A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 1)
Protocol Description
The objective of the phase IV study is to investigate the safety and efficacy of treatment with tiotropium bromide (Spariva) in COPD patients recovering from hospitalization for an acute exacerbation compared to placebo. A history of prior hospitalization for COPD has been shown to be a risk factor for re-hospitalization. The goal of this study is to see if taking Spariva can increase the time before re-hospitalization. Spariva has been shown to decrease the frequency and severity of COPD exacerbations but it is unclear if these positive effects will be seen in patients recovering from hospitalization due to an exacerbation.
Patients participating in this study will be randomly assigned in a 1:1 ration to receive Spariva or placebo. Patients participating in the study will receive the study drug (Spariva) as well as rescue medication (albuterol) at no cost. Compensation is also available for time and travel.
Eligibility Criteria
Study participants must be at least 40 years of age, a current or past smoker, and hospitalized due to a COPD exacerbation.
Primary Investigator(s)
Edmundo Rubio, M.D.
Contact Information
Casey Benson
Clinical Research Coordinator
Phone: 540-985-9723
Email: clbenson@carilionclinic.org
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