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ASTHMA STUDIES

  1. Allergen Challenge for Evoked Phenotypes in Asthma ("ACE")
  2. Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program ("CAESAR")
  3. Characterization of Adult Subjects for Asthmatic Research Studies ("CASA")
  4. Clinical Trial of NAC in Asthma ("CONA")
  5. Role of microRNAs in T Cell-Driven Inflammation in Asthma ("RITA")
  6. Severe Asthma Research Program ("SARP")
  7. Steroids in Eosinophil Negative Asthma ("SIENA")

COPD STUDIES

  1. Subpopulations and Intermediate Outcome Measures in COPD ("SPIROMICS")

CYSTIC FIBROSIS STUDIES

  1. Preventing Fucose-dependent Binding of Aspergillus and Pseudomonas to Lung Mucin ("CADET")

ASTHMA STUDIES

1. 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.

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2. 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.

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3. 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 1-866-2-INHALE for more information on the CASA study.

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4. Clinical Trial of NAC in Asthma ("CONA")

Purpose: Mucus plugging of the airway is consistently found in fatal and near-fatal asthma. The role of mucus as a cause of airflow obstruction in acute severe asthma suggests that mucus plays a role in the pathophysiology of airflow obstruction in chronic severe asthma as well.

Detailed Description: n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs. Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction. This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.

Please call 415-514-1539 for more information on the CONA study.

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5. Role of microRNAs in T Cell-Driven Inflammation in Asthma ("RITA")

Purpose: The purpose of this study is to investigate the role of microRNAs in Th2-driven inflammation in asthma.

Detailed Description: This is a single center study of asthmatic subjects and healthy controls which will investigate mechanisms of asthma through detailed molecular analysis of airway tissues and fluids. The investigators hypothesize that asthma is associated with abnormal expression of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven inflammation and that abnormalities in T cell miRNA expression will be most prominent in a subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers that the investigators have previously established). Finally, the investigators hypothesize that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also facilitate the pursuit of secondary analyses designed to investigate mechanisms of inflammation and remodeling in asthma as well as molecular phenotypes of asthma.

Please call 1-866-2-INHALE for more information on the RITA study.

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6. 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.

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7. Steroids in Eosinophil Negative Asthma ("SIENA")

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: SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).

Please call 1-866-2-INHALE for more information on the SIENA study.

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COPD STUDIES (Emphysema, Chronic Bronchitis)

1. 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.

Please call 415-797-PULM (415-797-7856) for more information on the SPIROMICS study.

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CYSTIC FIBROSIS STUDIES

1. 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 1-866-2-INHALE for more information on the CADET study.

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