A Phase 1 interventional study of Tauroursodeoxycholic Acid in Asthma, sponsored by University of Vermont. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by University of Vermont · Phase 1, Interventional, and Treatment
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.
Study Design: This study will be a Phase 1, pre-post intervention trial in patients with asthma who will be treated with TUDCA 1750 mg per day for 12 weeks. The investigators have obtained TUDCA from Bruschettini (http://www.bruschettini.com), which is an authorized Italian pharmaceutical company that can provide validation of the drug's manufacture and purity. Bruschettini markets TUDCA under the brand name Taurolite. The investigators have received an IND from the FDA for use of Taurolite in this study (see document).
Protocol: All participants will undergo an initial screening visit by telephone to determine. Participants will then present to the Vermont Lung Center in Colchester for 2 study visits, during which the following testing and information will be obtained:
Visit 1 (Baseline)
The participant will also receive a daily diary to use to record daily symptoms of asthma and any side effects, as well as compliance with taking the medication.
Visit 2 (Week 4) and Visit 3 (Week 8)
Telephone Calls (Weeks 2,6,10) The investigators will call participants every 2 weeks in between study visits to assess tolerability and remind participants to complete their daily diaries. The investigators will use a standardized questionnaire for study coordinators to use during each assessment by telephone to determine whether there have been any adverse events.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 11 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
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Exclusion Criteria:
TUDCA 1750 mg daily for 12 weeks
Drug: Tauroursodeoxycholic Acid
Naturally occurirng bile acid
Also known as: Taurolite
AST
Liver toxicity by AST
Time frame: 12 weeks
ALT
Liver toxicity by ALT
Time frame: 12 weeks
alkaline phosphatase
Liver toxicity by alkaline phosphatase
Time frame: 12 weeks
total bilirubin
Liver toxicity by total bilirubin
Time frame: 12 weeks
BUN
Renal toxicity by BUN
Time frame: 12 weeks
creatinine
renal function by creatinine
Time frame: 12 weeks
CBC
Hematology toxicity by CBC
Time frame: 12 weeks
total cholesterol
Lipid toxicity by total cholesterol
Time frame: 12 weeks
LDL
Lipid toxicity by LDL
Time frame: 12 weeks
HDL
Lipid toxicity by HDL
Time frame: 12 weeks
triglycerides
Lipid toxicity by triglycerides
Time frame: 12 weeks
symptom diary
symptoms and side effects
Time frame: 12 weeks
ACT score
Asthma control by ACT score
Time frame: 12 weeks
spirometry
Lung function by spirometry
Time frame: 12 weeks
forced oscillation
Lung function by spirometry
Time frame: 12 weeks
FeNO
Airway eosinophilic inflammation by FeNO
Time frame: 12 weeks
peripheral eosinophil count
Allergic inflammation by peripheral eosinophil count
Time frame: 12 weeks
IgE
Allergic inflammation by peripheral eosinophil count
Time frame: 12 weeks
HSPA5 (GRP78)
Markers of ER stress in nasal epithelium - HSPA5 (GRP78)
Time frame: 12 weeks
DDIT (CHOP)
Markers of ER stress in nasal epithelium - DDIT (CHOP)
Time frame: 12 weeks
PDIA3
Markers of ER stress in nasal epithelium - PDIA3
Time frame: 12 weeks
XBP1
Markers of ER stress in nasal epithelium - XBP1
Time frame: 12 weeks
serum periostin
Allergic inflammation by serum periostin
Time frame: 12 weeks
CCL-20
Allergic inflammation by CCL-20
Time frame: 12 weeks
IL-4
Allergic inflammation by IL-4
Time frame: 12 weeks
IL-5
Allergic inflammation by IL-5
Time frame: 12 weeks
IL-13
Allergic inflammation by IL-13
Time frame: 12 weeks
IL-17A
Allergic inflammation by IL-17A
Time frame: 12 weeks
Plan to share: Undecided
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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