Effect of Adelmidrol Nasal Spray on Chronic Rhinosinusitis With Nasal Polyps: A Randomized Controlled Study Evaluating Clinical, Endoscopic, and Radiological Outcomes Before and After Functional Endoscopic Sinus Surgery (FESS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adelmidrol and Nasal Polyps score
研究概览
简要总结
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
详细描述
Objectives Primary Objective To determine whether long-term treatment with adelmidrol nasal spray reduces nasal polyp size in patients with CRSwNP compared with standard treatment alone.
Secondary Objectives To evaluate changes in sinonasal symptoms. To assess changes in nasal congestion. To evaluate radiological improvement. To determine postoperative outcomes after FESS. To assess whether adelmidrol treatment may reduce the need for surgery in patients with limited disease.
To evaluate treatment safety and tolerability. Study Design Prospective Randomized Controlled Parallel-group study Single-center (or multicenter if applicable) Study Duration
Approximately 9 months per patient:
Baseline (T0) 6 months preoperative treatment (T1) Surgery (FESS) Follow-up at 1 month (T2) Follow-up at 3 months (T3) Sample Size Calculation The primary endpoint is the change in Nasal Polyp Score (NPS). Based on previous CRSwNP studies, a clinically meaningful difference between groups is expected to be approximately 1.0 point in total NPS, with an estimated standard deviation of 1.4 points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adelmidrol and Nasal Polyps score
时间窗: 3 months
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.
次要结局
- Number of participants who do not need FESS(6 months)
研究者
Arianna Di Stadio
Associate Professor of Otolaryngology
University of Campania Luigi Vanvitelli