NCT00755794
已完成
3 期
An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma
概览
- 阶段
- 3 期
- 干预措施
- montelukast sodium
- 疾病 / 适应症
- Asthma
- 发起方
- Organon and Co
- 入组人数
- 800
- 主要终点
- To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.
研究者
入排标准
入选标准
- •Patients Is 18 Years Old
- •Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit
- •Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained
排除标准
- •Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
研究组 & 干预措施
1
Montelukast
干预措施: montelukast sodium
结局指标
主要结局
To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids
时间窗: 8 weeks
次要结局
- To evaluate the safety and tolerability of montelukast(8 weeks)
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