JPRN-UMIN000003724招募中未知
Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS - Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS (EVOLUTION study)
IAA Study Group0 个研究点目标入组 280 人开始时间: 2010年6月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 280
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •[At start of observation period] 1) Patients with frequent nocturnal symptoms 2) Patients with limited daily activities 3) Patients who are judged to require oral steroid therapy to control asthmatic symptoms at start of observation period 4) Patients with %FEV1.0 less than 60% at start of period 5) Patients who have used steroid therapy (injection, oral preparation, intestinal infusion, or suppository) within 4 weeks before start of period 6) Patients who have started treatment with any leukotriene receptor antagonist within 2 months before start of period 7) Patients who have any coexisting respiratory infection including tuberculosis or acute upper respiratory tract inflammation/bronchitis, or those who have a history of such infections within 4 weeks before start of period 8) Patients who have any coexisting respiratory disease (COPD, pulmonary fibrosis, etc.) other than asthma 9) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication 10) Patients who have coexisting malignant tumor or a history of malignant tumor 11) Patients who have started new hyposensitization or nonspecific therapy within 3 months before start of period 12) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study 13) Others deemed unsuitable by the investigator 14) Patients who meet any of the contraindications described in the package insert of the study drug [At start of observation period] 1) Subjects with a body temperature of 37.5 degrees or above that suggests acute upper respiratory tract inflammation/bronchitis during observation period 2) Subjects who have used new asthma therapy other than the pretreatment drug during observation period 3) Subjects who have used steroid therapy (injection, oral preparation, inhalation, intestinal infusion, or suppository) during observation period 4) Others deemed unsuitable by the investigator
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