Trial Outcomes & Findings for Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma (NCT NCT04651777)
NCT ID: NCT04651777
Last Updated: 2025-08-29
Results Overview
Change in VDP
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Day 0 to day 42
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
Completed V1+V2
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28
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
|
3
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Reasons for withdrawal
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=31 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=31 Participants
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Age, Categorical
Between 18 and 65 years
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22 Participants
n=31 Participants
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Age, Categorical
>=65 years
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9 Participants
n=31 Participants
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Age, Continuous
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54 years
STANDARD_DEVIATION 15 • n=31 Participants
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Sex: Female, Male
Female
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24 Participants
n=31 Participants
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Sex: Female, Male
Male
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7 Participants
n=31 Participants
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Region of Enrollment
Canada
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31 participants
n=31 Participants
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BMI
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31 kg/m^2
STANDARD_DEVIATION 7 • n=31 Participants
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Pre-BD FEV1
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2.1 L
STANDARD_DEVIATION 0.7 • n=31 Participants
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Post-BD FEV1
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2.4 L
STANDARD_DEVIATION 0.8 • n=31 Participants
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Pre-BD Percentage of Predicted FEV1
|
72 percentage predicted
STANDARD_DEVIATION 19 • n=31 Participants
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Post-BD Percentage of Predicted FEV1
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81 percentage predicted
STANDARD_DEVIATION 19 • n=31 Participants
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Pre-BD FEV1/FVC
|
65 percentage of FEV1/FVC
STANDARD_DEVIATION 12 • n=31 Participants
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Post-BD FEV1/FVC
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68 percentage of FEV1/FVC
STANDARD_DEVIATION 12 • n=31 Participants
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Pre-BD RV/TLC
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44 percentage
STANDARD_DEVIATION 11 • n=31 Participants
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Post-BD RV/TLC
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37 percentage
STANDARD_DEVIATION 12 • n=31 Participants
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Pre-BD Proximal Airway Resistance at 5 Hz (R5)
|
5.7 cm H2O sec/L
STANDARD_DEVIATION 1.7 • n=31 Participants
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Post-BD Proximal Airway Resistance at 5 Hz (R5)
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4.9 cm H2O sec/L
STANDARD_DEVIATION 1.5 • n=31 Participants
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Pre-BD Proximal Airway Resistance at 19 Hz (R19)
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3.7 cm H2O sec/L
STANDARD_DEVIATION 1.2 • n=31 Participants
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Post-BD Proximal Airway Resistance at 19 Hz (R19)
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3.5 cm H2O sec/L
STANDARD_DEVIATION 1.0 • n=31 Participants
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Pre-BD Proximal Airway Resistance at 5 Hz -19Hz (R5-19)
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2.0 cm H2O sec/L
STANDARD_DEVIATION 1.0 • n=31 Participants
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Post-BD Proximal Airway Resistance at 5 Hz - 19 Hz (R5-19)
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1.4 cm H2O sec/L
STANDARD_DEVIATION 0.9 • n=31 Participants
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ACQ-6
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2.0 units on a scale
STANDARD_DEVIATION 1.0 • n=31 Participants
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AQLQ
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4.5 units on a scale
STANDARD_DEVIATION 1.2 • n=31 Participants
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SGRQ
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49 units
STANDARD_DEVIATION 16 • n=31 Participants
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Pre-BD VDP
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15.5 percentage
STANDARD_DEVIATION 12.9 • n=31 Participants
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Post-BD VDP
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10.7 percentage
STANDARD_DEVIATION 10.5 • n=31 Participants
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PRIMARY outcome
Timeframe: Day 0 to day 42Population: One participant did not complete imaging due to non-MR compatible pacemaker. One participant experienced claustrophobia and could not complete a scan at visit 2. Two participants' scans had technical errors which prevented VDP calculation.
