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Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

Primary Purpose

Otitis Media With Effusion

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Sinuclean Nebules 45

Saline solution

About this trial

This is an interventional treatment trial for Otitis Media With Effusion focused on measuring Otitis Media with Effusion, Exudative otitis media

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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:

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.
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.

Sites / Locations

San Gennaro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SN45

Sal

Arm Description

Sinuclean Nebules 45

Saline solution

Outcomes

Primary Outcome Measures

Resolution of tympanic effusion

The resolution of the tympanic effusion will be assessed with tympanogram (% of subjects with type A tympanogram).

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02858388

First Posted

June 26, 2016

Last Updated

August 3, 2016

Sponsor

Galsor S.r.l.

Collaborators

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT02858388

Brief Title

Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

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 Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galsor S.r.l.

Collaborators

Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media With Effusion

Keywords

Otitis Media with Effusion, Exudative otitis media

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SN45

Arm Type

Active Comparator

Arm Description

Sinuclean Nebules 45

Arm Title

Sal

Arm Type

Placebo Comparator

Arm Description

Saline solution

Intervention Type

Device

Intervention Name(s)

Sinuclean Nebules 45

Intervention Description

Nebulization of solution

Intervention Type

Other

Intervention Name(s)

Saline solution

Intervention Description

Nebulization of solution

Primary Outcome Measure Information:

Title

Resolution of tympanic effusion

Description

The resolution of the tympanic effusion will be assessed with tympanogram (% of subjects with type A tympanogram).

Time Frame

At Day 28 after start of treatment

Secondary Outcome Measure Information:

Title

Complete auditory recovery

Description

The auditory recovery will be measured with tonal audiometry, % of subjects recovering normal values (threshold by air between 0 and 25 dB).

Time Frame

At Day 28 after start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Attilio Varricchio, MD

Organizational Affiliation

San Gennaro Hospital, Naples, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Gennaro Hospital

City

Naples

ZIP/Postal Code

80136

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

2083987

Citation

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.

Results Reference

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Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

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