Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 mcg, 5/5 mcg), Tiotropium (2.5 mcg, 5 mcg) and Olodaterol (5 mcg) (Oral Inhalation, Delivered by the Respimat Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITO]
Phase of Trial: Phase III
Latest Information Update: 22 Jul 2015
At a glance
- Drugs Olodaterol/tiotropium bromide (Primary) ; Olodaterol; Tiotropium bromide
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms VIVACITO
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 19 Aug 2014 The FDA has accepted an NDA for olodaterol/tiotropium for maintenance therapy for COPD based on results from TOnado-1, TOnado-2 and VIVACITO, according to a Boehringer Ingelheim media release.
- 02 Jul 2014 According to a Boehringer Ingelheim media release, results from TOnado 1 and 2 as well as other TOviTO programme data are expected to be reported later in 2014.
- 01 Aug 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History