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Trial record 26 of 434 for:    OTITIS

Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02858388
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Galsor S.r.l.

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Device: Sinuclean Nebules 45 Other: Saline solution Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: SN45
Sinuclean Nebules 45
Device: Sinuclean Nebules 45
Nebulization of solution

Placebo Comparator: Sal
Saline solution
Other: Saline solution
Nebulization of solution

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Outcomes of adenotonsillectomy
  2. Velo-palatal insufficiencies, cleft lip and cleft palate.
  3. Hearing loss of perceptual, and mixed type.
  4. 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)
  5. Assumption, during the study of drugs that may interfere with the assessment of the product object of clinical investigation.
  6. Possibility of needing treatment during the study with drugs that are not allowed, for example: antibiotics in long-term prophylaxis, immunosuppressants, corticosteroids.
  7. Regular intake of steroids in the four weeks preceding the date of the admission visit.
  8. Viral or allergic rhinitis, with active effusion.
  9. Down Syndrome
  10. Diagnosis of immotile cilia syndrome
  11. Condition of immune deficiency disease or otherwise.
  12. Cystic Fibrosis.
  13. Dental malocclusion
  14. Other diseases of other organ systems, which, in the opinion of the investigator, may interfere with the purpose or the study procedures.
  15. 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.
  16. Psychic condition incompatible with participation in the research.
  17. History of intolerance or allergy to the components of Sinuclean Nebules.
  18. Medical and surgical intervention that may prejudice the complete execution of the trial, in the 4 weeks preceding the signing of informed consent.
  19. Imminence of a medical-surgical procedure that can jeopardize the completion of the trial.
  20. Participation in the course to other clinical investigations, or terminated within 30 days of the start of this trial.
  21. Previous randomization in the study
  22. Be first- or second-grade relative of a member of the Site study staff.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02858388

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San Gennaro Hospital
Naples, Italy, 80136
Sponsors and Collaborators
Galsor S.r.l.
Catholic University of the Sacred Heart
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Principal Investigator: Attilio Varricchio, MD San Gennaro Hospital, Naples, Italy

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Responsible Party: Galsor S.r.l. Identifier: NCT02858388     History of Changes
Other Study ID Numbers: OME01-2014
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galsor S.r.l.:
Otitis Media with Effusion
Exudative otitis media
Additional relevant MeSH terms:
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Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Pharmaceutical Solutions