Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma

NCT03878654 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: UVermont
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (12)

• AST

  Liver toxicity by AST

  12 weeks

• ALT

  Liver toxicity by ALT

  12 weeks

• alkaline phosphatase

  Liver toxicity by alkaline phosphatase

  12 weeks

• total bilirubin

  Liver toxicity by total bilirubin

  12 weeks

• BUN

  Renal toxicity by BUN

  12 weeks

• creatinine

  renal function by creatinine

  12 weeks

• CBC

  Hematology toxicity by CBC

  12 weeks

• total cholesterol

  Lipid toxicity by total cholesterol

  12 weeks

• LDL

  Lipid toxicity by LDL

  12 weeks

• HDL

  Lipid toxicity by HDL

  12 weeks

• triglycerides

  Lipid toxicity by triglycerides

  12 weeks

• symptom diary

  symptoms and side effects

  12 weeks

Secondary Outcomes (16)

• ACT score

  12 weeks

• spirometry

  12 weeks

• forced oscillation

  12 weeks

• FeNO

  12 weeks

• peripheral eosinophil count

  12 weeks

Study Arms (1)

Tauroursodeoxycholic Acid

EXPERIMENTAL

TUDCA 1750 mg daily for 12 weeks

Drug: Tauroursodeoxycholic Acid

Interventions

Tauroursodeoxycholic Acid DRUG

Naturally occurirng bile acid

Also known as: Taurolite

Tauroursodeoxycholic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged 18 and older, with a physician diagnosis of asthma
• Current non-smoker with \< 10 pack-years smoking history and no smoking within the last year
• Stable asthma control over the last 3 months as defined by Asthma Control Test (ACT) ≥ 20 (40)
• Stable asthma medication regimen over the last 3 months
• FEV1 ≥ 70% predicted

You may not qualify if:

• Current smoking or ≥10 pack-years of smoking or any smoking within the last year
• Poor asthma control as defined by ACT\< 20
• Exacerbation of disease within previous 4 weeks
• Recent upper respiratory infection within last 4 weeks
• Acute or chronic rhinosinusitis
• Use of chronic nasal corticosteroids, or any use of nasal corticosteroids during the study
• Concomitant heart, lung or GI disease (liver, peptic ulcer) that would potentially jeopardize the safety of the participant or interfere with interpretation of the results

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Related Publications (1)

• Siddesha JM, Nakada EM, Mihavics BR, Hoffman SM, Rattu GK, Chamberlain N, Cahoon JM, Lahue KG, Daphtary N, Aliyeva M, Chapman DG, Desai DH, Poynter ME, Anathy V. Effect of a chemical chaperone, tauroursodeoxycholic acid, on HDM-induced allergic airway disease. Am J Physiol Lung Cell Mol Physiol. 2016 Jun 1;310(11):L1243-59. doi: 10.1152/ajplung.00396.2015. Epub 2016 May 6.

  PMID: 27154200 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Kaminsky, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: March 18, 2019
• Study Start: January 10, 2019
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

US (1)