Tiotropium / Respimat One Year Study in COPD.

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Respimat; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387088

2006-001009-27

205.372

Details and patient eligibility

About

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Enrollment: 3,991 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history > 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion criteria

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.

Trial design

3,991 participants in 2 patient groups

Tiotropium

Other group

Description:

Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Treatment:

Drug: Tiotropium

Placebo

Other group

Description:

Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Treatment:

Device: Respimat