EUCTR2012-000643-27-DE进行中（未招募）不适用
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma - Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma
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
- 1,480
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
- •Subject is a female or male subject between 18 and 75 years of age
- •Subject has a consistent clinical history, for at least one year, of symptoms of persistent asthma that may include, but are not limited to, dyspnea, wheezing, chest tightness, cough, and/or sputum production
- •While withholding SABAs for at least 6 hours and long-acting ß-agonists (LABAs) for at least 12 hours, subject has a FEV1 =60% and =85% of the predicted value (=65% and =90% of the predicted value if subject is receiving asthma controller medications)
- •While withholding SABAs for at least 6 hours and LABAs for at least 12 hours (at Visit 1 only), subject has evidence of reversibility of airway obstruction defined as an increase of FEV1 of 12% or greater, and at least 200 mL, 10 to 30 minutes after SABA administration, documented once during the screening period
- •Subject’s asthma treatment must fall into one of two categories:
- •oThe subject must have been using only as-needed” inhaled SABAs (e.g., albuterol/salbutamol) and not using asthma controller medications; OR
- •oThe subject must have been receiving stable doses of low- or medium-dose ICS, combination ICS/LABA, and/or other asthma controller medications, including leukotriene receptor antagonists, and can tolerate tapering of these controllers (e.g., ICS) or discontinuing them (e.g., montelukast), during the run-in period
- •Subject has never smoked or is a non-smoker for at least 1 year, with a smoking history of no more than 10 pack-years
- •Subject has a Body Mass Index (BMI) between 15 and 40 kg/m2 inclusive (BMI = weight in kg/[height in meters]2
- •Subject provides written informed consent for the study. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main study without participating in Future Biomedical Research
- •Subject has an ACQ-6 of =1.5 at the Randomization visit
- •Subject has a total daytime and nocturnal SABA administration average =1 puff per day, as recorded on the subject’s e-Diary for the last 7 days prior to Randomization visit
- •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 1480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1480
排除标准
- •Subject is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, unable to read or comprehend written material, or unable to comply with the study procedures or protocol
- •Subject has a recent history (=3 months) of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia prior to Visit 1
- •Subject is hospitalized or has been hospitalized in the 4 weeks prior to Visit 1
- •Subject has undergone any major surgical procedure within the 4 weeks prior to Visit 1
- •Subject has evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD) documented by history, physical examination, or chest x-ray
- •Subject has been treated in an emergency room for asthma within the 4 weeks prior to Visit 1 or has been hospitalized for asthma within the 8 weeks prior to Visit 1
- •Subject has had a respiratory tract infection which necessitated treatment with antibiotics within the 8 weeks prior to Visit 1
- •Subject has evidence of active, clinically significant sinus disease within 1 week prior to Visit 1
- •Subject is hypersensitive to inhaled ß-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their formulation components
- •Subject has evidence of uncontrolled hypertension, defined as systolic >160 mmHg and/or diastolic >100 mmHg, during at least 2 of the first 3 study visits
- •The electrocardiogram (ECG) obtained at Visit 1 demonstrates clinically significant or unexplained abnormality, that may include but is not limited to: a clinically significant conduction disturbance (e.g., second or third degree AV block), clinically significant tachycardia, active cardiac ischemia, or a QTc > 460 msec
- •Subject has used any medication with a narrow therapeutic index (e.g., warfarin, coumadin, dicoumarol, digoxin, digitoxin) within the 2 weeks prior to Visit 1 or plans to take such medications during the study
- •Subject is unable to comply with the study procedures or protocol, including completion of the e-Diary and compliance with study medication
- •Subject experiences a clinically significant worsening of their asthma between Visits 1 and 3.
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