CTRI/2011/06/001788尚未招募3 期
A Randomized, Open Label, Comparative, Parallel Group, Efficacy and Safety study of Budesonide Dry Powder Inhaler Rotacaps 400 mcg in Patients with Mild to Moderate Asthma - ASIA
Inventia Healthcare Private Limited0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •i)Patients of either sex between 18 to 65 years with a diagnosis of mild to moderate persistent asthma (minimum duration, 6 months)
- •Type of Asthma% FEV1 (Forced Expiratory Volume in One Second)
- •Mild Asthma¡Ý 80%
- •Moderate Asthma60-80%
- •ii)Patient who inhaled corticosteroids at a constant dose (200 to 500 mcg/day) for at least 1 month prior to inclusion in the study will be enrolled.
排除标准
- •i) Use of oral, parenteral, or rectal corticosteroids within 30 days of study commencement.
- •ii)Respiratory infection affecting disease control within the previous 4 weeks.
- •iii)Known hypersensitivity to Budesonide.
- •iv)Patients with severe cardiovascular disorders or other pulmonary diseases.
- •v)Current and Ex-smokers with a history of smoking for ¡Ý 10 pack-years.
- •vi)Pregnant or lactating females or women of childbearing potential without any efficient contraception.
- •vii)Seasonal asthma or asthma occurring only during episodic exposure to an allergen.
研究者
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