A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
2016年12月19日 更新者：Janssen Research & Development, LLC
A Multicenter Longitudinal Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
The purpose of this study is to characterize the clinical, physiologic, and molecular profiles of healthy participants, participants with mild, moderate, and severe asthma; and participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
研究概览
详细说明
This is a multi-center, longitudinal (participants are followed over long period of time with continuous or repeated observations of health outcomes) exploratory study (biomarkers, clinical and physiological parameters for participants with asthma and COPD are observed for the first time).
This study will be conducted in 2 parts.
Part 1 will include healthy participants and participants with mild, moderate, and severe asthma.
Part 2 will include healthy nonsmokers, healthy asymptomatic smokers, and participants with moderate and or severe COPD.
Study participants will undergo medical tests that will include pulmonary function testing, assessment of airway reactivity, bronchoscopy procedure, blood samples for routine laboratory tests, biomarkers and DNA evaluation (for some study participants), induced sputum collection, and exhaled nitric oxide collection.
Safety evaluations will includes assessment of adverse events, clinical laboratory tests, 12-lead electrocardiogram, vital signs, and physical examinations.
研究类型
介入性
注册 (实际的)
328
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kobenhavn Nv、丹麦
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Alberta
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Calgary、Alberta、加拿大
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British Columbia
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Vancouver、British Columbia、加拿大
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Quebec
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Montreal、Quebec、加拿大
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Sainte Foy、Quebec、加拿大
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Frankfurt、德国
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Lübeck、德国
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Bordeaux Pessac N/A、法国
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Marseille、法国
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Bucuresti、罗马尼亚
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Alabama
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Birmingham、Alabama、美国
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Connecticut
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New Haven、Connecticut、美国
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Illinois
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Chicago、Illinois、美国
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Iowa
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Iowa City、Iowa、美国
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Maryland
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Baltimore、Maryland、美国
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North Carolina
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Chapel Hill、North Carolina、美国
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Ohio
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Cleveland、Ohio、美国
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Pennsylvania
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Philadelphia、Pennsylvania、美国
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Texas
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Galveston、Texas、美国
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Manchester、英国
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Rotterdam、荷兰
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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:
- Age: for Part 1, healthy: 18 and 55 years; for Part 1, asthma: 18 and 70 years; for Part 2, nonsmokers: 40 and 65 years; for Part 2, smokers: 40 and 65 years; for Part 2, chronic obstructive pulmonary disease (COPD): 40 and 65 years
- Having mild, moderate, or severe asthma (for Part 1, asthma)
- Clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for Part 1, asthma)
- No history of chronic respiratory disease including asthma (for Part 2, nonsmokers)
- Be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all Part 1 and Pat 2, nonsmokers)
- Be a current smoker with a current history of at least 20 pack years (for Part 2, smokers)
- Stable COPD in the 3 months prior to screening (for Part 2, COPD)
- Treating with Beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for Part 2, COPD)
Exclusion Criteria:
- History of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all Part 1 and Part 2)
- Positive urine screen for nicotine; positive serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening (for all Part 1 and Part 2)
- Allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for Part 1, asthma)
- Requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for Part 2, COPD)
- Pneumonia, COPD exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for Part 2, COPD)
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：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：所有参与者
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All participants will undergo medical tests and will be observed.
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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 |
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Asthma Quality of Life Questionnaire (AQLQ) score
大体时间：Baseline (5 to 14 days after screening), Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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AQLQ is used to measure the physical, emotional, social and occupational problems for participants with asthma.
There are 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli) to measure activity limitation and symptom frequency using a recall period of 2 weeks.
Each 32 questions are on a 7-point scale (7 = not impaired at all and 1 = severely impaired).
The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.
Lower scores indicate worsening.
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Baseline (5 to 14 days after screening), Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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Asthma Control Questionnaire (ACQ) score
大体时间：Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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ACQ is used to evaluate asthma control, the full range of clinical impairment (well controlled to life threatening) for the participant with asthma.
There are 7 questions (5 for symptoms [night-time awakenings, morning symptoms, limitation of activities, shortness of breath, and wheezing], use of daily rescue bronchodilator, and percent predicted forced expiratory volume value).
All 7 items are scored on a 7-point scale (0 = good control, 6 = poor control), with the mean score as an overall summary score.
The recall period is 7 days.
Higher scores indicate worsening.
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Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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Forced Expiratory Volume in 1 second (FEV1) value
大体时间：Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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FEV1 will be measured by using spirometry test.
Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled.
Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer.
Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.
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Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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Forced Vital Capacity (FVC) value
大体时间：Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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FVC will be measured by using spirometry test.
Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled.
Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer.
Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.
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Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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Forced Expiratory Flow (FEF) 25-75 value
大体时间：Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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FEF is the flow of air coming out of the lung during the middle portion of a forced expiration.
