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itemprop="item" itemtype="https://schema.org/Thing" id="navbar--breadcrumb--link-1"> Home <meta itemprop="name" content="UCSF Clinical Trials"> </a> <meta itemprop="position" content="1"></li><li itemprop="itemListElement" itemscope itemtype="https://schema.org/ListItem"> <a href="https://clinicaltrials.ucsf.edu/chronic-obstructive-pulmonary-disease" itemscope="itemscope" itemprop="item" itemtype="https://schema.org/Thing" aria-description="See all trials related to Chronic Obstructive Pulmonary Disease" id="navbar--breadcrumb--link-2"> <span itemprop="name">Chronic Obstructive Pulmonary Disease</span> Studies </a> <meta itemprop="position" content="2"></li><li class="active">This trial</li></ol></div> <div><div class="d-none d-md-block navbar-text"><form method="GET" action="https://clinicaltrials.ucsf.edu/" class="form-inline my-1" role="search"> <label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><h1 id="summary--title"> SPIROMICS Study of Early COPD Progression (SOURCE) </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../chronic-obstructive-pulmonary-disease">Chronic Obstructive Pulmonary Disease</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 30-55</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-check-circle fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Healthy Volunteers</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>healthy people welcome</strong> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2021-09-08">September 2021</time></span></div><div> completion around <time datetime="2025-04-30">April 2025</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2021-09-05"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/prescott.woodruff" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Prescott G. Woodruff, MD, MPH</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=189259" alt="Headshot of Prescott G. Woodruff" loading="lazy"><figcaption class="figure-caption">Prescott G. Woodruff</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>This is an observational study of 1000 participants to further define the nature of early <a href="../chronic-obstructive-pulmonary-disease" class="trial--link-to-condition-in-text">chronic obstructive pulmonary disease</a> (COPD) in younger, at-risk individuals.</p><p>The study has three main goals:</p><ul><li> To use CT scan imaging to identify which smokers will develop COPD.</li><li> To identify biomarkers predictive of smokers that will develop COPD.</li><li> To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD.</li></ul><p>Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> COPD, Early-Onset</span>, <span> Gold 0</span>, <span> Preserved Ratio Impaired Spirometry (PRISm)</span>, <span> GOLD 1 - 2</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 30-55</strong></p><ul><li>40 of the 1000 will be healthy controls: ages 30-55 years; with no <a href="../smoking-cessation" class="trial--link-to-condition-in-text">smoking</a> history (< 100 cigarettes in lifetime), including vaping and <a href="../cannabis" class="trial--link-to-condition-in-text">cannabis use</a>; pre-bronchodilator FEV1/FVC > 0.70; pre-bronchodilator FEV1 > 80% predicted; pre-bronchodilator FVC > 80% predicted; Chronic Airway Assessment Test (CAAT) score < 10. Willingness to also participate in the bronchoscopy sub-study is only required of the 20 healthy controls recruited from the clinical centers participating in the sub-study.</li><li>Approximately one-third of the 960 will be GOLD 0 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 > 80% predicted.</li><li>Approximately one-third of the 960 will be Preserved Ratio Impaired Spirometry (PRISm) participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 < 80% predicted.</li><li>Approximately one-third of the 960 will be GOLD 1-2 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 > 50% predicted.</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ul><li>Severe asthma, which is defined as any of the following: <ul><li> Current (i.e., at the time of the visit) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroids (ICS)/long-acting beta agonist (LABA) or high dose ICS or add-on long-acting muscarinic agonist (LAMA); Medium dose > 250 fluticasone propionate, = 100 fluticasone furoate, > 200 beclomethasone, > 400 budesonide, > 220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS; or</li><li> Three or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months; or</li><li> One asthma hospitalization in the past 12 months.</li></ul></li><li>Concurrent participation in a therapeutic trial where treatment is blinded.</li><li>Active <a href="../pregnancy" class="trial--link-to-condition-in-text">pregnancy</a> at the time of the baseline visit or planning to become pregnant during the course of the study. This special population is being excluded to minimize potential for fetal radiation exposure.</li><li>Cognitive dysfunction that prevents the participant from completing study procedures.</li><li>BMI > 35.0 kg/m<sup>2</sup> at baseline, due to the effects of body weight on CT scan imaging quality.</li><li>The presence of a respiratory condition other than COPD (including <a href="../bronchitis" class="trial--link-to-condition-in-text">chronic bronchitis</a> and <a href="../emphysema" class="trial--link-to-condition-in-text">emphysema</a>) or asthma, such as <a href="../interstitial-lung-disease" class="trial--link-to-condition-in-text">interstitial lung disease</a> or <a href="../fibrosis" class="trial--link-to-condition-in-text">pulmonary fibrosis</a>, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g., dyspnea or decreased exercise tolerance).</li><li>Any illness expected to cause mortality in the next three years.</li><li>Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.</li><li>History of thoracic radiation or thoracic surgery with resection of lung tissue.</li><li>Known HIV/AIDS infection.</li><li>Current illicit <a href="../substance-abuse" class="trial--link-to-condition-in-text">substance abuse</a>, excluding marijuana.</li><li>History of or current use of IV Ritalin.</li><li>History of or current use of heroin.</li><li>History of illegal IV <a href="../drug-use" class="trial--link-to-condition-in-text">drug use</a> within the last 10 years or more than 5 instances of illegal IV drug use ever.</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94143</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">University of California Los Angeles</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Los Angeles</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 90095</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/prescott.woodruff" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Prescott G. Woodruff, MD, MPH</a> </strong> </span><br> I. Mentoring in Translational Research II. The identification of molecular sub-phenotypes of asthma and COPD III. Mechanisms of airway inflammation and remodeling in lung diseases IV. Development of blood-based diagnostic tests for lung disease using genomic approaches V. Clinical Trials in asthma and COPD </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2021-09-08">September 2021</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2025-04-30">April 2025</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Weill Medical College of Cornell University</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT05033990" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT05033990</a> </dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Observational</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">Expecting 1000 study participants</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-03-25">March 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div><div class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? 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