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Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tiotropium
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Carl T. Hayden VA Medical Center
  • Southern Arizona VA Health Care System
  • VA Long Beach Healthcare System
  • Boehringer Ingelheim Investigational Site
  • Respiratory Diseases (111A)
  • J. Hillis Miller Health Center
  • Veteran Affairs Medical Center
  • Veterans Affairs Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 4720 I-10 Service Road
  • Boehringer Ingelheim Investigational Site
  • Veteran Affairs Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Bronx VA Medical Center
  • Boehringer Ingelheim Investigational Site
  • Dallas VAMC
  • Veterans Affairs Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Hampton VA Medical Center
  • Hunter Holmes McGuire Medical Center

Outcomes

Primary Outcome Measures

Percentage of patients experiencing an exacerbation
Percentage of patients hospitalized for a COPD exacerbation

Secondary Outcome Measures

Time to first COPD exacerbation
Time to first hospitalization associated with an COPD exacerbation
Total number of days of corticosteroids for an COPD exacerbation
Total number of antibiotics for an COPD exacerbation
Number of unscheduled out-patient visits
Total number of hospital admissions and total hospital days
Trough post-dose FEV1 and FVC
90 minute post-dose FEV1 and FVC
Occurrence of serious adverse events

Full Information

First Posted
January 9, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274547
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1829 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium
Primary Outcome Measure Information:
Title
Percentage of patients experiencing an exacerbation
Time Frame
6 months
Title
Percentage of patients hospitalized for a COPD exacerbation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to first COPD exacerbation
Time Frame
6 months
Title
Time to first hospitalization associated with an COPD exacerbation
Time Frame
6 months
Title
Total number of days of corticosteroids for an COPD exacerbation
Time Frame
6 months
Title
Total number of antibiotics for an COPD exacerbation
Time Frame
6 months
Title
Number of unscheduled out-patient visits
Time Frame
6 months
Title
Total number of hospital admissions and total hospital days
Time Frame
6 months
Title
Trough post-dose FEV1 and FVC
Time Frame
after 3 and 6 months
Title
90 minute post-dose FEV1 and FVC
Time Frame
after 3 and 6 months
Title
Occurrence of serious adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Carl T. Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Respiratory Diseases (111A)
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
J. Hillis Miller Health Center
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Veteran Affairs Medical Center
City
Hines
State/Province
Illinois
Country
United States
Facility Name
Veterans Affairs Medical Center
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
4720 I-10 Service Road
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Veteran Affairs Medical Center
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Bronx VA Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Dallas VAMC
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Hampton VA Medical Center
City
Hampton
State/Province
Virginia
Country
United States
Facility Name
Hunter Holmes McGuire Medical Center
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.266.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.266_literature.pdf
Description
Related Info

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Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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