PER-058-05已完成未知
MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CROSS-OVER DESIGN STUDY TO EVALUATE THE EFFECT OF MONTELUKAST AGAINST SALMETEROL IN THE INHIBITION OF INDUCTION OF BRONCHOCONSTRICTION INDUCED BY EXERCISES IN ASTHMATIC PATIENTS OF 6 TO 14 YEARS OF AGE
MERCK & CO.INC.,0 个研究点目标入组 0 人开始时间: 2005年11月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •1) The patient and / or the person in charge of the patient´s care understands the procedures of the study and agrees to participate in it.
- •2) The patient is a child between 6 years of age and at least 14 years of age.
- •3) The patient has been a regular user of inhaled corticosteroids (ICS).
- •4) The patient complies with ALL the signs and symptoms of asthma.
- •5) The patient does not currently consume cigarettes.
- •6) The patient is able to do exercises in a treadmill.
- •7) The patient is considered to have good and stable mental and physical health.
- •8) A forced expiratory volume in one second (FEVi)> 70% of the predicted value, while the B-agonist is suspended for at least 6 hours.
排除标准
- •1. Consent may not be obtained from the parent or guardian.
- •2. The patient is legally incompetent or mentally disabled.
- •3. The patient is hospitalized.
- •4. The patient has undergone major surgery within 4 weeks of Visit 1.
- •5. The patient has participated in a clinical trial that involves the use of an investigational drug or a commercial drug within 4 weeks of Visit 1.
- •6. The patient suffers from an active, acute or
- •7. The patient has unresolved signs and symptoms of upper respiratory tract infection (URI) within 1 week of Visit 1.
- •8. The patient shows evidence of a clinically significant active nasal sinus infection.
- •9. The patient has ever been intubated for asthma, has required therapy for acute asthma, which was treated in an emergency room / urgent care center / office within the month prior to Visit 1, or has been hospitalized for asthma within three months prior to Visit 1.
- •10. The patient has a recent history of a clinically significant psychiatric disorder.
- •11. The patient has a history of an anaphylactic allergic reaction related to the administration of either an investigational or commercial drug, or, otherwise, is hypersensitive to salbuterol, salmeterol, fluticasone or montelukast.
- •12. The patient suffers from an active, clinically significant disease.
- •13. The patient has a history of any disease that would require treatment with an excluded medication.
- •14. The patient has taken any of the prohibited drugs within the designated time before Visit 1.
- •15. The patient has initiated immunotherapy within six months prior to Visit 1.
- •16. The patient has significant or unexplained abnormalities in laboratory measurements.
- •17. The potentially fertile patient demonstrates a level of B-hCG indicating a state of gravidity.
- •18. The patient has unresolved signs and symptoms of upper respiratory tract infection (URI) during the transition period.
- •19. The patient is unable or unwilling to comply with the study procedures.
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