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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621582
• Other study ID #: 205.373
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: October 14, 2014
• Start date: May 2006

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:
• Study type: Observational

Clinical Trial 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.

Description:

Study Design:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4918
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)	0 weeks (Visit 1) and 8 weeks (Visit 3)	No
Primary	Patient Tolerability Assessment at Visit 3	Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"	8 weeks (Visit 3)	Yes
Secondary	Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)	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)	2 weeks (Visit 2 and 8 weeks (Visit 3)	No
Secondary	Physician Tolerability Assessment at Visit 3	The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)	8 weeks (Visit 3)	Yes