Clinical trial NCT06478433: Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.
Official title: "Efficacy and Safety Study of the Medical Device Munatoril® Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy."
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adenoidal Disorder
Tonsillitis
Otorhinolaryngologic Diseases
Nasal Disease
Keywords: nasal irrigation
Lead sponsor: Pharmaluce srl
Sponsor class: INDUSTRY
Collaborators: name: Gruppo FarmaImpresa
First posted: 2024-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective prospective single-center controlled non-randomized for-profit interventional study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Subjective evaluation for efficacy: QoL
timeFrame: T0 (preoperative) - T2 (15 days) - T3 (30 days).
Secondary outcomes:
measure: Objective evaluation for efficacy: Lund-kennedy Score
timeFrame: T0 (intraopertory ) - T2 (15 days) - T3 (30 days).
Other outcomes:
measure: Tolerability and recording of any adverse events to assess safety profile
timeFrame: T1 (8 days - telephone administration) - T2 (15 days) - T3 (30 days).
Locations:
Study officials:
affiliation: Gruppo FarmaImpresa
name: Laura Tedeschi, Master
role: STUDY_CHAIR
References: