CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
placebo to tiotropium + olodaterol +3 moredrug
Likely dose
tiotropium+olodaterol 5 mcgfrom 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/NCT02085161
NCT02085161Phase 3Completed

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim·interventional·Posted Mar 12, 2014·Updated Jan 6, 2017

In Brief

A Phase 3 clinical trial evaluating placebo to tiotropium + olodaterol, tiotropium+olodaterol, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 304 participants across 34 sites in 11 countries.

Detailed Summary

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, Denmark, Germany, New Zealand, Poland, Portugal, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 12, 2014
Enrollment StartMar 1, 2014
Primary CompletionAug 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.3 years ago

Interventions

placebo to tiotropium + olodateroldrug

comparator

tiotropium+olodateroldrug

tiotropium 5 mcg once daily

tiotropium +olodateroldrug

olodaterol 5 mcg once daily fixed dose combination

tiotropiumdrug

tiotropium 5 mcg once daily fixed dose combination