Clinical Trials Directory

Trials / Completed

CompletedNCT02864407

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

A Regulatory Required Non Interventional Study to Monitor the Safety and Effectiveness of Once Daily Treatment of Orally Inhaled Vahelva Respimat (Tiotropium + Olodaterol Fixed Dose Combination 2.5µg/2.5µg Per Puff (2 Puffs Comprise One Medicinal Dose)) for Korean Patients With COPD (Chronic Obstructive Pulmonary Disease)

Status
Completed
Phase
Study type
Observational
Enrollment
3,223 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

Study Design: regulatory PMS study

Conditions

Interventions

TypeNameDescription
DRUGVahelva® Respimat® (Tiotropium + Olodaterol fixed dose combination)The recommended dose for adults is 5 microgram Tiotropium and 5 microgram Olodaterol given as two puffs from the Respimat® inhaler once daily at the same time of the day.

Timeline

Start date
2016-12-19
Primary completion
2021-01-20
Completion
2021-01-20
First posted
2016-08-12
Last updated
2022-03-28
Results posted
2022-01-19

Locations

1 site across 1 country: South Korea

Regulatory

Source: ClinicalTrials.gov record NCT02864407. Inclusion in this directory is not an endorsement.