Adelmidrol in Chronic Sinusitis

Summary

The goal of this study is to evaluate whether a nasal spray containing adelmidrol, a mast cell modulator and precursor of palmitoylethanolamide, can reduce inflammation, improve symptoms, and decrease nasal polyp size in patients with chronic rhinosinusitis with nasal polyps. The study will also assess whether adelmidrol can improve surgical outcomes and potentially reduce the need for surgery in selected patients.

The main questions it aims to answer are:

Does adelmidrol nasal spray reduce nasal polyp size and nasal congestion before surgery? Does adelmidrol improve clinical outcomes after Functional Endoscopic Sinus Surgery (FESS)? Can long-term treatment with adelmidrol reduce the need for surgery in patients with less severe nasal polyposis? Researchers will compare patients receiving standard treatment alone with patients receiving standard treatment plus adelmidrol nasal spray. The study is based on evidence suggesting that mast cells contribute to chronic inflammation, eosinophilic infiltration, recurrent infections, and disease persistence in chronic rhinosinusitis with nasal polyps.

Participants will:

Be adults aged 18-70 years diagnosed with chronic rhinosinusitis with nasal polyps and scheduled for FESS.

Be randomly assigned to one of two groups:

Control Group (30 patients): standard therapy consisting of saline nasal irrigation and intranasal corticosteroids before and after surgery.

Treatment Group (30 patients): adelmidrol nasal spray (two sprays per nostril, three times daily) from pre-hospitalization until surgery and for three months after surgery, in addition to standard treatment.

Participants will undergo evaluations at baseline, before surgery after six months of treatment, and three months after surgery. Assessments will include:

MRI or CT imaging; Nasal endoscopy; Sinusitis symptom questionnaires; Nasal Polyp Score (NPS); Nasal Congestion Score (NCS). Researchers will also collect demographic and clinical information, including age, sex, lifestyle habits, comorbidities, and current treatments. Follow-up visits will occur at baseline, before surgery, one month after surgery, and three months after surgery.

The expected outcome is that adelmidrol treatment will significantly reduce nasal polyp burden before surgery and improve postoperative recovery compared with standard therapy alone. Additionally, some patients with mild-to-moderate polyposis may achieve sufficient improvement to avoid surgical intervention altogether

Conditions

• Chronic Sinusitis With Nasal Polyps

Interventions

DRUG

Adelmidrol spray -Rinidrol

Patients in this group will be treated by Adelmidrol spray two puffs for narix two times a day (morning and evening)

DRUG

Nasonex Nasal Spray

1 puff for narix 2 times a day plus nasal washing with saline solution two times a day

COMBINATION_PRODUCT

Nasonex Nasal Spray + Rinidrol

The steroid nasal spray will be combined with Adelmidrol

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Principal Investigators

• Luca D'Ascanio, MD · Aziende Ospedaliere Riunite Marche Nord

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-02

Primary Completion

2025-08-31

Completion

2026-05-30

Countries

• Italy

Study Locations