Allergen Challenge for Evoked Phenotypes in Asthma ("ACE")
Purpose: This protocol describes an NIH-funded, single site mechanistic study to investigate microRNAs (miRNAs) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge.
Detailed Description: A three-visit study is proposed involving detailed subject characterization at baseline; bronchoscopy with segmental allergen challenge (either cat or dust mite, as determined by skin prick testing response); and repeat bronchoscopy either 24 hours or 7 days later for airway biospecimen collection from the sites of allergen and diluent challenge.
Please call 415-502-2892 for more information on the ACE study.
Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program ("CAESAR")
Purpose: CAESAR is a study to understand the mechanisms behind abnormally elastic sputum seen in a proportion of asthmatic people. Sputum of abnormally high elasticity is more difficult to cough up and can contribute to airflow obstruction.
Detailed Description: Asthma is a heterogeneous disease characterized by airway hyperreactivity and chronic airway inflammation. Published literature from the last few years has shown that asthma does not behave like a single disease but is more of a syndrome with vast heterogeneity in pathogenesis, severity, and treatment response. Various clinical phenotypes and endotypes have been described that advance our understanding of these differences and the mechanisms underlying them. We propose there is a subgroup of asthmatic patients that have sputum with abnormal biophysical properties. We will, through CAESAR, recruit subjects with moderate to severe airflow obstruction. We will perform rheological measurement on all subjects that are recruited to our site and from this identify a group of asthmatic cases that have an elastic modulus of ≥1 or <1 and compare properties of sputum from these subjects to healthy controls.
Please call 415-502-3472 for more information on the CAESAR study.
Characterization of Adult Subjects for Asthmatic Research Studies ("CASA")
Purpose:The purpose of this study is to characterize subjects in terms of the nature and severity of asthma and in terms of conditions that may alter the clinical expression of asthma. The study is short but can facilitate enrollment into other asthma clinical research studies at UCSF.
Detailed Description: This is a study in patients with asthma and healthy controls in which subjects will be characterized in terms of the nature and severity of asthma and in terms of conditions that may alter the clinical expression of asthma. Characterization involves obtaining a medical history and breathing tests, sputum analysis, and blood tests. Using these tests we can evaluate how different types of asthma are related to different kinds of inflammation and we can determine if volunteers may have additional research studies available to them for their participation.
Please call 415-514-1539 for more information on the CASA study.
Mechanisms of Exacerbation in Asthma ("MECA")
Purpose: The purpose of this study is to investigate the mechanisms which make individuals susceptible to asthma exacerbations and to examine the characteristics of airway secretions in acute severe asthma. In this study, we will collect sputum or tracheal aspirates from patients with asthma in the emergency room, hospital ward, or ICU to quantify airway inflammation and biophysical properties. Tracheal aspirates will also be collected from non-asthma patients hospitalized for other reasons. Asthmatic patients may also be asked to complete a follow-up characterization visit 4-16 weeks after the acute asthma exacerbation. This visit will be to confirm a diagnosis of asthma and procedures will include spirometry, bronchodilator reversibility or methacholine challenge test, blood sampling and additional sputum collection.
Please call 415-514-1539 for more information on the MECA study.
Inpatient Clinical Trial of NAC in Asthma ("ICON")
Purpose: This study will look at the effects of a medication, called n-acetylcysteine or NAC, on lung function. NAC is already approved for use in people with chronic airway conditions, including asthma. However, it is not known who this medication works best in. We believe this medication will likely have the most benefit in people with asthma that have mucus in their airways or “mucus plugging.” Initial study procedures will include measurements of your lung function, a low dose CT scan, a blood draw, and a sputum induction. The CT lung imaging will identify asthmatics with mucus plugs. Those who demonstrate mucus plugging will then be admitted to the hospital for 6 days and 5 nights. During this time, participants will be given active study drug, 20% NAC, mixed with albuterol, via nebulizer four times a day under the supervision of a registered nurse. After the hospital stay, participants will be followed for 3 additional months as outpatients to track changes in CT lung scans. Total duration of participation will be four months.
Please call 415-514-1539 for more information on the ICON study.
Severe Asthma Research Program ("SARP")
Purpose: The purpose of this study 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 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. 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.
Sorting and Expression Profiling of Airway Cells from Humans ("SEARCH")
Purpose: Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Detailed Description: This is a single-site, longitudinal, mechanistic study of asthmatics and health controls. The primary objective of this study is to identify airway epithelial epigenetic enhancer signatures in asthma. Additionally, we plan to investigate the stability of Type-II and Non-Type-II pathways that are dysregulated in asthma by comparing and performing gene expression profiling on baseline and longitudinal samples. Study participation involves a characterization visit and baseline bronchoscopy, followed by a one-year sputum induction and a one-year bronchoscopy.
Please call 415-502-2892 for more information on the SEARCH study.
COPD STUDIES (Emphysema, Chronic Bronchitis)
Subpopulations and Intermediate Outcome Measures in COPD ("SPIROMICS")
Purpose:Subpopulations and intermediate outcome measures in COPD study (SPIROMICS) is an observational (no drug) study that supports the prospective collection and analysis of phenotypic, biomarker, genetic, genomic, and clinical data from subjects with COPD for the purpose of identifying subpopulations and intermediate outcome measures. 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: Research subjects for SPIROMICS will be enrolled, phenotyped, and followed at six SPIROMICS Clinical Centers (in Winston-Salem, NC; Ann Arbor, MI; San Francisco, CA; Los Angeles, CA; New York City, NY; and Salt Lake City, UT). 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.
SPIROMICS is currently closed for new enrollment.
Beta-Blockers for the Prevention of Acute Exacerbations of COPD ("BLOCK-COPD")
Purpose:A research study testing metoprolol succinate to reducing the risk of COPD exacerbations as compared to placebo in individuals with moderate to severe COPD.
Please call 415-476-5418 for more information on the BLOCK-COPD study.
INSIGHT COPD ("INSIGHT COPD")
A healthy lifestyle program that promotes modest weight loss and increased physical activity. The research team hopes that the program will lead to weight loss, increased physical activity, less shortness of breath, and improved quality-of-life.
Please call 415-476-5418 for more information on the INSIGHT COPD study.
Losartan Effects on Emphysema Progression ("LEEP")
This research is being done to see if a medicine used to treat high blood pressure, Losartan, can slow the damage to the lungs in people who have COPD with emphysema.
Please call 415-476-5418 for more information on the LEEP study.
Redefining Therapy in Early COPD ("RETHINC")
Purpose:A research study which aims to determine if current or former smokers with lung-related and/or breathing problems but normal breathing tests (spirometry) will benefit from the use of a bronchodilator.
Please call 415-476-5418 for more information on the RETHINC study.
Chronic Refractory Cough Cohort Study ("COCO")
This is a study of 100 patients with chronic refractory cough that will be used to determine the statistical and psychometric properties of the cough questionnaires that can be used to design a formal clinical trial, establish whether it is feasible to identify and accrue such patients in a trial, and establish if zinc deficiency is prevalent in patients with chronic refractory cough. The time commitment for this study is 1 month.
Please call 415-476-5418 for more information on the COCO study.
CYSTIC FIBROSIS STUDIES
Preventing Fucose-dependent Binding of Aspergillus and Pseudomonas to Lung Mucin ("CADET")
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.
Detailed Description: 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.
Please call 415-514-1539 for more information on the CADET study.