Change in VDP
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=24 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily
|
5 ventilation defect percent
Standard Deviation 12
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SECONDARY outcome
Timeframe: Baseline and Day 42Indicator of pulmonary function
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Forced Expiration Volume in One Second
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0.178 L
Standard Deviation 0.516
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SECONDARY outcome
Timeframe: Baseline and Day 42Indicator of pulmonary function
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Forced Vital Capacity
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0.004 L
Standard Deviation 0.634
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SECONDARY outcome
Timeframe: Baseline and Day 42Indicator of pulmonary function
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Residual Volume
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0.084 L
Standard Deviation 1.88
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SECONDARY outcome
Timeframe: Baseline and Day 42Indicator of pulmonary function
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Total Lung Capacity
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0.385 L
Standard Deviation 2.253
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SECONDARY outcome
Timeframe: Baseline and Day 42Indicator of pulmonary function and inflammation
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline in Proximal Airway Reactance at 5 Hz (R5), 19 Hz (R19), and 5 Hz - 19 Hz (R5-19)
R5
|
-1.1 cm H2O sec/L
Standard Deviation 1.187
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Change From Baseline in Proximal Airway Reactance at 5 Hz (R5), 19 Hz (R19), and 5 Hz - 19 Hz (R5-19)
R19
|
-0.36 cm H2O sec/L
Standard Deviation 0.681
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Change From Baseline in Proximal Airway Reactance at 5 Hz (R5), 19 Hz (R19), and 5 Hz - 19 Hz (R5-19)
R5-19
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-0.737 cm H2O sec/L
Standard Deviation 0.724
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SECONDARY outcome
Timeframe: Baseline and Day 42Lung clearance index is the number of breaths it takes until the exhaled nitrogen concentration is \<2.5% of the concentration at the start of the test. It is an indicator of pulmonary function. A lower value is considered better as it indicates it takes a lower number of breaths for the nitrogen to exit the lungs.
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline Lung Clearance Index
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-0.814 number of breaths
Standard Deviation 4.045
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SECONDARY outcome
Timeframe: Baseline and Day 42Asthma Control Questionnaire (ACQ-6) is used to evaluate asthma control. The ACQ-6 is scored from 0 to 6, with higher scores indicating more severely uncontrolled asthma.
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline in Asthma Control
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-0.654 score on a scale
Standard Deviation 1.333
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SECONDARY outcome
Timeframe: Baseline and Day 42Asthma Quality of Life Questionnaire with Standardised Activities (AQLQ(S)) evaluates asthma-related quality of life. The AQLQ(S) is scored from 1-7, with lower scores indicating more severe impairment.
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline in Asthma-related Quality of Life
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0.862 score on a scale
Standard Deviation 1.431
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SECONDARY outcome
Timeframe: Baseline and Day 42The St. George's Respiratory Questionnaire (SGRQ) is a 2-part questionnaire with a score of 0-100, with higher numbers indicating more limitations.
Outcome measures
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=28 Participants
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Change From Baseline in Daily Life and Perceived Well-being Using the SGRQ.
|
-12 score on a scale
Standard Deviation 21
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Adverse Events
Participants With Poorly Controlled Moderate to Severe Asthma
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Poorly Controlled Moderate to Severe Asthma
n=31 participants at risk
Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
FF/UMEC/VI: 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.
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|---|---|
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Infections and infestations
Chest Infection
|
16.1%
5/31 • 9 Months
|
|
Infections and infestations
COVID-19 Infection
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6.5%
2/31 • 9 Months
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|
Nervous system disorders
Light-headedness During Breath-hold
|
6.5%
2/31 • 9 Months
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General disorders
Dry Mouth
|
3.2%
1/31 • 9 Months
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|
Gastrointestinal disorders
Gastroenteritis
|
3.2%
1/31 • 9 Months
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Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
4/31 • 9 Months
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Respiratory, thoracic and mediastinal disorders
Increased Nocturnal Awakening
|
3.2%
1/31 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Mucous/Wheezing
|
3.2%
1/31 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Rib Fracture
|
3.2%
1/31 • 9 Months
|
|
Gastrointestinal disorders
Increased Appetite
|
3.2%
1/31 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
3.2%
1/31 • 9 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place