Adelmidrol in Chronic Sinusitis

NCT07675512 | Completed

• 1 other identifier: AORMN2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic sinusitis; Mastocites; Allergy; FESS; Nasal spray

Outcome Measures

Primary Outcomes (1)

• Adelmidrol and Nasal Polyps score

  The use of Ademidrol will reduce nasal polyp score (NPS) before surgery (T1) and improve the outcomes after FESS (T2) with statistically significant difference were compared with control. NPS score goes from 0 (normal ) to 4 (complete nasal occlusion)and the score is evaluated singularly from each side of the nose. Total scores range from 0 to 8.

  3 months

Secondary Outcomes (1)

• Number of participants who do not need FESS

  6 months

Study Arms (3)

Standard treatment

ACTIVE COMPARATOR

The patients in the control group will be treated by Nasonex (mometasone fluoridate) ( 1 puff for nary two time a day )and nasal irrigation two times a day (morning ad evening)

Drug: Nasonex Nasal Spray

Adelmidrol spray

EXPERIMENTAL

Adelmidrol nasal spray (Rinidrol) 2 puff for narix two times a day (morning and evening)

Drug: Adelmidrol spray -Rinidrol

Combination of Cortisone Nasal Spray and Adelmidrol

EXPERIMENTAL

Patients in this group will be treated by Nasonex (mometasone fluoridate) exactly as control (1 puff for narix two times a day) plus Adelmidrol (Rinidrol) (2 puff for narix two times a day)

Combination Product: Nasonex Nasal Spray + Rinidrol

Interventions

Adelmidrol spray -Rinidrol DRUG

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

Adelmidrol spray

Nasonex Nasal Spray DRUG

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

Standard treatment

Nasonex Nasal Spray + Rinidrol COMBINATION_PRODUCT

The steroid nasal spray will be combined with Adelmidrol

Combination of Cortisone Nasal Spray and Adelmidrol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Requirement for systemic antibiotic treatment at enrollment.
• Current treatment with oral anticoagulants (e.g., warfarin).
• Any medical condition that, in the investigator's judgment, may compromise patient safety, adherence to the protocol, or interpretation of study results.
• Development of fever or a bacterial infection requiring antibiotic therapy during the follow-up period; such patients will be withdrawn from the study after enrollment according to the protocol.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Ospedale di Fano, Dipartimento di Otorinolaringoiatria

Fano, Italy

Location

Related Publications (6)

• Della Volpe A, Bruno C, De Luca P, Ralli M, Di Stadio A. Adelmidrol to fight upper airways inflammation in children: a pilot case control study to safety and efficacy. Eur Arch Otorhinolaryngol. 2025 Jun;282(6):3075-3083. doi: 10.1007/s00405-025-09375-z. Epub 2025 Apr 21.

  PMID: 40258991 RESULT

• Pawankar R. Mast cells in allergic airway disease and chronic rhinosinusitis. Chem Immunol Allergy. 2005;87:111-129. doi: 10.1159/000087639.

  PMID: 16107767 RESULT

• Corredera E, Phong BL, Moore JA, Kane LP, Lee SE. TIM-3-Expressing Mast Cells Are Present in Chronic Rhinosinusitis with Nasal Polyps. Otolaryngol Head Neck Surg. 2018 Sep;159(3):581-586. doi: 10.1177/0194599818774560. Epub 2018 May 15.

  PMID: 29759032 RESULT

• Philpott CM, Erskine S, Hopkins C, Kumar N, Anari S, Kara N, Sunkaraneni S, Ray J, Clark A, Wilson A; CRES group; Erskine S, Philpott C, Clark A, Hopkins C, Robertson A, Ahmed S, Kara N, Carrie S, Sunkaraneni V, Ray J, Anari S, Jervis P, Panesaar J, Farboud A, Kumar N, Cathcart R, Almeyda R, Khalil H, Prinsley P, Mansell N, Salam M, Hobson J, Woods J, Coombes E. Prevalence of asthma, aspirin sensitivity and allergy in chronic rhinosinusitis: data from the UK National Chronic Rhinosinusitis Epidemiology Study. Respir Res. 2018 Jun 27;19(1):129. doi: 10.1186/s12931-018-0823-y.

  PMID: 29945606 RESULT

• Pipolo C, Saibene AM, Felisati G. Prevalence of pain due to rhinosinusitis: a review. Neurol Sci. 2018 Jun;39(Suppl 1):21-24. doi: 10.1007/s10072-018-3336-z.

  PMID: 29904833 RESULT

• Klimek L, Koennecke M, Hagemann J, Wollenberg B, Becker S. [Immunology of chronic rhinosinusitis with nasal polyps as a basis for treatment with biologicals]. HNO. 2019 Jan;67(1):15-26. doi: 10.1007/s00106-018-0557-7. German.

  PMID: 30167718 RESULT

MeSH Terms

Conditions

Hypersensitivity

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luca D'Ascanio, MD

  Aziende Ospedaliere Riunite Marche Nord

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology

Model Details: Case-control study

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 30, 2026
• Study Start: January 2, 2025
• Primary Completion: August 31, 2025
• Study Completion: May 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

IT (1)