Trial Outcomes & Findings for Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study (NCT NCT02025205)
NCT ID: NCT02025205
Last Updated: 2019-08-16
Results Overview
Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
At baseline and after 3 months
Results posted on
2019-08-16
Participant Flow
Participant milestones
| Measure |
BLVR With Zephyr Endobronchial Valves
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
50
|
|
Overall Study
COMPLETED
|
40
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
BLVR With Zephyr Endobronchial Valves
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
The number of subjects in the EBV and SoC group analyzed for Pack year smoking history is less than the overall population, due to missing data.
Baseline characteristics by cohort
| Measure |
ELVR With Endobronchial Valves
n=43 Participants
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Endobronchial Valve: Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight
|
67.9 kg
STANDARD_DEVIATION 15.4 • n=43 Participants
|
62.2 kg
STANDARD_DEVIATION 12 • n=50 Participants
|
64.8 kg
STANDARD_DEVIATION 13.9 • n=93 Participants
|
|
BMI
|
23.7 kg/m^2
STANDARD_DEVIATION 4.3 • n=43 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 3.7 • n=50 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 4.0 • n=93 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 6.3 • n=43 Participants
|
63.2 years
STANDARD_DEVIATION 6.0 • n=50 Participants
|
63.7 years
STANDARD_DEVIATION 6.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=43 Participants
|
34 Participants
n=50 Participants
|
57 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=43 Participants
|
16 Participants
n=50 Participants
|
36 Participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=43 Participants
|
14 participants
n=50 Participants
|
23 participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=43 Participants
|
13 participants
n=50 Participants
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=43 Participants
|
23 participants
n=50 Participants
|
49 participants
n=93 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION 10.0 • n=43 Participants
|
165.4 cm
STANDARD_DEVIATION 9.1 • n=50 Participants
|
166.9 cm
STANDARD_DEVIATION 9.6 • n=93 Participants
|
|
Pack Years Smoking History
|
41.5 pack-years
STANDARD_DEVIATION 19.6 • n=41 Participants • The number of subjects in the EBV and SoC group analyzed for Pack year smoking history is less than the overall population, due to missing data.
|
42.5 pack-years
STANDARD_DEVIATION 22.0 • n=48 Participants • The number of subjects in the EBV and SoC group analyzed for Pack year smoking history is less than the overall population, due to missing data.
|
42.0 pack-years
STANDARD_DEVIATION 20.8 • n=89 Participants • The number of subjects in the EBV and SoC group analyzed for Pack year smoking history is less than the overall population, due to missing data.
|
|
Gold stage
Gold Stage III
|
18 Participants
n=43 Participants
|
23 Participants
n=50 Participants
|
41 Participants
n=93 Participants
|
|
Gold stage
Gold Stage IV
|
25 Participants
n=43 Participants
|
27 Participants
n=50 Participants
|
52 Participants
n=93 Participants
|
|
Emphysema score
|
68.0 percent
STANDARD_DEVIATION 7.5 • n=43 Participants
|
65.8 percent
STANDARD_DEVIATION 6.9 • n=50 Participants
|
66.8 percent
STANDARD_DEVIATION 7.3 • n=93 Participants
|
|
Heterogeneity index
|
6.8 units on a scale
STANDARD_DEVIATION 5.7 • n=43 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 6.3 • n=50 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 6.0 • n=93 Participants
|
|
FEV1 (liters)
|
0.8 Liters
STANDARD_DEVIATION 0.2 • n=43 Participants
|
