Trial Profile

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 of Trial: Phase IV

Latest Information Update: 29 Mar 2022

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At a glance

Drugs Olodaterol/tiotropium bromide (Primary) ; Olodaterol/tiotropium bromide (Primary)
Indications Chronic obstructive pulmonary disease
Focus Therapeutic Use
Sponsors Boehringer Ingelheim

24 Aug 2021 Status changed from recruiting to completed.
20 Apr 2017 Primary endpoint has been changed from Outcomes pertaining to safety will be presented as incidence rates of adverse events to Change from baseline in (pre-dose) FEV1. hence trial focus also changed
20 Apr 2017 Planned End Date changed from 1 May 2021 to 30 Aug 2021.

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