Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media
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|ClinicalTrials.gov Identifier: NCT02858388|
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media With Effusion||Device: Sinuclean Nebules 45 Other: Saline solution||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: SN45
Sinuclean Nebules 45
Device: Sinuclean Nebules 45
Nebulization of solution
Placebo Comparator: Sal
Other: Saline solution
Nebulization of solution
- 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).
- Complete auditory recovery [ Time Frame: At Day 28 after start of treatment ]The auditory recovery will be measured with tonal audiometry, % of subjects recovering normal values (threshold by air between 0 and 25 dB).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858388
|San Gennaro Hospital|
|Naples, Italy, 80136|
|Principal Investigator:||Attilio Varricchio, MD||San Gennaro Hospital, Naples, Italy|