CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 469 enrolled
Drug / intervention
Spiolto® Respimat® +1 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/NCT03954132
NCT03954132N/ACompleted
CompareCT.gov

EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice

Boehringer Ingelheim·observational·Posted May 17, 2019·Updated Apr 24, 2024

In Brief

An observational study evaluating Spiolto® Respimat® and Triple-Therapy (LAMA/LABA/ICS) for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 469 participants across 75 sites.

Detailed Summary

Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 17, 2019
Enrollment StartJun 7, 2019
Primary CompletionJun 30, 2021
Study CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.1 years ago

Interventions

Spiolto® Respimat®drug

Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.

Triple-Therapy (LAMA/LABA/ICS)drug

Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.