Purpose: The LHC Study is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.

Detailed Description: The scientific goal of the study is to establish the relationship between a variety of factors (lifetime environmental exposures, fitness and physical activity, biomarkers, nasal respiratory epithelial transcriptome) and ideal versus impaired peak lung health (reserve and markers of susceptibility in investigators' model) in young adulthood. In addition to the initial baseline assessment, remote contacts (e.g., via text message, email, mail, or phone) at regular intervals will allow for both the retention of the participants as well as the collection of additional short-term follow-up information, i.e., within 4.5 years of enrollment.

Please call (415) 203-8234 for more information about the LHC study.

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Purpose: The objective of this study is to investigate changes in lung function during exercise in asthma patients with obesity and severe asthma patients. Metabolic dysfunction and mucus plugs will be measured in these groups, respectively, to answer the study's aim. 

Detailed Description: Participants will undergo a screening phase comprised of the maximum bronchodilator reversibility and methacholine challenge tests to determine evidence of asthma. Those in the severe asthma group will undergo a CT scan of the lungs to examine the presence of mucus plugs. All eligible participants will complete a Cardiopulmonary Exercise Test (CPET) at the UCSF Pulmonary Function Laboratory. The CPET is a procedure in which lung function is measured before, during, and after a stationary bike exercise test. Additionally, there is one required blood draw which can occur at any visit. 

This study involves 10 hours total for all visits over a span of up to 6 months. 

Please call (415) 476-1783​ for more information on the IMAP study.

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Purpose: The purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.

Detailed Description: The overall objective of this proposal is to understand molecular mechanisms that account for alterations in secretory cell and mucus function that are important in severe asthma. The overarching hypothesis is that local type 2 immune responses induce IL-13-mediated changes in epithelial gene expression and that these changes, which involve several novel molecular mechanisms not previously explored, alter the differentiation of secretory cells and the production and secretion of mucins, leading to mucus plugging and airway obstruction. The proposal includes two highly related projects, each of which focuses on molecules and pathways that have previously unknown roles in secretory cell biology and mucus dysfunction. The proposed studies will provide new mechanistic insights that are highly relevant to the pathogenesis of severe asthma and may lead to novel therapeutic targets that address unmet needs.

Please call 628-233-1233 for more information on the MIBAS study.

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Purpose: This study’s mission is to identify and test how well 6 new therapies work in adult and adolescent patients with severe asthma. Examination of patients’ responses to these therapies, how these therapies work in the body, and safety of these therapies will provide insight into which treatments work best for patients.

Detailed Description: Severe asthma affects 5 – 10% of patients with asthma (~ 2.5 million Americans). Although patients with severe asthma are using currently available treatments, they continue to have poor control, low lung function and/or increased risk of worsening symptoms. The main goal of PrecISE is to find more customized treatments that best fit the needs of patients with severe asthma using biomarkers. Biomarkers are pieces of information gained from various tests (e.g. spirometry, Lung Diffusion Capacity test) and biospecimen collection (e.g. blood samples, urine samples).

This study is an adaptive platform trial design. An adaptive platform trial design is unique in that it allows for testing of multiple treatments at the same time and allows flexibility in the addition and discontinuation of interventions as the study progresses. Participation in PrecISE includes 3 phases. Phase 1 is the initial screening process where participants are screened for eligibility and assigned to interventions. Biomarkers will be the basis for determining which interventions match patients best. Phase 2 involves two rounds of 16-week treatment periods followed by 8- or 16-week washout periods, in which no treatment is taken while the previous treatment is washed out of the body. Phase 3 comprises of single 16-week treatment periods followed by 8- or 16-week washout periods. Interventions are assigned at random to participants and participants undergo at least 2 different treatments.

PrecISE is a national clinical trial funded by the National Heart, Lung, and Blood Institute and headed by the University of North Carolina at Chapel Hill.

PrecISE is currently closed for new enrollment.

Purpose: The mission of SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma. 

Detailed Description: The mission of the SARP is to improve the understanding of severe asthma to develop better treatments. The SARP will gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease. To this end, the SARP investigators will utilize both mechanistic and evoked phenotype approaches to: 1) characterize developmental molecular, cellular and physiologic phenotypes in children and adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time.

This approach involves a shared longitudinal protocol conducted across all participating centers which includes common information on all SARP participants. Additionally, the SARP-SF has identified mechanistic research questions to be included in the shared longitudinal protocol. This will be explored through additional sample collections of sputum and fluids and biopsied tissue collected by bronchoscopy. Together, these longitudinal and mechanistic approaches will enable prediction of phenotype stability/fluctuation and pharmacologic responses and identification of novel, disease-modifying targets for treatment.

