MK-476 Phase III Open Label Exploratory Comparative Study -Acute Exacerbations of Asthma-Protocol number: 334 - MK-476 Phase III Open Label Exploratory Comparative Study -Acute Exacerbations of Asthma

Banyu Pharmaceutical Co., Ltd.0 个研究点目标入组 91 人开始时间: 2015年4月3日最近更新: 2015年4月13日

适应症

试验速览

暂无简介。

•Age: between 15 and 75 years of age.
•Gender: irrelevant
•All females must demonstrate a urine ?-hCG level consistent with the nongravid state (it’s not necessary if 3 years have passed since the onset of menopause, and if pregnancy is organically impossible).Patient has at least a 1 year history of asthma.
•Patient understands the study procedures and agrees to participate as indicated by signing the appropriate informed consent.
•All females must demonstrate a urine ?-hCG level consistent with the nongravid state prior to random allocation. Patient is admitted to the study site because of an acute exacerbation of asthma. Patient has a forced expiratory volume in 1 second (FEV1) of < 70% of the predicted value at each evaluation. Patient is able to perform reproducible pulmonary tests (spirometry) as described Protocol. Patient agrees to administration of study drug as indicated by signing the confirmation slip.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 31

•Patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
•The patient’s asthma has lifethreatening features, including, but not limited to, immediate respiratory failure, the need for intubation, evidence of a pneumothorax or pneumomediastinum.
•The patient is febrile (temperature >38.0°C) OR has signs or symptoms of pneumonia in Screening period.
•The time in Screening period (between initiation of first ?-agonist nebulization after study site admission and study drug administration) exceeds 60 minutes..
•The percent predicted FEV1 value has increased or decreased by 20 percentage points between 2 measurements during Screening period.
•Patient has FEV1 of <30% of the predicted value or Spo2 <90% during Screening period.
•Patient has any comorbid disorder that would require therapy during Screening period and Treatment period.
•Patient has received any dose of corticosteroids (other than their usual dose and other than percutaneous, eye drop, and nasal drops) within 6 hours of starting Screening period.

发起方