Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

NCT ID: NCT00624377

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2031 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31

Brief Summary

The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

Tiotropium

Intervention Type: DRUG

Tiotropium 18 mcg HandiHaler once daily

Interventions

Tiotropium

Tiotropium 18 mcg HandiHaler once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).

2. Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.

3. Tiotropium bromide naïve patients.

4. Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.

Exclusion Criteria

1. Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).

2. Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Chan Wha, , Taiwan

Boehringer Ingelheim Investigational Site

Chiayi City, , Taiwan

Boehringer Ingelheim Investigational Site

Hwa Lian, , Taiwan

Boehringer Ingelheim Investigational Site 1

Kaohsiung City, , Taiwan

Boehringer Ingelheim Investigational Site 2

Kaohsiung City, , Taiwan

Boehringer Ingelheim Investigational Site 3

Kaohsiung City, , Taiwan

Boehringer Ingelheim Investigational Site 1

Taichung, , Taiwan

Boehringer Ingelheim Investigational Site 2

Taichung, , Taiwan

Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Boehringer Ingelheim Investigational Site 1

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site 2

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site 3

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site 4

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site 5

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site 6

Taipiei, , Taiwan

Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

205.399

Identifier Type: -

Identifier Source: org_study_id