CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
hyperpolarized 129Xe gas MRI +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/NCT03324607
NCT03324607Phase 3Completed

Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

Bastiaan Driehuys·interventional·Posted Oct 27, 2017·Updated Jan 19, 2021

In Brief

A Phase 3 clinical trial evaluating hyperpolarized 129Xe gas MRI and Bevespi Aerosphere for COPD. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 27, 2017
Enrollment StartApr 20, 2018
Primary CompletionNov 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.7 years ago

Interventions

hyperpolarized 129Xe gas MRIdrug

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.

Bevespi Aerospheredrug

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.