Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.

"Efficacy and Safety Study of the Medical Device Munatoril® Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy."

The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy, compared with a hypertonic solution and an over-the-counter isotonic solution (control group).

The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution.

Endpoints Evaluation of subjective longitudinal differences (intragroup over-time change) and differences between study group and control group (intergroup difference) regarding the use of the medical device, obtained following the protocol, with assessment at 8, 15 and 30 days after surgery by Likert Scale Score for tolerability, and at 0, 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy.

In addition, there is a recording of any adverse events in both groups at 8, 15 and 30 days post-surgery, and an inter-group comparative evaluation.

Participants: Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited. Follow-up will last 30 days.

Study Overview

• Status: Not yet recruiting
• Conditions: Otorhinolaryngologic Diseases; Tonsillitis; Nasal Disease; Adenoidal Disorder
• Intervention / Treatment: Device: Munatoril Aerosol Combo; Device: Iperclenny

Detailed Description

Sample selection criteria

Inclusion criteria.

Patients of either sex aged 2 to 17 years, candidates for adenoidectomy or adenotonsillectomy surgery.

Acquisition and signing of informed consent by the legal guardian. Exclusion criteria.

Syndromic patients. Patients allergic to any substance in the study formulations. Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.

Active respiratory infection in the 2 weeks prior to study entry. Patients with a history of chronic epistaxis or immunodeficiency. 2.3 Study exit criteria.

For reasons related to study treatment (adverse event); for reasons related to surgery (adverse event); for non-treatment-related reasons (death due to illness, patient transfer to other treatment site); for patient-related reasons (withdrawal of consent, poor compliance); for reasons related to compliance with procedures/other (protocol violations, administrative problems); for withdrawal of consent by the patient's parents or legal guardians. In cases of exit from follow-up, there is provision for reporting the exit, including the date and reasons for it.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nader Nassif, Doctor; Phone Number: 0303996226; Email: nader.nassif@asst-spedalicivili.it
• Study Contact Backup: Name: Chiara Pastorelli, Master; Phone Number: 0303996226; Email: c.pastorelli@erbozeta.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.
• Acquisition and signing of informed consent by the legal guardian.

Exclusion Criteria:

• Syndromic patients.
• Patients allergic to any substance in the study formulations.
• Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
• Active respiratory infection in the 2 weeks prior to study entry.
• Patients with a history of chronic epistaxis or immunodeficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Munatoril; Experimental: Munatoril From day 1 to day 7 postoperatively: SID administration of Munatoril® Aerosol Combo by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe. From day 8 to day 14 postoperatively: SID administration of Munatoril® Aerosol Combo via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe. - From postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution obtained by diluting Munatoril® Aerosol Combo hypertonic solution	Device: Munatoril Aerosol Combo; Munatoril® Aerosol Combo is a Medical Device that contains: 5 ml single-dose vials of sterile, 3% hypertonic, near-neutral pH bromine-iodine saline solution, based on Cervia integral sea salt, salso-bromo-iodine saline mother water from the Cervia Thermal Baths and hyaluronic acid with high molecular weight. Lavonase® syringe with blue nebulizer valve (microsol), 10 ml, Medical Device for the administration of solutions in nebulized form within the nasal cavities and nasopharynx.
Active Comparator: Control; Active Comparator: Control Day 1 to day 7 postoperative: SID administration of Hypertonic Solution by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe. Postoperative day 8 to day 14: SID administration of hypertonic solution via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe. - Postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution.	Device: Iperclenny; Hypertonic and Isotonic solution present on market in italy.; Other Names: Isoclenny

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation for efficacy: QoL	The investigator will use the questionnaire "Sino-Nasal Outcome Test-22 (SNOT-22)" for the evaluation of QoL and the symptoms impact on patient's life. The SNOT-22 is based on a Likert scale where 0 = "No problem", 1 = "Very mild problem", 2 = "Mild or slight problem", 3 = "Moderate problem", 4 = "Severe problem", and 5 = "Problem as bad as it can be." Are 22 items and the score can be from 0 to 110. Higher scores means a worse outcome.	T0 (preoperative) - T2 (15 days) - T3 (30 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective evaluation for efficacy: Lund-kennedy Score	Lund-kennedy Score: This score assesses the severity of three objective data trough nasal endoscopy. It is polyps (0, none; 1, in the middle meatus; 2, beyond the middle meatus); discharge (0, none; 1, clear and thin; 2, thick and purulent); edema (0, absent; 1, mild; 2, severe); scarring/adhesions (0, absent; 1, mild; 2, severe); and crusting (0, absent; 1, mild; 2, severe). The score can be from 0 to 10. Higher scores means a worse outcome.	T0 (intraopertory ) - T2 (15 days) - T3 (30 days).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability and recording of any adverse events to assess safety profile	Likert Scale Score from 1 to 5 score. Higher scores means a worse outcome.	T1 (8 days - telephone administration) - T2 (15 days) - T3 (30 days).

Collaborators and Investigators

• Sponsor: Pharmaluce srl
• Collaborators: Gruppo FarmaImpresa
• Investigators: Study Chair: Laura Tedeschi, Master, Gruppo FarmaImpresa

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: nasal irrigation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Pharyngitis; Tonsillitis; Otorhinolaryngologic Diseases; Nose Diseases
• Other Study ID Numbers: Munatoril® Aerosol Combo_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No