A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Time to relapse in polyp score after surgery
研究概览
简要总结
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Bilateral nasal polyps
- •Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)
排除标准
- •Polypectomy within the last 6 months
- •Unhealed nasal surgery/trauma
- •>5 previous polypectomies
- •Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
- •Nasal infection
- •Pulmonary tuberculosis
- •Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
- •Immunocompromised
- •Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
- •Known hereditary mucociliary dysfunction
- •Significant nasal structure abnormalities
- •Asthmatic attack within the past 30 days
- •Asthmatic patients requiring >1000 mcg beclomethasone or equivalent
- •Asthmatic patients not stable on corticosteroid therapy
研究组 & 干预措施
Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
干预措施: Mometasone Furoate Nasal Spray (Drug)
Placebo
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
干预措施: Placebo (Drug)
结局指标
主要结局
Time to relapse in polyp score after surgery
时间窗: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
次要结局
- Quality of life, peak nasal inspiratory flow, olfaction threshold(Measured starting 1 week after treatment up to 24 weeks of treatment)
- Signs and symptom scores(All study visits (up to 24 weeks of treatment))
- Adverse events(Throughout the whole study after the Screening period.)