NCT00344942终止3 期
A Randomised, Double-blind, French Multi-centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness.
研究概览
简要总结
To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient presenting with Chronic Non Allergic and Non Infectious Rhinitis capable of benefiting from corticosteroid therapy administered via the nasal route.
- •patient with chronic rhinitis of minimum duration 12 weeks, whether or not consecutive, per year.
- •patient with Non Allergic Rhinitis confirmed by negative phadiatop test.
- •patient presenting a mean global score for the 5 symptoms >= 5 (nasal obstruction, rhinorrhea, disturbance of sense of smell, sneezing, facial heaviness), or mean score for the 3 main symptoms (nasal obstruction, rhinorrhea, disturbance of sense of smell) >= 5 (mean for 7 days prior to visit V0).
- •patient presenting an inflammation score at anterior rhinoscopy or nasal endoscopy >= 4.
排除标准
- •patient presenting a nasal polyp
- •patient presenting a severe septal deviation which would interfere with insertion of the nasal spray
- •patient presenting a nasal cavity tumor
- •patient presenting a sinus infection
- •patient presenting a history of endonasal surgery
- •patient presenting a chronic rhinitis of extrinsic origin (drug-related or food-related rhinitis) or intrinsic origin (hormonal rhinitis, positional rhinitis,atrophic rhinitis, ...)
- •patient on a program of intensive sports training
- •patient presenting with : cystic fibrosis, pulmonary mycosis, necrotising vascularitis, immotile cilia syndrome, ....
- •patient presenting with known immunosuppression, lymphoma
- •patient presenting with a known cardiovascular, neurological or other medically significant illness
- •patient presenting with known renal failure, with known glaucoma, with known drug addiction
- •current antibiotic therapy
- •corticosteroids administered in the two months prior to admission
- •patient presenting problems of haemostasis (epistaxis), ophthalmic and/or oro-bucco-nasal herpetic infection.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: triamcinolone acetonide (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness.
时间窗: 7 days prior to each visit
次要结局
- list of undesirable events(during the treatment period)
研究者
研究点 (1)
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