Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic 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 comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
研究概览
简要总结
This study is to evaluate non inferiority of Eurofarma budesonide nasal spary 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 persisntent rhinits moderate to severe in sites localted locally in Brasil.
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 alergic persistent rhinitis moderate to severe at least 2 years.
- •Proved alergic using PRICK or RAST test.
- •Nasal symptoms (NIS) > 3 and nasal obstruction >
- •Indication of nasal corticorteroids use..
- •Washout of nasal corticorteroids for 14 days.
排除标准
- •Other types of rhinitis;
- •Asthma non controled
- •Use of oral/injectable corticoids 30 days before screening.
- •patients not eligible to complete diaries.
- •patients with alergy to any substance of medicines.
- •non controlled desease.
研究组 & 干预措施
Noex 32mcg
Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days.
干预措施: Budesonide (Drug)
Budecort Aqua 32 mcg
Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days.
干预措施: Budesonide (Drug)
结局指标
主要结局
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
时间窗: 28 days
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
次要结局
未报告次要终点