PER-059-05已完成未知
A DOUBLE-BLIND, RANDOMIZED, MULTI-CENTRAL STUDY OF 3 PERIODS, CROSSED TO EVALUATE THE EFFECTS OF A SINGLE DOSE OF MONTELUKAST COMPARED TO THE PLACEBO AND SALMETEROL IN BRONCHOCONSTRICTION INDUCED BY EXERCISE
MERCK & CO.INC.,0 个研究点目标入组 0 人开始时间: 2005年11月18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
入选标准
- •1. The patient is a man or woman who is between 15 and 45 years old.
- •2. The patient understands the study procedures and is willing to participate in the study.
- •3. The patient is considered to have good and stable health.
- •4. The patient presents evidence of IBD.
- •5. The patient has stable asthma without exacerbations.
- •6. The patient has not smoked for at least 6 months and has a history of having smoked no more than 15 packs per year.
- •7. The patient has a baseline FEV1 before exercise> 70% of what was expected.
- •8. The patient is able to perform reproducible tests of lung function.
排除标准
- •1. The patient is under the age established to give legal consent and the consent of the parent or guardian has not been obtained.
- •2. The patient is, in the opinion of the investigator, mentally or legally incapacitated.
- •3. The patient has donated a unit of blood within the 4 weeks prior to Visit 1.
- •4. The patient has participated in a clinical trial that involves the use of a research drug or marketed within 4 weeks prior to Visit 1.
- •5. The patient is currently a regular user, or has a recent history of abuse of alcohol or illicit drugs.
- •6. The patient is a woman who has <8 weeks post-partum or is breast-feeding a baby.
- •7. The patient is pregnant and / or has a B-hCG test in serum or positive urine.
- •8. The patient is in a situation or has a condition that, in the opinion of the investigator, may interfere with their optimal participation in the study.
- •9. The patient is not able to perform the stress test or the spirometry procedures.
- •10. The patient is hospitalized.
- •11. The patient has undergone a major surgery procedure, has suffered a major trauma that requires medical attention or a significant illness that requires medical attention within 4 weeks prior to Visit 1.
- •12. The patient has a history of anaphylactic allergic reaction related to the administration of a commercialized or investigational drug, or has hypersensitivity to inhaled B-agonists or montelukast.
- •13. The patient has a history of a clinically significant disease.
- •14. The patient has evidence of a disease that may require treatment with an excluded medication.
- •15. The patient presents significant or unexplained abnormalities in the physical examination and / or laboratory tests.
- •16. The patient has a precipitous fall in FEV1 after exposure to exercise.
- •17. The patient requires rescue treatment with immediate-action B-agonists after the physical exertion test and does not return to be within 20% of the baseline FEV1.
- •18. The patient has had an exacerbation of asthma within the previous 4 weeks.
- •19. The patient shows signs and / or unresolved symptoms of an upper respiratory tract infection within 4 weeks of Visit 1.
- •20. The patient has been exposed to cold air sufficiently to produce symptoms of bronchospasm within 2 hours prior to the physical exertion test at Visit 1.
- •21. The patient has exercised or performed strenuous activities within 72 hours prior to Visit 1.
- •22. In addition to asthma, the patient has an active, acute or chronic pulmonary disorder documented with history, physical examination or chest x-ray.
- •23. The patient has hypertension, diabetes mellitus, hypercholesterolemia, hyperlipidemia or a history of these conditions.
- •24. The patient has a systolic blood pressure of> 150 mm Hg or diastolic blood pressure of> 95 mm Hg in> 2 measurements made with> 5 minutes interval in Visit 1.
- •25. The patient presents ECG abnormalities consistent with previous myocardial infarction, hypertrophic cardiomyopathy, ischemic heart disease or conduction system disease.
- •26. The patient has a heart murmur that the investigator considers clinically and / or hemodynamically important.
- •27. The patient presents evidence of ischemic, valvular, hypertrophic, familial heart disease or other forms of heart disease.
- •28. The patient has used oral or parenteral corticosteroids within 12 weeks prior to Visit 1.
- •29. The patient has had a change in the dose of controller th
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