EUCTR2012-000642-35-DE进行中（未招募）不适用
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects with Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast - Crossover Study of MK-1029 in Adults with Persistent Asthma Receiving Montelukast
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
- 100
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 and and has an elevated blood eosinophil count and/or serum IgE.
- •While withholding SABAs for at least 6 hours and LABAs for at least 14 hours (withholding LABAs for 12-14 hours is acceptable, but not preferred), subject has a FEV1 =60% and =85% of the predicted value (=65% and =90% of the predicted value if subject is receiving controllers)
- •While withholding SABAs for at least 6 hours and LABAs for at least 12 hours, 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 ß-agonist administration.
- •Subject’s asthma treatment must fall into one of two categories:
- •- The subject must have been using only as-needed” inhaled short acting ß agonists (albuterol/salbutamol) and not using inhaled corticosteroids (ICS) or combination ICS and long-acting ß-agonists (ICS/LABA); OR
- •- The subject must have been on a stable dose of ICS or combination ICS/LABA (any dose) for at least 4 weeks prior to Visit 1 and must be able to tolerate tapering of ICS or combination ICS/LABA to montelukast 10 mg QD
- •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 (i.e., 1 pack [20 cigarettes] per day for 10 years)
- •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 94
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •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 4 weeks prior to Visit 1
- •Subject has evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or COPD documented by history, physical examination, or chest x-ray
- •Subject has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma within 2 months prior to Visit 1
- •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 (Visit 1, Visit 2, and Visit 3)
- •Screening electrocardiogram (ECG) 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 2 weeks prior to Visit 1 or plans to take such medications during the study.
研究者
相似试验
进行中（未招募）
1 期
A study to test the efficacy and safety of Staccato alprazolam in study participants 12 years of age and older with epilepsyTreatment of stereotypical prolonged seizureMedDRA version: 20.0Level: LLTClassification code 10076333Term: Prolonged seizureSystem Organ Class: 100000004852EUCTR2021-002686-18-CZCB Biopharma SR200
进行中（未招募）
1 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK-0633 in Adult Patients with Chronic Asthma - MK-0633 Asthma Dose-Ranging Phase IIb studyTreatment of asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2008-005061-57-HUMerck & Co., Inc.828
进行中（未招募）
不适用
A study in adults who have ongoing asthma, using a new product at different doses.Adult subjects 18 to 75 years of age with persistent asthmaMedDRA version: 15.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-000643-27-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,480
进行中（未招募）
1 期
A study to test the efficacy and safety of Staccato alprazolam in study participants 12 years of age and older with epilepsyEUCTR2021-002686-18-ITCB Biopharma SR200
进行中（未招募）
不适用
A study in adults who have ongoing asthma, using a new product at different dosesAdult subjects 18 to 75 years of age with persistent asthmaMedDRA version: 14.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855EUCTR2012-000643-27-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,480