Skip to main content
OpenTrials
Completed

NCT Number: NCT00274547

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

Tiotropium

Drug

Primary outcomes

  1. Percentage of patients experiencing an exacerbation

    Time frame: 6 months

  2. Percentage of patients hospitalized for a COPD exacerbation

    Time frame: 6 months

Secondary outcomes

  1. Time to first COPD exacerbation

    Time frame: 6 months

  2. Time to first hospitalization associated with an COPD exacerbation

    Time frame: 6 months

  3. Total number of days of corticosteroids for an COPD exacerbation

    Time frame: 6 months

  4. Total number of antibiotics for an COPD exacerbation

    Time frame: 6 months

  5. Number of unscheduled out-patient visits

    Time frame: 6 months

  6. Total number of hospital admissions and total hospital days

    Time frame: 6 months

  7. Trough post-dose FEV1 and FVC

    Time frame: after 3 and 6 months

  8. 90 minute post-dose FEV1 and FVC

    Time frame: after 3 and 6 months

  9. Occurrence of serious adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2003
First posted
Jan 11, 2006
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.