BIOMEDICAL RESEARCH

COPD研究（SPIROMICS）的亚群和中间结局指标：加重子研究<$加重子研究有助于实现SPIROMICS的两个主要目的，即确定1）COPD的同质亚组和2）用作临床试验终点的中间生物学和临床结局指标。急性加重被认为是COPD自然史中的哨兵事件。其频率和严重程度与多种负面影响相关，包括健康状况恶化、肺功能恶化、护理成本增加和死亡率增加。更好地了解这些事件的性质及其症状表现有可能导致更好地了解急性加重的生物学起源，并提供新的治疗方法。 将在基线或临床访视2期间联系同意就参与其他子研究进行联系的受试者，以确定是否有兴趣参与急性加重子研究。然后将筛选有兴趣的参与者并获得参与子研究的知情同意。第一波和第二波将招募400名参与者。虽然每个承包商预计将招募约67名受试者，但重点目标是招募400名参与者。谈判的基础是每个地点招募67名参与者。如果确定一个研究中心能够超过67例的招募目标，而其他研究中心不能，则可能在后续期间进行招募调整。 入组急性加重子研究的受试者将分为以下两个基础之一： 1)亚层1（有急性加重风险的COPD患者）<$过去12个月内有2次或2次以上急性加重史 2)亚层2（无急性加重风险的COPD患者）<$过去12个月内有1次或无急性加重史 为了获得适当的统计把握度，本子研究中纳入的评估不需要整个队列。

SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS): Exacerbation substudy ¿ The Exacerbation Substudy contributes to the two primary aims of SPIROMICS the identification of 1) homogeneous subgroups of COPD and 2) intermediate biological and clinical outcome measures for use as clinical trial endpoints. Exacerbations are considered sentinel events in the natural history of COPD. Their frequency and severity have been associated with multiple negative implications including worsening health status, worsening pulmonary function, increasing cost of care, and increased mortality. A better understanding of the nature of these events and their symptomatic manifestations has the potential of leading to an improved understanding of the biological genesis of exacerbations and provide novel therapeutic approaches. Participants who consented to being contacted about participating in additional substudies will be approached during Baseline or clinic Visit 2 to determine interest in the Exacerbation Substudy. Interested participants will then be screened and consented for the substudy. A total of 400 participants will be enrolled in Wave 1 and 2. While each contractor is expected to enroll approximately 67 subjects, the underlining goal is to enroll 400 participants. Negotiations are based on each site recruiting 67 participants. Recruitment adjustments may occur in subsequent periods if it is determined that one site is able to exceed the recruitment goal of 67 while other sites are not. Participants enrolled into the Exacerbation Substudy will fall into one of two substrata: 1) Sub-stratum one (COPD patients at risk for acute exacerbation) ¿ History of two or more exacerbations in the last 12 months 2) Sub-stratum two (COPD patients not at risk for acute exacerbation) ¿ History of one or no exacerbations in the last 12 months Assessments included in this substudy do not require the full cohort in order to achieve the appropriate statistical power.