It is generally defined by what fraction remains of the forced vital capacity (FVC), usually 25-75 percent (FEF25-75%).
Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.
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Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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Peak Expiratory Flow Rate (PEFR)
大体时间：Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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PEER will be measures by using spirometry test.
Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled.
Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer.
Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.
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Screening, Baseline, 5 to 14 days after baseline (for Part 1: healthy participants); and Month 3, Month 6, and Month 12 (for Part 1: participants with asthma and for all Part 2 participants)
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Methacholine challenge
大体时间：Screening or Baseline (for Part 1: participants with asthma)
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Methacholine challenge test is used to assess airway reactivity in asthma.
In this test, baseline spirometry for participant is measured by inhalation of increasing concentrations of aerosolized methacholine up to 16 mg/mL.
The provocative dose (PC20) is defined as the dose of methacholine required to cause a greater than or equal to 20 percent decrease from the baseline forced expiratory volume in 1 second value.
A PC20 result of less than or equal to 16 mg/mL will be considered to reflect increase airway responsiveness for fulfilling eligibility criteria.
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Screening or Baseline (for Part 1: participants with asthma)
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Fractional Exhaled Nitric Oxide (FENO)
大体时间：Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma); and 5 to 14 days after baseline (for Part 2: participants with chronic obstructive pulmonary disease)
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Measurement of FENO is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to assessing airways disease.
The participant can exhale directly into a measurement device, or into a reservoir that can afterwards be connected to the analyzer.
With the former technique, the early and later nitric oxide in the breath sample can be analyzed separately.
Two replicate FENO measurements will be obtained that agree at the 10% level and up to a total of 8 measurements will be performed to achieve this level of agreement.
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Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma); and 5 to 14 days after baseline (for Part 2: participants with chronic obstructive pulmonary disease)
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Induced sputum
大体时间：Screening, Baseline (for Part 1: healthy participants and for all Part 2 participants); and Month 6 (for Part 1: participants with asthma)
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Screening, Baseline (for Part 1: healthy participants and for all Part 2 participants); and Month 6 (for Part 1: participants with asthma)
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Saint George's Respiratory Questionnaire score for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
大体时间：Baseline (for Part 2: participants with COPD)
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SGRQ-C is a 14-item questionnaire designed to measure health impairment in participants with COPD.
The SGRQ-C has 2 parts.
Part 1 generates the Symptoms score, and Part 2 generates the Activity and Impacts scores.
Total score (0 to 100) is the sum of all scores.
Higher scores indicate greater health impairment.
Higher score indicate worsening.
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Baseline (for Part 2: participants with COPD)
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EXACT-Respiratory Symptoms (E-RS)
大体时间：Baseline (for Part 2: participants with chronic obstructive pulmonary disease)
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E-RS is a 11 respiratory system items scoring algorithm to assess the severity of respiratory symptoms in participants with Chronic Obstructive Pulmonary Disease (COPD).
Each item has either 5 or 6 response options.
Higher score indicate more severe COPD.
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Baseline (for Part 2: participants with chronic obstructive pulmonary disease)
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Number of participants with adverse events
大体时间：Up to 1 month (for Part 1: healthy participants and for all Part 2 participants); and Up to 1 year (for Part 1: participants with asthma)
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Up to 1 month (for Part 1: healthy participants and for all Part 2 participants); and Up to 1 year (for Part 1: participants with asthma)
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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。
一般刊物
- Cass SP, Yang Y, Xiao J, McGrath JJC, Fantauzzi MF, Thayaparan D, Wang F, Liang Z, Long F, Stevenson CS, Chen R, Stampfli MR. Current smoking status is associated with reduced sputum immunoglobulin M and G expression in COPD. Eur Respir J. 2021 Feb 4;57(2):1902338. doi: 10.1183/13993003.02338-2019. Print 2021 Feb. No abstract available.
- Loza MJ, Djukanovic R, Chung KF, Horowitz D, Ma K, Branigan P, Barnathan ES, Susulic VS, Silkoff PE, Sterk PJ, Baribaud F; ADEPT (Airways Disease Endotyping for Personalized Therapeutics) and U-BIOPRED (Unbiased Biomarkers for the Prediction of Respiratory Disease Outcome Consortium) investigators. Validated and longitudinally stable asthma phenotypes based on cluster analysis of the ADEPT study. Respir Res. 2016 Dec 15;17(1):165. doi: 10.1186/s12931-016-0482-9.
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
2010年7月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年7月1日
研究注册日期
首次提交
2010年10月28日
首先提交符合 QC 标准的
2011年1月10日
首次发布 (估计)
2011年1月11日
研究记录更新
最后更新发布 (估计)
2016年12月20日
上次提交的符合 QC 标准的更新
2016年12月19日
最后验证
2014年9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.