CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
tiotropium +2 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/NCT02629965
NCT02629965Phase 3Completed

A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim·interventional·Posted Dec 15, 2015·Updated Jun 6, 2019

In Brief

A Phase 3 clinical trial evaluating tiotropium and olodaterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 184 participants across 43 sites.

Detailed Summary

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 15, 2015
Enrollment StartFeb 12, 2016
Primary CompletionMar 24, 2017
Study CompletionApr 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.5 years ago

Interventions

tiotropiumdrug

fixed dose combination

olodateroldrug

fixed dose combination

tiotropiumdrug