Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Industry

Identifiers

NCT00621582

205.373

Details and patient eligibility

About

The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.

Full description

Study Design:

Enrollment: 4,918 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.

Patients over 40 years old

Exclusion criteria

Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma

• Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
• Patient with known moderate to severe renal impairment (i.e.,creatinin clearance<=50ml/min)
• Pregnant or nursing women
• Patient with any significant disease other than COPD which would exclude him/her from participating in the study
• Patients with any conditions listed in [special precautions], [drug interactions], and [contraindication] of Spiriva® China package insert
• Patients with signed informed consent of any other study