NCT00274547

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,829

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients experiencing an exacerbation

    6 months

  • Percentage of patients hospitalized for a COPD exacerbation

    6 months

Secondary Outcomes (9)

  • Time to first COPD exacerbation

    6 months

  • Time to first hospitalization associated with an COPD exacerbation

    6 months

  • Total number of days of corticosteroids for an COPD exacerbation

    6 months

  • Total number of antibiotics for an COPD exacerbation

    6 months

  • Number of unscheduled out-patient visits

    6 months

  • +4 more secondary outcomes

Interventions

TiotropiumDRUG

Sponsors & Collaborators

Study Sites (26)

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

Carl T. Hayden VA Medical Center

Phoenix, Arizona, United States

Location

Southern Arizona VA Health Care System

Tuscon, Arizona, United States

Location

VA Long Beach Healthcare System

Long Beach, California, United States

Location

Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Location

Respiratory Diseases (111A)

Bay Pines, Florida, United States

Location

J. Hillis Miller Health Center

Gainesville, Florida, United States

Location

Veteran Affairs Medical Center

Hines, Illinois, United States

Location

Veterans Affairs Medical Center

North Chicago, Illinois, United States

Location

Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

4720 I-10 Service Road

Metairie, Louisiana, United States

Location

Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

Veteran Affairs Medical Center

Minneapolis, Minnesota, United States

Location

Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

Boehringer Ingelheim Investigational Site

Buffalo, New York, United States

Location

Bronx VA Medical Center

New York, New York, United States

Location

Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Location

Dallas VAMC

Dallas, Texas, United States

Location

Veterans Affairs Medical Center

Houston, Texas, United States

Location

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

Hampton VA Medical Center

Hampton, Virginia, United States

Location

Hunter Holmes McGuire Medical Center

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 11, 2006

Study Start

September 1, 2001

Primary Completion

February 1, 2003

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(26)