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]

Trial Profile

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]

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top