0.8 Liters
STANDARD_DEVIATION 0.2 • n=50 Participants
|
0.8 Liters
STANDARD_DEVIATION 0.2 • n=93 Participants
|
|
FEV1 (% predicted)
|
28.4 % predicted
STANDARD_DEVIATION 6.3 • n=43 Participants
|
30.0 % predicted
STANDARD_DEVIATION 6.6 • n=50 Participants
|
29.3 % predicted
STANDARD_DEVIATION 6.5 • n=93 Participants
|
|
Residual Volume (RV) (Liters)
|
5.7 Liters
STANDARD_DEVIATION 1.1 • n=43 Participants
|
5.2 Liters
STANDARD_DEVIATION 1.2 • n=50 Participants
|
5.5 Liters
STANDARD_DEVIATION 1.2 • n=93 Participants
|
|
Residual Volume (RV) (% predicted)
|
277.3 % predicted
STANDARD_DEVIATION 55.2 • n=43 Participants
|
273.7 % predicted
STANDARD_DEVIATION 63.4 • n=50 Participants
|
275.4 % predicted
STANDARD_DEVIATION 59.4 • n=93 Participants
|
|
Total Lung Capacity (TLC) (Liters)
|
8.4 Liter
STANDARD_DEVIATION 1.6 • n=43 Participants
|
7.6 Liter
STANDARD_DEVIATION 1.4 • n=50 Participants
|
8.0 Liter
STANDARD_DEVIATION 1.5 • n=93 Participants
|
|
Total Lung Capacity (TLC) (% predicted)
|
144.9 % predicted
STANDARD_DEVIATION 21.2 • n=43 Participants
|
144.2 % predicted
STANDARD_DEVIATION 17.6 • n=50 Participants
|
144.6 % predicted
STANDARD_DEVIATION 19.3 • n=93 Participants
|
|
FEV1/FVC (%)
|
36.3 percent
STANDARD_DEVIATION 7.2 • n=43 Participants
|
35.8 percent
STANDARD_DEVIATION 8.6 • n=50 Participants
|
36.0 percent
STANDARD_DEVIATION 7.9 • n=93 Participants
|
|
RV/TLC (%)
|
69.0 percent
STANDARD_DEVIATION 6.3 • n=43 Participants
|
68.2 percent
STANDARD_DEVIATION 7.1 • n=50 Participants
|
68.6 percent
STANDARD_DEVIATION 6.7 • n=93 Participants
|
|
6 Minute Walk Distance (meters)
|
308.0 meters
STANDARD_DEVIATION 91.3 • n=43 Participants
|
328.3 meters
STANDARD_DEVIATION 92.6 • n=50 Participants
|
318.9 meters
STANDARD_DEVIATION 92.1 • n=93 Participants
|
|
SGRQ Total Score
|
63.2 points on a scale
STANDARD_DEVIATION 13.7 • n=41 Participants • The number of subjects in the EBV and SoC group analyzed for SGRQ Total Score is less than the overall population, due to missing data.
|
59.3 points on a scale
STANDARD_DEVIATION 15.6 • n=49 Participants • The number of subjects in the EBV and SoC group analyzed for SGRQ Total Score is less than the overall population, due to missing data.
|
61.1 points on a scale
STANDARD_DEVIATION 14.8 • n=90 Participants • The number of subjects in the EBV and SoC group analyzed for SGRQ Total Score is less than the overall population, due to missing data.
|
|
The COPD Assessment Test (CAT) total score (derived)
|
23.4 points on a scale
STANDARD_DEVIATION 6.8 • n=43 Participants • The number of subjects in the SoC group analyzed for CAT Total Score, derived is less than the overall population, due to missing data.
|
22.8 points on a scale
STANDARD_DEVIATION 6.0 • n=49 Participants • The number of subjects in the SoC group analyzed for CAT Total Score, derived is less than the overall population, due to missing data.
|
23.1 points on a scale
STANDARD_DEVIATION 6.3 • n=92 Participants • The number of subjects in the SoC group analyzed for CAT Total Score, derived is less than the overall population, due to missing data.
|
|
EQ-5D Summary Index
|
0.5 points on a scale
STANDARD_DEVIATION 0.3 • n=39 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D summary index, Europe is less than the overall population, due to missing data.
|
0.6 points on a scale
STANDARD_DEVIATION 0.2 • n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D summary index, Europe is less than the overall population, due to missing data.
|
0.6 points on a scale
STANDARD_DEVIATION 0.3 • n=87 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D summary index, Europe is less than the overall population, due to missing data.
