Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) in the Veterans Affairs (VA) Setting
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel, Group Trial Assessing the Proportion of Patients Experiencing Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a VA Setting|
- The co-primary endpoints were the proportion of patients experiencing an exacerbation of COPD and the proportion of patients hospitalized for a COPD exacerbation during the six month treatment period.
- Number of exacerbations and related hospitalizations, time to first exacerbation and related hospitalization, mean # of days of antibiotics/steroids for exacerbations, # of unscheduled visits for exacerbation, pulmonary function at study visits.
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||December 2003|
Show 26 Study Locations
|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Pharmaceuticals|