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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).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

328

段階

  • 初期フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ
    • Connecticut
      • New Haven、Connecticut、アメリカ
    • Illinois
      • Chicago、Illinois、アメリカ
    • Iowa
      • Iowa City、Iowa、アメリカ
    • Maryland
      • Baltimore、Maryland、アメリカ
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ
    • Ohio
      • Cleveland、Ohio、アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ
    • Texas
      • Galveston、Texas、アメリカ
  • イギリス
      • Manchester、イギリス
  • オランダ
      • Rotterdam、オランダ
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ
    • Quebec
      • Montreal、Quebec、カナダ
      • Sainte Foy、Quebec、カナダ
  • デンマーク
      • Kobenhavn Nv、デンマーク
  • ドイツ
      • Frankfurt、ドイツ
      • Lübeck、ドイツ
  • フランス
      • Bordeaux Pessac N/A、フランス
      • Marseille、フランス
  • ルーマニア
      • Bucuresti、ルーマニア

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：参加者全員
他の：Medical tests
All participants will undergo medical tests and will be observed.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Asthma Quality of Life Questionnaire (AQLQ) score
時間枠：Baseline (5 to 14 days after screening), Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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.
Baseline (5 to 14 days after screening), Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
Asthma Control Questionnaire (ACQ) score
時間枠：Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
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.
Baseline, Month 3, Month 6, and Month 12 (for Part 1: participants with asthma)
Forced Expiratory Volume in 1 second (FEV1) value
時間枠：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)
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.
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)
Forced Vital Capacity (FVC) value
時間枠：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)
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.
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)
Forced Expiratory Flow (FEF) 25-75 value
時間枠：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)
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.
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)
Peak Expiratory Flow Rate (PEFR)
時間枠：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)
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.
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)
Methacholine challenge
時間枠：Screening or Baseline (for Part 1: participants with asthma)
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.
Screening or Baseline (for Part 1: participants with asthma)
Fractional Exhaled Nitric Oxide (FENO)
時間枠：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)
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.
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)
Induced sputum
時間枠：Screening, Baseline (for Part 1: healthy participants and for all Part 2 participants); and Month 6 (for Part 1: participants with asthma)
Screening, Baseline (for Part 1: healthy participants and for all Part 2 participants); and Month 6 (for Part 1: participants with asthma)
Saint George's Respiratory Questionnaire score for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
時間枠：Baseline (for Part 2: participants with COPD)
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.
Baseline (for Part 2: participants with COPD)
EXACT-Respiratory Symptoms (E-RS)
時間枠：Baseline (for Part 2: participants with chronic obstructive pulmonary disease)
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.
Baseline (for Part 2: participants with chronic obstructive pulmonary disease)
Number of participants with adverse events
時間枠：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)
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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年7月1日

一次修了 (実際)

2014年7月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2010年10月28日

QC基準を満たした最初の提出物

2011年1月10日

最初の投稿 (見積もり)

2011年1月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年12月20日

QC基準を満たした最後の更新が送信されました

2016年12月19日

最終確認日

2014年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CR017362
  • NOCOMPOUNDASH0001 (その他の識別子：Janssen Research & Development, LLC)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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