CompletedNot Applicable

Adelmidrol in Chronic Sinusitis

Italy60 participantsStarted 2025-01-02

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for enrollment: * Male or female patients aged 18 to 70 years. * Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) requiring surgical treatment. * Presence of nasal polyps confirmed by clinical examination and nasal endoscopy. * Candidates for Functional Endoscopic Sinus Surgery (FESS) for removal of one or more nasal polyps. * Ability and willingness to comply with study procedures, treatment regimen, follow-up visits, and assessments. * Ability to provide written informed consent. * No treatment with antihistamines during the previous 6 months. * No ongoing treatment with topical or systemic corticosteroids at the time of enrollment. Exclusion Criteria: * Chronic maxillary sinusitis without nasal polyps. * Previous endoscopic sinonasal surgery within the preceding 12 months. * Current treatment with systemic antihistamines. * Current treatment with topical or systemic corticosteroids. * Diagnosis of asthma. * History of radiotherapy to the head and neck region within the previous 3 years. * Current or recent (within the previous 3 years) treatment for any form of cancer. * Presence of a serious neurological disorder that could interfere with study participation or outcome assessment. * Known immunodeficiency, including but not limited to Acquired Immunodeficiency Syndrome (AIDS). * Acute purulent sinusitis associated with fever requiring antibiotic therapy. * Requiremen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adelmidrol and Nasal Polyps score

Timeframe: 3 months

Trial details

NCT IDNCT07675512

SponsorUniversity of Campania Luigi Vanvitelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Chronic Sinusitis With Nasal Polyps trials