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

NCT06478433 | Not Yet Recruiting

• 1 other identifier: Munatoril® Aerosol Combo_2024
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adenoidal Disorder; Tonsillitis; Otorhinolaryngologic Diseases; Nasal Disease

Keywords

nasal irrigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective evaluation for efficacy: Lund-kennedy Score

  T0 (intraopertory ) - T2 (15 days) - T3 (30 days).

Other Outcomes (1)

• Tolerability and recording of any adverse events to assess safety profile

  T1 (8 days - telephone administration) - T2 (15 days) - T3 (30 days).

Study Arms (2)

Munatoril

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Munatoril Aerosol Combo 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.

Munatoril

Iperclenny DEVICE

Hypertonic and Isotonic solution present on market in italy.

Also known as: Isoclenny

Control

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmaluce srl: lead
• Gruppo FarmaImpresa: collaborator

MeSH Terms

Conditions

Tonsillitis; Otorhinolaryngologic Diseases; Nose Diseases

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases

Study Officials

• Laura Tedeschi, Master

  Gruppo FarmaImpresa

  STUDY CHAIR

Central Study Contacts

Nader Nassif, Doctor

CONTACT

0303996226; nader.nassif@asst-spedalicivili.it

Chiara Pastorelli, Master

CONTACT

0303996226; c.pastorelli@erbozeta.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective prospective single-center controlled non-randomized for-profit interventional study.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: June 27, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share