CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 31 enrolled
Drug / intervention
FF/UMEC/VIdrug
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/NCT04651777
NCT04651777Phase 3Active

Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma

Dr. Grace Parraga·interventional·Posted Dec 3, 2020·Updated Aug 29, 2025

In Brief

A Phase 3 clinical trial evaluating FF/UMEC/VI for Asthma. Active but no longer recruiting, targeting 31 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effectiveness of treatment with triple therapy an inhaler that contains three types of asthma medications, on participants with poorly controlled asthma. The triple therapy medication contains fluticasone furoate, an inhaled corticosteroid (ICS) which reduces inflammation in the lungs; umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), a medication which helps open up the airways; and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA) which also helps open up airways, delivered in a single daily inhalation via an Ellipta inhaler. The Investigators will evaluate lung structure and function using magnetic resonance imaging (MRI). Participants will inhale xenon gas before an MRI image of their lungs is taken. Using a special technique xenon is visible in MRI images, so this lets us see how air spreads in the lungs. In healthy lungs, the gas fills the lungs evenly, but in unhealthy lungs, the gas may fill the lungs unevenly and they will appear patchy. The patchy areas are called ventilation defects. A CT of the chest will be done to assess the structure of the lungs. The Investigators will also be using lung function testing and questionnaires to compare them to MRI ventilation defect measurements.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada
CollaboratorsGlaxoSmithKline

Timeline

Phase 3ActiveOverdue
202120222023202420252026
First PostedDec 3, 2020
Enrollment StartAug 8, 2022
Primary CompletionAug 25, 2023
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.6 years ago

Interventions

FF/UMEC/VIdrug

The investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol. The drug is delivered in an Ellipta inhaler in a single dose once daily.