Finding studies
Finding studies
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Lead
University of Vermont
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) * Demographics: age, sex, height, weight * Concomitant medical problems and medications * Asthma control by ACT * Lung function testing: spirometry (FEV1, FVC, FEV1/FVC) (43), forced oscillation technique (FOT) (R5, R20, X5, AX, Fres) (44) * Fraction of exhaled nitric oxide (FeNO) as a general measure of eosinophilic inflammation(45) * Blood sample collection for routine chemistries (10 cc), and for analysis of serum markers of inflammation (10 cc). * Nasal brushing for collection of epithelial cells for analysis of serum markers of ER stress and UPR The participant will then receive a supply of medication, TUDCA 250 mg, to be taken 500 mg with breakfast, 500 mg with lunch, 750 mg with dinner, daily, for 12 weeks. 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) * Review of diary for side effects, adverse events * Asthma control by ACT, spirometry, FeNO * Blood for routine chemistries as part of ongoing safety monitoring Visit 4 (Week 12) All testing as listed for Visit 1 will be repeated, with collection of any remaining drug and all diary data. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
