EUCTR2005-003991-39-DE进行中（未招募）不适用
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL CROSSOVER TRIAL IN ADULT ASTHMATICS EVALUATING THE EFFECT OF CONCOMITANT TWO WEEKS TREATMENT WITH MONTELUKAST (SINGULAIR™) 10 MG ONCE DAILY OR MATCHING PLACEBO TO PREVENT THE DEVELOPMENT OF TOLERANCE TO BRONCHOPROTECTION AND BRONCHODILATION BY BETA-AGONISTS OCCURRING AFTER TWO WEEKS REGULAR TREATMENT WITH SALMETEROL (SEREVENT™) 50µG B.I.D. - PREDATOR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •intermittent or mild persistent asthmatics (GINA step 1 and 2, GINA 2004)
- •positive skin test to more or equal to 1 allergen within the last 12 months prior to screening or at screening visit
- •PC20 methacholine below or equal to 4 mg/ml at screening
- •FEV1 >85% pred
- •Asthma medication: only short-acting beta-agonists prn
- •written informed consent
- •patients who, with the exception of asthma, are in good health
- •clinical stable asthma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •asthma severity > step 2 GINA
- •history of lower or upper airway infection in the last 4 weeks prior to screening
- •diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung dis-eases (e. g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis)
- •current smoker and ex-smokers with more than 10 pack years*
- •(* 1 pack year is defined as 20 cigarettes/day for 1 year.)
- •clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (assessed by the investigator)
- •suspected hypersensitivity and / or contraindication to any ingredients of the study medication and / or the rescue medication
- •use of prohibited medication prior to screening and throughout the study
- •wash-out times of drugs defined in protocol cannot be adhered to
- •alcohol and / or drug abuse
- •pregnancy, breast feeding
- •women of childbearing potential need to practice a safe contraception during the entire course of the study
- •participation in another clinical trial within 30 days preceding the screening visit
- •patients not able to follow study procedures (e.g. language problems, psychological disorders)
- •suspected non-compliance
- •known hypersensitivity to Montelukast, SereventTM Diskus, or Salbutamol MDI or any of the ingredients
研究者
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