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

NCT ID: NCT00621582

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4918 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31

Brief Summary

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.

Detailed Description

Study Design:

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Other Identifiers

205.373

Identifier Type: -

Identifier Source: org_study_id