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

NCT ID: NCT06478433

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-06-01

Brief Summary

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.

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.

Conditions

Adenoidal Disorder; Tonsillitis; Otorhinolaryngologic Diseases; Nasal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Munatoril Aerosol Combo

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Iperclenny

Intervention Type: DEVICE

Hypertonic and Isotonic solution present on market in italy.

Interventions

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.

Intervention Type: DEVICE

Iperclenny

Hypertonic and Isotonic solution present on market in italy.

Intervention Type: DEVICE

Other Intervention Names

Isoclenny

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo FarmaImpresa

INDUSTRY

Sponsor Role: collaborator

Pharmaluce srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Tedeschi, Master

Role: STUDY_CHAIR

Gruppo FarmaImpresa

Central Contacts

Nader Nassif, Doctor

Role: CONTACT

nader.nassif@asst-spedalicivili.it

0303996226

Chiara Pastorelli, Master

Role: CONTACT

c.pastorelli@erbozeta.com

0303996226

Other Identifiers

Munatoril® Aerosol Combo_2024

Identifier Type: -

Identifier Source: org_study_id