CTRI/2017/02/007787尚未招募3 期
Open-label, Multicentre, Randomized, Comparative Study of the efficacy and Safety of Budesonide, Inhalation powder, Capsule 400 μg/dose (Sava Healthcare Limited, India), and Pulmicort® Turbuhaler®, Inhalation powder, pre-dispensed, 200 μg/dose (AstraZeneca AB, Sweden), in Patients with Partially Controlled Asthma.â?? - DPI
Rus Biopharm LLC0 个研究点目标入组 136 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
- 136
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
- •Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit
- •Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy
- •ACQ-5 score >= 0.75 and < 1.5.
- •Forced expiratory volume in 1 second (FEV1) prior to administration of bronchodilators not less than 60 % of the due value.
- •Availability of a signed and dated Informed Consent Form for participation in the study.
排除标准
- •Contraindications for treatment with inhaled IC, hypersensitivity to budesonide, salbutamol, or to any other ingredient included in the formulation of salbutamol.
- •Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
- •Body mass index (BMI) > 35 kg/m2.
研究者
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