A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endoscopy Polyp Grading
研究概览
简要总结
This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •18-75 years of age
- •bilateral nasal polyposis Grade 2 and above
- •with or without asthma
- •with or without atopy or aspirin sensitivity
- •written informed consent
排除标准
- •unilateral nasal polyposis
- •polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
- •known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
- •Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- •significant (≥50%)septal deviation
- •inability to comply with the requirements of the protocol
- •females who are pregnant, lactating or planning to become pregnant.
研究组 & 干预措施
Placebo
Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months
干预措施: Placebo (Drug)
Placebo
Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months
干预措施: fluticasone nasal drops (Other)
Placebo
Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months
干预措施: fluticasone nasal spray (Other)
Prednisolone
25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months
干预措施: Prednisolone (Drug)
Prednisolone
25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months
干预措施: fluticasone nasal drops (Other)
Prednisolone
25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months
干预措施: fluticasone nasal spray (Other)
结局指标
主要结局
Endoscopy Polyp Grading
时间窗: 0, 2 weeks, 10 weeks, 28 weeks
次要结局
- Mini RQLQ(0, 2 wks, 10 wks, 28 wks)
- TNS-4(0, 2 wks, 10 wks, 28 wks)
- PNIF(0,2 wks, 10 wks,28 wks)
- Anosmia score(0, 2 wks, 10 wks, 28 wks)
- Scratch n Sniff cards(0, 2 wks, 10 wks, 28 wks)
- OUCC(0, 2 wks, 10 wks, 28 wks)
- 1 mcg Synacthen test(0, 2 wks, 10 wks, 28 wks)