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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00621582
• Lead Sponsor: Boehringer Ingelheim

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:

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Results First Submitted: 2010-02-09
• Results First Submitted QC: 2010-05-19
• Results First Posted: 2010-06-15
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4918

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)	0 weeks (Visit 1) and 8 weeks (Visit 3)	The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).; Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks)
Patient Tolerability Assessment at Visit 3	8 weeks (Visit 3)	Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"

Secondary Outcome Measures

Name	Time	Method
Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)	2 weeks (Visit 2 and 8 weeks (Visit 3)	The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score ""good"" and ""excellent"" at visit 2 (2 weeks) and visit 3 (8 weeks)
Physician Tolerability Assessment at Visit 3	8 weeks (Visit 3)	The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)