Asthma Clinical Trials

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.

Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma ("VIDA")

Purpose

The purpose of the study is to find out if taking vitamin D in addition to an asthma controller medication helps to prevent worsening of asthma symptoms and asthma attacks.

Detailed Description

This is a randomized, double-blind parallel group trial that will enroll individuals who have vitamin D insufficiency and asthma with persistent symptoms despite low-dose inhaled corticosteroid. Participants on low-dose inhaled corticosteroid will be randomized to add-on therapy with either placebo or high-dose vitamin D for a 28-week period. During the inhaled corticosteroid-stable phase, participants will remain on low-dose inhaled corticosteroid. During the inhaled corticosteroid-taper phase, participants will taper their inhaled corticosteroid by 50% at two time-points post-randomization. The investigators will determine if the addition of vitamin D reduces the likelihood of treatment failure when compared to placebo during both the inhaled corticosteroid-stable and inhaled corticosteroid-taper phases of the study. Given the high prevalence of both vitamin D insufficiency and asthma, this trial has high potential to impact daily asthma management.

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

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.

Mucus Study ("MUCGAL")

Purpose

The purpose of this study is to investigate how abnormal mucus forms in diseases of the airways such as asthma and cystic fibrosis.

Detailed Description

The study protocol involves collection of samples of induced sputum from healthy controls and patients with asthma and cystic fibrosis. Induced sputum is sputum that is coughed up when a solution of salty water is inhaled. The study protocol involves multiple visits for collection of the induced sputum - usually the visit number is between 2 and 5 but it can be as high as 10. By examining the biochemical and biophysical properties of the sputum samples from different patient groups and also the effects of drugs and chemicals on the sputum after it is collected, we can infer mechanism of disease that may be helpful in developing drugs to treat abnormal mucus.

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