SARP is currently closed for new enrollment.

Purpose: The SOURCE study will help identify and define what happens to the lungs in the earliest phases of smoke exposure. This research may eventually lead to the discovery of new ways to prevent or treat COPD. The main goals of this study are to understand how COPD develops by studying the earliest signs of the disease and why some people develop early COPD while others do not. 

Detailed Description: SOURCE is a research study to understand the lung’s response to tobacco smoke exposure. People who smoke can develop changes in their airways and lungs long before they have symptoms that are often linked to COPD, like cough or shortness of breath. Because most studies of COPD have enrolled older individuals, this study will help us better understand the early stages of COPD in younger people. The SOURCE research study is taking place at 14 sites across the United States.

This study will enroll people between 30 and 55 years of age who are current or former cigarette smokers. If enrolled, you’ll have two clinic visits over 3 years to complete breathing tests, a CT scan of the lungs, and other health measures. We’ll also follow up with you over the phone twice each year for 5 years. You do not need a diagnosis of lung disease or COPD to join.

SOURCE is currently closed for new enrollment.

Purpose: The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD), which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD, and it is the fourth leading cause of death in the country. The most common cause of COPD is cigarette smoking, although not all smokers get COPD. The discovery of new treatments for COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to measure whether or not COPD is getting worse.

The study has two main goals. The first is to find groups of patients with COPD who share certain characteristics. Certain groups may respond differently to certain treatments. The second is to find new ways of measuring whether or not COPD is getting worse. This would provide new ways of testing whether a new treatment is working.

It is funded by the National Heart, Lung, and Blood Institute and is coordinated by the University of North Carolina at Chapel Hill.

Detailed Description: There are 3 Aims in this study. Aim 1 is to define the natural history of "Smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 is to determine the radiographic precursor lesion(s) for emphysema, and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.

 Research subjects for SPIROMICS will be enrolled, phenotyped, and followed at twelve SPIROMICS Clinical Centers. Molecular fingerprinting and extensive subject phenotyping will be performed to identify disease subpopulations and to identify and validate surrogate markers of disease severity, which will be useful as intermediate outcome measures for future clinical trials. Secondary aims are to clarify the natural history of COPD, to develop bioinformatic resources that will enable the utilization and sharing of data in studies of COPD and related diseases, and to create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD.

If you would like to learn more about the progress of SPIROMICS please follow the following link: https://www.spiromics.org/spiromics/ 

SPIROMICS is currently closed for new enrollment.

Purpose: The objectives of this study are to learn more about the physical properties of lung mucus in chronic airway diseases and to analyze how these properties are affected by mucolytic drugs.

Detailed Description: Involving up to 4 visits, participants will undergo breathing tests and provide samples of spontaneously expectorated sputum (phlegm). Participants will also be asked to collect samples of sputum at home using a provided collection kit and bring these samples with them to the research center for their visits. A single blood draw may be conducted.

Individuals diagnosed with either asthma, chronic obstructive pulmonary disorder (COPD), or non-cystic fibrosis bronchiectasis, who also often cough up mucus (phlegm) from their lungs may be eligible. 

Please call (415) 502-4328 for more information on the CRAM study.

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Purpose: This study aims to test if delivery of aerosolized NAC with positive inspiratory pressure has a greater effect on mucus plug burden and lung function in the lungs than delivery of NAC without positive pressure.

Detailed Description: 

The optimal method for delivering aerosolized N-acetyl cysteine (NAC, Mucomyst) to the airways to lyse mucus plugs is not established. The challenge is to ensure that the NAC aerosol penetrates the mucus plug to lyse it. This pilot study is designed to inform the optimal method of delivering aerosolized mucolytic drugs to the lungs to lyse mucus plugs and improve lung function. Once established, the optimal method can be used in a larger clinical trial to formally test if lysis of mucus plugs by mucolytic drugs can improve lung function in patients with mucus-high subtypes of asthma and COPD.

Participants will be enrolled in the study for up to 6 months. Participation starts with a screening phase. Eligible participants will undergo five treatment visits over up to 30 days. Two nebulization treatments will be given on each of the five treatment days for 10 treatments. After the treatment phase, participants will complete one follow-up visit within 7 days after the last treatment visit.

Please call (415) 476-1783 for more information on the TEAM study.

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