Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma
Status:
Terminated
Trial end date:
2019-09-11
Target enrollment:
Participant gender:
Summary
Asthma is a chronic lung disease that affects millions of people worldwide, including both
children and adults. The cause of asthma is not known, but asthma is strongly associated with
inflammation of the airways, often caused by allergies. In order to control this
inflammation, most people with asthma are treated with inhaled medications that contain
steroids. These medications do a good job of helping most people with asthma feel better.
However, these medications are expensive, have side effects, and do not control symptoms in
all people with asthma. Recently basic science research colleagues have shown that
inflammation due to allergies can be reduced in experimental animals by a naturally occurring
bile acid. Bile acids are chemicals made in the liver that are involved in maintaining
healthy digestion of fat. Since bile acids are made by our bodies, they have become popular
as over the counter supplements that are thought to be important in promoting a healthy liver
and metabolism. Interestingly, other research has shown that bile acids may help patients
with neurological disease and diabetes.
Given all of this information, the investigators propose that a specific bile acid called
tauroursodeoxycholic acid (TUDCA) may be helpful in patients with asthma. Before studying
this in a clinical trial, the current study is designed to demonstrate that people with
asthma can take TUDCA safely and that it doesn't hurt their asthma. The study will involve
inviting 12 patients with mild asthma to take TUDCA daily for 12 weeks. During this time the
investigators will closely monitor them for any side effects and check their blood and
breathing capacity for any signs of detrimental effects. In addition, the investigators will
collect cells that line the nose, which are thought to be similar to cells in the airways of
the lungs, to see if TUDCA is having any beneficial effects on inflammation. In order to
ensure the use of high quality TUDCA, which may or may not be true of over the counter
supplements, the investigators have asked the company that is supplying TUDCA for the studies
mentioned previously involving neurological disease and diabetes to supply the drug; the
brand name is Taurolite. In addition, even though TUDCA is available over the counter, in
order to use it for research, the FDA has to approve this use. Accordingly, the investigators
have applied for and received permission (IND) from the FDA to use Taurolite for this study.