|
|
EQ-5D health state today
|
40.3 score
STANDARD_DEVIATION 14.4 • n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Health State today is less than the overall population, due to missing data.
|
49.3 score
STANDARD_DEVIATION 19.3 • n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Health State today is less than the overall population, due to missing data.
|
45.2 score
STANDARD_DEVIATION 17.7 • n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Health State today is less than the overall population, due to missing data.
|
|
mMRC Dyspnea Grade score
|
2.7 points on a scale
STANDARD_DEVIATION 0.8 • n=42 Participants • The number of subjects in the EBV group analyzed for mMRC breathlessness grade is less than the overall population, due to missing data.
|
2.4 points on a scale
STANDARD_DEVIATION 1.0 • n=50 Participants • The number of subjects in the EBV group analyzed for mMRC breathlessness grade is less than the overall population, due to missing data.
|
2.5 points on a scale
STANDARD_DEVIATION 0.9 • n=92 Participants • The number of subjects in the EBV group analyzed for mMRC breathlessness grade is less than the overall population, due to missing data.
|
|
BODE index
|
5.7 points on a scale
STANDARD_DEVIATION 1.4 • n=42 Participants • The number of subjects in the EBV group analyzed for BODE index is less than the overall population, due to missing data.
|
5.2 points on a scale
STANDARD_DEVIATION 1.7 • n=50 Participants • The number of subjects in the EBV group analyzed for BODE index is less than the overall population, due to missing data.
|
5.4 points on a scale
STANDARD_DEVIATION 1.6 • n=92 Participants • The number of subjects in the EBV group analyzed for BODE index is less than the overall population, due to missing data.
|
|
EQ-5D Mobility
No problems
|
8 Participants
n=41 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
15 Participants
n=48 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
23 Participants
n=89 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
|
EQ-5D Mobility
Some problems
|
32 Participants
n=41 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
33 Participants
n=48 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
65 Participants
n=89 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
|
EQ-5D Mobility
Confined to bed
|
1 Participants
n=41 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
0 Participants
n=48 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
1 Participants
n=89 Participants • The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data.
|
|
EQ-5D Self-Care
No problems
|
13 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
27 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
40 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
|
EQ-5D Self-Care
Some problems
|
25 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
21 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
46 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
|
EQ-5D Self-Care
Unable
|
3 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
0 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
3 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data.
|
|
EQ-5D usual activities
No problems
|
2 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
5 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
7 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
|
EQ-5D usual activities
Some problems
|
32 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
32 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
64 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
|
EQ-5D usual activities
Unable
|
7 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
11 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
18 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data.
|
|
EQ-5D Pain/Discomfort
No
|
16 Participants
n=39 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
28 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
44 Participants
n=87 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
|
EQ-5D Pain/Discomfort
Moderate
|
20 Participants
n=39 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
16 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
36 Participants
n=87 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
|
EQ-5D Pain/Discomfort
Extreme
|
3 Participants
n=39 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
4 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
7 Participants
n=87 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data.
|
|
EQ-5D Anxiety/Depression
No
|
16 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
22 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
38 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
|
EQ-5D Anxiety/Depression
Moderate
|
16 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
24 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
40 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
|
EQ-5D Anxiety/Depression
Extreme
|
9 Participants
n=41 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
2 Participants
n=48 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
11 Participants
n=89 Participants • The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data.
