CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
tiotropium + olodaterol +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01559116
NCT01559116Phase 3Completed
CompareCT.gov

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 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]

Boehringer Ingelheim·interventional·Posted Mar 21, 2012·Updated Jul 16, 2015

In Brief

A Phase 3 clinical trial evaluating tiotropium + olodaterol, tiotropium, and 3 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 219 participants across 29 sites in 7 countries.

Detailed Summary

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesBelgium, Canada, Denmark, Germany, Hungary, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago

Interventions

tiotropium + olodateroldrug

low dose + one dose only

tiotropiumdrug

low dose

olodateroldrug

one dose only

tiotropiumdrug

high dose

tiotropium + olodateroldrug

low dose + one dose only

Placebodrug

placebo matching tiotropium+olodaterol FDC

Respimatdevice

Respimat inhaler