Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Persistent Rhinitis Moderate to Severe
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
研究概览
简要总结
This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.
详细描述
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.
This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of allergic persistent rhinitis moderate to severe at least 2 years
- •Proved allergic using PRICK or RAST test
- •Nasal symptoms (NIS) > 3 and nasal obstruction >1
- •Indication of nasal corticosteroids use
- •Washout of nasal corticosteroids for 14 days
排除标准
- •Other types of rhinitis
- •Asthma non controlled
- •Use of oral/injectable corticoids 30 days before screening
- •patients not eligible to complete diaries
- •patients with allergy to any substance of medicines
- •non controlled disease
研究组 & 干预措施
Budesonid 50mcg (Noex)
Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
干预措施: Budesonid 50mcg (Noex) (Drug)
Budesonid 50mcg (Busonid)
Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
干预措施: Budesonid 50mcg (Busonid) (Drug)
结局指标
主要结局
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
时间窗: 28 days
Using the questionnaire Nasal Index Score (NIS)
次要结局
未报告次要终点