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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium

Study type: Observational

Funder types: Industry

Identifiers

NCT00624377

205.399

Details and patient eligibility

About

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.

Enrollment: 2,031 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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®.

Trial design

2,031 participants in 1 patient group

COPD patients

Treatment:

Drug: Tiotropium