitis media with otorhinolaryngologic endoscopic examination, tympanogram tonal audiometry, verification of the subject's clinical diary.
- Conditions
- Otitis Media With Effusion
- Being tested
- Sinuclean Nebules 45, Saline solution
- Keywords
- Otitis Media with Effusion, Exudative otitis media
- 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.
Sinuclean Nebules 45Device
Nebulization of solution
Saline solutionOther
Nebulization of solution
| Study group | Role | What they receive |
|---|---|---|
| SN45 | Active comparator | Sinuclean Nebules 45 Receives: Device: Sinuclean Nebules 45 |
| Sal | Placebo comparator | Saline solution Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of tympanic effusion
The resolution of the tympanic effusion will be assessed with tympanogram (% of subjects with type A tympanogram).
Measured: At Day 28 after start of treatment
Secondary outcomes (1)
Complete auditory recovery
The auditory recovery will be measured with tonal audiometry, % of subjects recovering normal values (threshold by air between 0 and 25 dB).
Measured: At Day 28 after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galsor S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor
- Investigators
- Attilio Varricchio, MD, Principal investigator, San Gennaro Hospital, Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858388
- Sponsor's protocol ID
- OME01-2014
- Status last verified
- Aug 2016
- First submitted
- 26 Jun 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zielhuis GA, Straatman H, Rach GH, van den Broek P. Analysis and presentation of data on the natural course of otitis media with effusion in children. Int J Epidemiol. 1990 Dec;19(4):1037-44. doi: 10.1093/ije/19.4.1037.
PubMed 2083987
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sinuclean Nebules 45 (Class 1 Medical Device) in the Treatment of Pediatric Exudative Otitis Media, Randomized, Double Blind, Comparative, Parallel Study
- ClinicalTrials.gov ID
- NCT02858388
- Acronym / sponsor ID
- OME01-2014
- Conditions
- Otitis Media With Effusion
- Keywords
- Otitis Media with Effusion, Exudative otitis media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Galsor S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Aug 2016 (estimated)
- 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.
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media, comparing with saline.
Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg, extracted from Ecballium Elaterium.
Detailed description
Eligible pediatric subjects with diagnosis of mono or bi-lateral exudative otitis media (obtained with otorhinolaryngologic endoscopic examination, tympanogram and tonal audiometry), are randomized to treatment with Sinuclean Nebules 45 or saline.
Treatment is administered by trained caregiver with nebulizer (Rinowash Nasal Shower): one nebulization/nostril/day for two cycles of 10 consecutive days. Cycles are interrupted by a period of 7 days.
Visits 1 Baseline T0: confirmation of eligibility, randomization, training of caregiver, dispensation of blinded therapy for two cycles, delivery of the clinical diary.
Visit 2 after 10 days of therapy + 7 days of interval: phone call to check for adverse events, therapy adherence, concomitant diseases and treatments, and to prescribe second cycle of therapy.
Visit 3 End of Study: assessment of the exudative otitis media with otorhinolaryngologic endoscopic examination, tympanogram tonal audiometry, verification of the subject's clinical diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SN45 | Active comparator | Device: Sinuclean Nebules 45Sinuclean Nebules 45 |
| Sal | Placebo comparator | Other: Saline solutionSaline solution |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Documented diagnosis of mono or bi-lateral exudative otitis media, performed the day of recruitment or in the week before, with endotympanic effusion present for at least 3 months, and hearing loss.
- The diagnostic criteria is type B tympanogram for at least one of the two ears.
- The criteria is integrated by a) tonal audiometry to demonstrate bilateral or monolateral deficit (loss of more than 20dB averaged to 0.5-1.2 and 4Khz in the best ear with pure tone audiometry); for 1-3 yo subjects the audiometry is behavioural b) otorhinolaryngologic examination in endoscopy for the otologic, rhino-sinusal and pharyngeal districts.
Key exclusion criteria (22 listed)
- Outcomes of adenotonsillectomy
- Velo-palatal insufficiencies, cleft lip and cleft palate.
- Hearing loss of perceptual, and mixed type.
- Clinical conditions (systemic diseases or other) that may interfere with the evaluation of safety and clinical effectiveness of the product under investigation, for example: diabetes mellitus, heart disease, chronic renal failure, active systemic infections)
- Assumption, during the study of drugs that may interfere with the assessment of the product object of clinical investigation.
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 |
|---|---|---|
| Sinuclean Nebules 45Nebulization of solution | Device | SN45 |
| Saline solutionNebulization of solution | Other | Sal |
Primary outcome
Resolution of tympanic effusion
Time frame: At Day 28 after start of treatment
The resolution of the tympanic effusion will be assessed with tympanogram (% of subjects with type A tympanogram).
1 secondary outcome
Complete auditory recovery
Time frame: At Day 28 after start of treatment
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 8 Aug 2016.
- Background: PubMed 2083987Zielhuis GA, Straatman H, Rach GH, van den Broek P. Analysis and presentation of data on the natural course of otitis media with effusion in children. Int J Epidemiol. 1990 Dec;19(4):1037-44. doi: 10.1093/ije/19.4.1037.
- 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.
Attilio Varricchio, MD principal investigator
San Gennaro Hospital, Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sinuclean Nebules 45 and Saline solution in people with Otitis Media With Effusion, run by Galsor S.r.l. at 1 site in Italy.
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 22 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 8 Aug 2016. 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 Italy. 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. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Resolution of tympanic effusion (time frame: At Day 28 after start of treatment). 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 NCT02858388, 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 8 Aug 2016.