A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
2016년 12월 19일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
328
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rotterdam, 네덜란드
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Kobenhavn Nv, 덴마크
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Frankfurt, 독일
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Lübeck, 독일
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Bucuresti, 루마니아
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Alabama
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Birmingham, Alabama, 미국
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Connecticut
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New Haven, Connecticut, 미국
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Illinois
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Chicago, Illinois, 미국
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Iowa
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Iowa City, Iowa, 미국
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Maryland
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Baltimore, Maryland, 미국
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North Carolina
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Chapel Hill, North Carolina, 미국
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Ohio
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Cleveland, Ohio, 미국
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Pennsylvania
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Philadelphia, Pennsylvania, 미국
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Texas
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Galveston, Texas, 미국
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Manchester, 영국
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Alberta
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Calgary, Alberta, 캐나다
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British Columbia
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Vancouver, British Columbia, 캐나다
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Quebec
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Montreal, Quebec, 캐나다
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Sainte Foy, Quebec, 캐나다
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Bordeaux Pessac N/A, 프랑스
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Marseille, 프랑스
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 모든 참가자
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All participants will undergo medical tests and will be observed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Asthma Quality of Life Questionnaire (AQLQ) score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 7월 1일
기본 완료 (실제)
2014년 7월 1일
연구 완료 (실제)
2014년 7월 1일
연구 등록 날짜
최초 제출
2010년 10월 28일
QC 기준을 충족하는 최초 제출
2011년 1월 10일
처음 게시됨 (추정)
2011년 1월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 12월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 12월 19일
마지막으로 확인됨
2014년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .