Neutrophilic Asthma Study With Navarixin (MK-7123, SCH 527123) (MK-7123-017)(COMPLETED)
2018年12月10日 更新者:Merck Sharp & Dohme LLC
Safety of SCH 527123 in Subjects With Neutrophilic Asthma
4-Week Safety Study in Subjects with Neutrophilic Asthma
研究概览
详细说明
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms
研究类型
介入性
注册 (实际的)
37
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 to <=70 years of age, either sex, any race.
- Induced sputum neutrophil count >=40% of total white blood cells and <10 million/mL at Screening.
- Documented diagnosis of asthma (within past 5 years), determined by at least one of the following: >=12% and 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL).
- Nonsmoker or previous smoker with cumulative smoking history less than 20 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening.
- Must not have had an exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.
- Must be receiving >=800 mcg/day of beclomethasone dipropionate (BDP) or equivalent for at least 3 months prior to Screening (and on stable dose for at least 4 weeks prior to Screening).
- Must be willing to give written informed consent to participate in the study
- Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.
- Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
- Male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.
Exclusion Criteria:
- Chronic Obstructive Pulmonary Disease (COPD)/other relevant lung disease (other than asthma).
- 4 weeks prior to/or Screening: upper/lower respiratory tract infection.
- Prohibited medications received more recently than indicated washout prior to Screening
- Screening: Inadequate amount or difficulty producing sputum.
- Screening: Sputum neutrophil count over 10 million/mL.
- Screening: peripheral blood neutrophil (PBN) count <3000/µL.
- Post-bronchodilator FEV1 <1L.
- Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus [HIV], hepatitis B or C).
- Allergy/sensitivity to study drug/excipients.
- Breast-feeding, pregnant/intends to become pregnant during study.
- Requiring mechanical ventilation for respiratory event within 6 months of Screening.
- Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication.
- Within 30 days of Screening: any other investigational drug.
- Participation in any other clinical study.
- Part of the staff personnel involved with the study.
- Family member of investigational study staff.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Navarixin
Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks
|
Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.
Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
|
安慰剂比较:Placebo
Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
|
Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
大体时间:Up to 4 weeks
|
Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period
|
Up to 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mean Change From Baseline in Sputum Absolute Neutrophil Count
大体时间:Baseline and while on study drug (up to 4 weeks)
|
Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period.
Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis.
An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug.
|
Baseline and while on study drug (up to 4 weeks)
|
Mean Change From Baseline in Total Asthma Symptom Score
大体时间:Baseline and Weeks 1, 2, 3, and 4
|
Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card.
Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments.
The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms.
|
Baseline and Weeks 1, 2, 3, and 4
|
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
大体时间:Baseline and up to 4 weeks
|
Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later.
The mean change from baseline is based on the average change over all post-baseline assessments.
|
Baseline and up to 4 weeks
|
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])
大体时间:Baseline and up to 4 weeks
|
The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation.
Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected).
The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments.
|
Baseline and up to 4 weeks
|
Number of Participants With an Adverse Event (AE)
大体时间:Up to 5 weeks
|
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Up to 5 weeks
|
Number of Participants With an Electrocardiogram Adverse Event
大体时间:Week 4
|
The endpoint measured was any electrocardiogram abnormality that was reported as an AE.
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Week 4
|
Number of Participants With a Laboratory Adverse Event
大体时间:Up to 5 weeks
|
The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE.
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Up to 5 weeks
|
Number of Participants Who Discontinued the Study Because of an Adverse Event
大体时间:Up to 5 weeks
|
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Up to 5 weeks
|
Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event
大体时间:Up to 4 weeks
|
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator.
|
Up to 4 weeks
|
Maximum Plasma Concentration of Navarixin (Cmax)
大体时间:Week 1, 2, 3, and 4
|
Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4
|
Week 1, 2, 3, and 4
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2008年5月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2008年2月29日
首先提交符合 QC 标准的
2008年2月29日
首次发布 (估计)
2008年3月10日
研究记录更新
最后更新发布 (实际的)
2019年1月2日
上次提交的符合 QC 标准的更新
2018年12月10日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Navarixin的临床试验
-
Merck Sharp & Dohme LLC终止