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.

Click here to enroll in our Asthma Studies

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.

Click here to enroll in our Asthma Studies

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.

Click here to enroll in our Asthma Studies

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.

Click here to enroll in our Asthma Studies

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: _

Detailed Description: _

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

Click here to enroll in our Asthma Studies

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 investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum.

This study has two hypotheses: 1) Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds. 2) Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum.

Detailed Description: Pseudomonas lung infection is a major cause of morbidity and mortality occurring in multiple clinical settings. Patients with cystic fibrosis have lung colonization with Pseudomonas from an early age, and overwhelming pseudomonal lung infection is the most common cause of death in these patients. In addition, Pseudomonas pneumonia is common in immunocompromised patients and in patients intubated for management of respiratory failure. Particularly worrisome is the increasing frequency of P. aeruginosa isolates that are resistant to all or most currently available antibiotics. The mechanism of virulence of P. aeruginosa includes soluble lectins that recognize host oligosaccharides on mucins and the cell glycocalyx. P. aeruginosa has two soluble lectins - LecA, also known as PA-IL and LecB, also known as PA-IIL. PA-IL binds galactose and PA-IIL binds fucose. Notably, PA-IIL binds the fucose containing Lewis a oligosaccharide with very high affinity and the role of PA-IIL in biofilm formation is shown by the absence of biofilm formation in Pseudomonas mutants lacking PA-IIL and by the efficacy of multivalent fucosyl-peptide dendrimers in preventing and disrupting Pseudomonas biofilm formation. D-galactose and L-fucose have been successfully used to treat P. aeruginosa infection in a case report, which hints at the potential for glycomimetic therapy in CF. These monosaccharides are weak inhibitors of PA-IIL, however, and multivalent glycomimetics will be needed for more effective inhibition.

Aspergillus fumigatusinfection is responsible for the majority of human and animal aspergillosis disease, even though air sampling studies show that its conidia usually comprise only a small percentage of total airborne fungal challenge. It is both a primary and opportunistic pathogen, and it is particularly troublesome for patients with cystic fibrosis. It causes multiple lung diseases, includingchronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, and invasive pulmonary aspergillosis. Aspergillomas also occur in patients with cavitary lung diseases. Together, these diseases cause significant morbidity and mortality, and available treatments are suboptimal. Most patients with chronic pulmonary aspergillosis require antifungal therapy for many months or years, many experience significant drug side effects, and some experience drug resistance. Patients with either allergic bronchopulmonary aspergillosis (ABPA) or severe asthma with fungal sensitization can improve with itraconazole treatment, but relapses are common, and itraconazole affects corticosteroid metabolism and has the potential to worsen steroid side effects. ABPA requires long-term treatment because Aspergillus airway colonization is difficult to eradicate and quickly recurs when treatment is stopped. Immunocompromised patients are especially vulnerable to invasive aspergillosis where the mortality rate is often 50%, even with antifungal treatment. Clearly, therefore, new treatment approaches are needed for lung diseases caused by A. fumigatus, and we are proposing an approach based on prevention of binding to airway mucins. Adherence of A. fumigatus conidia to host tissues has been the subject of extensive research, but little attention has been directed to Aspergillus/mucin interactions, a surprising deficiency given the role mucins play in airway biology.

This study is an ex-vivo study in which we will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) ex-vivo assessment of the effects of carbohydrates on the rheologic properties of the sputum.

CADET is currently closed for new enrollment.

Click here to enroll in our Cystic Fibrosis Studies

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.

Click here to enroll in our Cystic Fibrosis Studies