EUCTR2015-005054-36-PL进行中（未招募）1 期
A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects with Persistent Asthma That is Uncontrolled While Receiving Montelukast. - Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 100 人开始时间: 2016年7月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Male/Female subjects between the ages of 18 and 65
- •Have 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.
- •Must have documented SNP+ test result prior to Visit 2
- •Have acceptable lung function at Visit 2 and Visit 4:
- •FEV1 =55% and =85% of the predicted value (or, =60% and =90% of the predicted value if subject is receiving controllers) at Visit 2, after withholding inhaled beta-agonist bronchodilators prior to spirometry (see section 5.5.1);
- •AND FEV1 =50% and =85% of the predicted value at Visit 4
- •Have evidence of reversibility of airway obstruction, defined as an increase in FEV1 of at least 12% and at least 200mL when measured 10 to 30 minutes following short-acting beta-agonist (SABA)
- •Have a history of asthma treatment, prior to Visit 1, that is in one of two categories (see section 4.2.1.3):
- •Controllers: Receiving stable doses of low- or medium-dose ICS, combination ICS/LABA, and/or other asthma controller medications; and (based on investigator’s judgment) can tolerate tapering of these controllers (e.g., ICS) or discontinuing these controllers (i.e., non-ICS) while receiving montelukast 10mg once daily (QD) starting at Visit 3; OR
- •Non-controllers: Not receiving asthma controller medications, and using only as-needed” inhaled SABAs, for =4 weeks prior to Visit 1.
- •Agree at Visit 3 to discontinue controllers (e.g., leukotriene antagonists other than montelukast), or taper them (e.g., ICS) over 2-4 weeks (as described in Appendix 12.10). Also, agree at Visit 3 to begin montelukast 10 mg QD.
- •Have a 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 Visit 4.
- •Have an ACQ-6 score meeting the following requirements.
- •Non-controllers: At Visit 2, must have an ACQ-6 score =1.5 and a score between 1 and 6 for Question #6. At Visit 4, must have an ACQ-6 score =1.5.
- •Controllers: Visit 4 must have an ACQ-6 score =1.5.
- •Not be pregnant
- •Refer to protocol for complete list
- •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 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Is unable to perform acceptable, repeatable spirometry.
- •Has evidence of another clinically significant, active pulmonary disorder, such as bronchiectasis or COPD, documented by history, physical examination, or chest x-ray.
- •Has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma or respiratory condition within 2 months prior to Visit 1.
- •Has had an upper respiratory tract infection (viral or bacterial) within 1 month prior to Visit 1.
- •Has evidence of active, clinically significant sinus disease within 2 weeks prior to Visit 1.
- •Experiences a clinically significant deterioration of asthma between Visit 2 and Visit 4. A significant deterioration of asthma is defined as one or more of the following:
- •Decrease in absolute FEV1 (in L) by 20% or more from the FEV1 at Visit 2;
- •Decrease in %-predicted FEV1 to less than 50% of the predicted value;
- •Clinical asthma exacerbation requiring emergency treatment, hospital admission (serious AE), or treatment with additional asthma medication (other than SABAs).
- •Refer to protocol for complete list
研究者
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