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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274547

Enrollment

1829

Registered

2006-01-11

Start date

2001-09-30

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DRUGTiotropium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Design outcomes

Primary

Measure	Time frame
Percentage of patients experiencing an exacerbation	6 months
Percentage of patients hospitalized for a COPD exacerbation	6 months

Secondary

Measure	Time frame
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
Time to first COPD exacerbation	6 months
Trough post-dose FEV1 and FVC	after 3 and 6 months
90 minute post-dose FEV1 and FVC	after 3 and 6 months
Occurrence of serious adverse events	6 months
Total number of hospital admissions and total hospital days	6 months
Time to first hospitalization associated with an COPD exacerbation	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026