|
PRIMARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
|
13.7 percent change
Standard Deviation 28.2
|
-3.2 percent change
Standard Deviation 13
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsTarget Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=36 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in Target Lobe Volume for EBV Group (ITT Population)
|
1195 mL
Standard Deviation 683.2
|
—
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsTarget Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=36 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change in Target Lobe Volume for EBV Group (ITT Population)
|
64.9 Percent change
Standard Deviation 32.5
|
—
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=36 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months
Yes
|
32 Participants
|
—
|
|
Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months
No
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months
|
0.1 liters
Standard Deviation 0.2
|
-0.02 liters
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months
|
3.4 Percent predicted
Standard Deviation 6.5
|
-1.3 Percent predicted
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in Residual Volume (RV) at 3 Months
|
-0.4 liters
Standard Deviation 0.9
|
0.1 liters
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change in Residual Volume (RV) at 3 Months
|
-6.7 Percent change
Standard Deviation 13.6
|
2.7 Percent change
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Predicted Change in Residual Volume at 3 Months
|
-21.1 Percent change
Standard Deviation 47.6
|
-0.3 Percent change
Standard Deviation 53.6
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=42 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in Six-Minute Walk Distance at 3 Months
|
22.6 meters
Standard Deviation 66.6
|
-17.3 meters
Standard Deviation 52.8
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=42 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change in Six-Minute Walk Distance at 3 Months
|
10.6 Percent change
Standard Deviation 26.5
|
-3.9 Percent change
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=37 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=48 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in the SGRQ Total Score From Baseline to 3 Months
|
-8.6 points on a scale
Standard Deviation 11.3
|
1.0 points on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=37 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=48 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months
|
-14.8 percent change
Standard Deviation 19.5
|
3.9 percent change
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=41 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months
|
-0.4 points on a scale
Standard Deviation 1.0
|
0.2 points on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=41 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=49 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months
|
-11.0 Percent change
Standard Deviation 40.0
|
14.3 Percent change
Standard Deviation 59.3
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group. The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=42 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=49 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in the CAT Total Score From Baseline to 3 Months
|
-1.5 points on a scale
Standard Deviation 5.6
|
-0.7 points on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=42 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=49 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change (%) in CAT Total Score From Baseline to 3 Months
|
-4.9 percent change
Standard Deviation 30.2
|
-0.9 percent change
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group. EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=39 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=48 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months
|
0.1 points on a scale
Standard Deviation 0.2
|
0.01 points on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=39 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=48 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months
|
32.7 percent change
Standard Deviation 70.1
|
26.2 percent change
Standard Deviation 115.0
|
SECONDARY outcome
Timeframe: At baseline and after 3 monthsPopulation: ITT population
Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome.
Outcome measures
| Measure |
BLVR With Zephyr Endobronchial Valves
n=41 Participants
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=48 Participants
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months
|
12.7 points on a scale
Standard Deviation 17.7
|
-0.4 points on a scale
Standard Deviation 17.6
|
Adverse Events
BLVR With Zephyr Endobronchial Valves
Serious events: 28 serious events
Other events: 30 other events
Deaths: 0 deaths
Standard of Care
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 participants at risk
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 participants at risk
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
30.2%
13/43 • Number of events 19
|
24.0%
12/50 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Diagnostic bronchoscopy
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.0%
3/43 • Number of events 3
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
25.6%
11/43 • Number of events 12
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/43
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43
|
4.0%
2/50 • Number of events 2
|
Other adverse events
| Measure |
BLVR With Zephyr Endobronchial Valves
n=43 participants at risk
Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves
Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve
|
Standard of Care
n=50 participants at risk
Patients will receive optimal drug therapy and medical management according to clinical practice.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
3/43 • Number of events 3
|
0.00%
0/50
|
|
Nervous system disorders
Insomnia
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Cardiac disorders
Tachycardia
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 3
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
32.6%
14/43 • Number of events 25
|
20.0%
10/50 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
14.0%
6/43 • Number of events 9
|
12.0%
6/50 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
6/43 • Number of events 6
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Mucus production
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
3/43 • Number of events 3
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granulations
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Infections and infestations
Pulmonary infection
|
7.0%
3/43 • Number of events 4
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary shunt
|
4.7%
2/43 • Number of events 2
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic pain
|
9.3%
4/43 • Number of events 4
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/43
|
4.0%
2/50 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary lesion
|
0.00%
0/43
|
6.0%
3/50 • Number of events 3
|
Additional Information
Narinder Shargill, Vice President, Global Medical and Clinical Affairs
Pulmonx
Phone: 650-216-0108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place