Vahelva Respimat Regulatory Post-marketing Surveillance in Korean Patients With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination)

Study type: Observational

Funder types: Industry

Identifiers

NCT02864407

1237.60

Details and patient eligibility

About

To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with COPD in a routine clinical practice setting

Full description

Study Design:

regulatory PMS study

Enrollment: 3,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have been started on Vahelva Respimat in accordance with the approved label in Korea
• Age >= 18 years at enrolment
• Patients who have signed on the data release consent form

Exclusion criteria

• Patients with hypersensitivity to Vahelva Respimat or to any of the excipients.
• Patients with a history of hypersensitivity to atropine or its derivatives(e.g. ipratropium, oxitropium, glycopyrronium, clidinium, umeclidinium)
• Patients with asthma
• Current participation in other clinical trials

Trial design

3,223 participants in 1 patient group

Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination)

Description:

Korean patients with COPD who are newly prescribed with Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination).

Treatment:

Drug: Vahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination)