Clinical trial NCT00274547: Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an 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 Veterans Affairs Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 1829
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.



Primary outcomes:
measure: Percentage of patients experiencing an exacerbation
timeFrame: 6 months
measure: Percentage of patients hospitalized for a COPD exacerbation
timeFrame: 6 months
Secondary outcomes:
measure: Time to first COPD exacerbation
timeFrame: 6 months
measure: Time to first hospitalization associated with an COPD exacerbation
timeFrame: 6 months
measure: Total number of days of corticosteroids for an COPD exacerbation
timeFrame: 6 months
measure: Total number of antibiotics for an COPD exacerbation
timeFrame: 6 months
measure: Number of unscheduled out-patient visits
timeFrame: 6 months
measure: Total number of hospital admissions and total hospital days
timeFrame: 6 months
measure: Trough post-dose FEV1 and FVC
timeFrame: after 3 and 6 months
measure: 90 minute post-dose FEV1 and FVC
timeFrame: after 3 and 6 months
measure: Occurrence of serious adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Tuscon
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Palo Alto
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Bay Pines
country: United States
facility: Respiratory Diseases (111A)
state: Florida
city: Gainesville
country: United States
facility: J. Hillis Miller Health Center
state: Florida
city: Hines
country: United States
facility: Veteran Affairs Medical Center
state: Illinois
city: North Chicago
country: United States
facility: Veterans Affairs Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: 4720 I-10 Service Road
state: Louisiana
city: Boston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Veteran Affairs Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nebraska
city: Reno
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nevada
city: Buffalo
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: Bronx VA Medical Center
state: New York
city: Durham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Dallas
country: United States
facility: Dallas VAMC
state: Texas
city: Houston
country: United States
facility: Veterans Affairs Medical Center
state: Texas
city: San Antonio
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Hampton
country: United States
facility: Hampton VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Medical Center
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: