This is a chronological listing of grants held by this department, with the most recent listed first. New grants appear in this list weekly and contribute related to the department's Research Profile. The source of grants for this application comes directly from your institution.
2009-MUC-01 An open-label, 2-way cross-over placebo-controlled, radio-labeled
William Bennett; Ashley Henderson; Aline Kala5/8/2009 - 5/7/2012
|Sponsoring Organization:||Industry Sponsor|
|Awarding Organization Is:||University of North Carolina at Chapel Hill|
Guaifenesin (Mucinex® 1200 mg), the only FDA-approved non-prescription expectorant, loosens and thins lower respiratory tract secretions, and makes coughs more productive. The mechanism or time course by which guaifenisin may help clear secretions from the lungs is unclear, however. Early studies to assess the effect of guafenisin on mucociliary or cough clearance showed conflicting results. This Phase I, open-label, randomized, 2-way crossover, placebo-controlled radio-labeled tracer study is designed to evaluate the acute effect of a single dose of Mucinex® 1200 mg on mucociliary and cough clearance from the human lung in healthy volunteers when compared to placebo. The study will consist of a screening period (Day -21 to Day -2), and two treatment periods. Each treatment period will be separated by at least 7 days and no longer than 3 weeks. Up to 8 subjects will receive a single dose of Mucinex 1200 mg tablet and placebo. Mucociliary and cough clearance will be measured by the use of gamma camera acquisition and analysis of the rate of removal from the lung of inhaled, deposited radioactive tracer particles following oral administration of active or placebo treatment. In addition blood samples will be collected during each of the two treatment periods to assess the pharmacokinetics of the drug in the body. The findings of this study should provide useful information on the efficacy and mechanism of action for Mucinex to improve clearance of secretions from the lungs.