PER-008-06已完成未知
A MULTICENTER AND RANDOMIZED, DOUBLE-BLIND STUDY OF PARALLEL GROUPS, OF 6 MONTHS OF DURATION TO EVALUATE THE EFFICACY AND SAFETY OF ORAL SODIUM MONTELUKAST, FLUTICASONE PROPIONATE AND PLACEBO IN SMOKING PATIENTS WITH CHRONIC ASTHMA
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年4月12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 understands the study procedures and agrees to participate by signing the corresponding informed consent form.
- •2. The patient is a man or woman> 18 to <55 years of age
- •3. Female patients must have a level of B-hCG in urine
- •consistent with non-pregnant status in Visit 1. Patients agree to use appropriate contraceptives at least 30 days before their first study visit and continue using them for at least 14 days after Visit 5 or discontinuation visit.
- •4. The patient presents all the signs and symptoms consistent with the diagnosis of asthma in Visit 1.
- •5. Smokers with a smoking history of 30 packs-year or less.
- •6. The patient agrees not to change their usual consumption of caffeinated beverages during the entire study.
- •7. It is considered that the patient is in good health and stable in the physical and mental.
排除标准
- •1. The patient is mentally or legally disabled, which prevents obtaining informed consent.
- •2. The patient is hospitalized.
- •3. The patient is a woman who is pregnant or has <8 weeks postpartum or is breastfeeding.
- •4. The patient intends to move or go on vacation for a period of time that would prevent their participation in the study.
- •5. The patient has undergone a major surgery procedure within four weeks of Visit 1.
- •6. The patient has participated in a clinical trial that involves the use of a research drug or marketed within four weeks of Visit 1.
- •7. The patient is currently a habitual user of drugs or alcohol or has a recent history, within the last 5 years, of illicit drug abuse or recent alcohol abuse.
- •8. The patient has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- •9. The patient has ever been intubated due to asthma, has required acute therapy for asthma administered in an emergency room / urgent care facility / office within one month or has been hospitalized for asthma within three months of the Visit 1.
- •10. The patient suffers, in addition to asthma, some active, acute or chronic lung disorder documented by history, physical examination or a chest x-ray.
- •11. The patient presents with symptoms and unresolved signs of an upper respiratory tract infection (URI) within 3 weeks of Visit 1.
- •12. The patient presents evidence of an active sinus infection and clinically significant.
- •13. The patient has a recent history of a clinically significant psychiatric disorder.
- •14. The patient has a history of anaphylactic allergic reaction related to the administration of either a commercially available or investigational drug or otherwise has hypersensitivity to montelukast sodium, fluticasone propionate or salbutamol or any of these components drugs.
- •15. The patient suffers from an active gastrointestinal disease, cardiovascular, hepatic, neurological, renal, genitourinary or hematologic clinically significant.
- •16. The patient has uncontrolled hypertension.
- •17. The patient has a history of a disease that will require treatment with an excluded medication.
- •18. Patients known to be HIV positive.
- •19. Cancer within the last 5 years.
- •20. The patient has received some of the prohibited drugs before Visit 1.
- •22. The patient has initiated immunotherapy within 6 months prior to the Pre-selection visit and / or it is expected that the dose of the same will change during the course of the study.
- •23. The patient is not able to perform acceptable and reproducible spirometry or FEFR measurements
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