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)
Phase of Trial: Phase IV
Latest Information Update: 25 Apr 2017
At a glance
- Drugs Olodaterol/tiotropium bromide (Primary)
- Indications Chronic obstructive pulmonary disease
- Focus Therapeutic Use
- Sponsors Boehringer Ingelheim
- 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.
- 20 Apr 2017 Planned primary completion date changed from 1 May 2021 to 30 Aug 2021.