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

Boehringer Ingelheim1,829 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,829

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

TiotropiumDRUG

Locations (26)

Outcomes

Primary Outcomes

Percentage of patients experiencing an exacerbation

Time frame: 6 months

Percentage of patients hospitalized for a COPD exacerbation

Time frame: 6 months

Secondary Outcomes

Time to first COPD exacerbation

Time frame: 6 months

Time to first hospitalization associated with an COPD exacerbation

Time frame: 6 months

Total number of days of corticosteroids for an COPD exacerbation

Time frame: 6 months

Total number of antibiotics for an COPD exacerbation

Time frame: 6 months

Number of unscheduled out-patient visits

Time frame: 6 months

Total number of hospital admissions and total hospital days

Time frame: 6 months

Trough post-dose FEV1 and FVC

Time frame: after 3 and 6 months

90 minute post-dose FEV1 and FVC

Time frame: after 3 and 6 months

Occurrence of serious adverse events

Time frame: 6 months

Data from ClinicalTrials.gov

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