Tiotropium / Respimat One-Year Study

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Placebo; Drug: Tiotropium Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168831

205.255

Details and patient eligibility

About

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

Enrollment: 1,007 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Criteria

• Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,007 participants in 3 patient groups

Tiotropium Respimat 5mcg (Tio R5)

Other group

Treatment:

Drug: Tiotropium Inhalation Solution

Tiotropium Respimat 10mcg (Tio R10)

Other group

Treatment:

Drug: Tiotropium Inhalation Solution

Placebo

Other group

Treatment:

Other: Placebo