Trial Outcomes & Findings for Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study) (NCT NCT01796392)
NCT ID: NCT01796392
Last Updated: 2023-06-15
Results Overview
The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of \>15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
1 year
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
EBV and Optimal Medical Management
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
62
|
|
Overall Study
COMPLETED
|
119
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
EBV and Optimal Medical Management
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
5
|
1
|
|
Overall Study
Excluded for medical reasons
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Baseline characteristics by cohort
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 Participants
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 Participants
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 6.9 • n=128 Participants
|
62.5 years
STANDARD_DEVIATION 7.1 • n=62 Participants
|
63.5 years
STANDARD_DEVIATION 7.0 • n=190 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=128 Participants
|
29 Participants
n=62 Participants
|
101 Participants
n=190 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=128 Participants
|
33 Participants
n=62 Participants
|
89 Participants
n=190 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=128 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=128 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=128 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=128 Participants
|
3 Participants
n=62 Participants
|
11 Participants
n=190 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=128 Participants
|
57 Participants
n=62 Participants
|
174 Participants
n=190 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=128 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=128 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=190 Participants
|
|
Region of Enrollment
Netherlands
|
17 participants
n=128 Participants
|
8 participants
n=62 Participants
|
25 participants
n=190 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=128 Participants
|
42 participants
n=62 Participants
|
130 participants
n=190 Participants
|
|
Region of Enrollment
Brazil
|
13 participants
n=128 Participants
|
6 participants
n=62 Participants
|
19 participants
n=190 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=128 Participants
|
6 participants
n=62 Participants
|
16 participants
n=190 Participants
|
|
Height
|
65.7 inches
STANDARD_DEVIATION 4.0 • n=128 Participants
|
66.3 inches
STANDARD_DEVIATION 3.4 • n=62 Participants
|
65.9 inches
STANDARD_DEVIATION 3.9 • n=190 Participants
|
|
BMI
|
24.7 kg/m2
STANDARD_DEVIATION 3.9 • n=128 Participants
|
24.3 kg/m2
STANDARD_DEVIATION 4.4 • n=62 Participants
|
24.6 kg/m2
STANDARD_DEVIATION 4.1 • n=190 Participants
|
|
Pack Years Smoking History
|
50.8 pack-years
STANDARD_DEVIATION 26.9 • n=128 Participants
|
48.6 pack-years
STANDARD_DEVIATION 28.5 • n=62 Participants
|
50.1 pack-years
STANDARD_DEVIATION 27.4 • n=190 Participants
|
|
FEV1 Post-Bronchodilator (liters)
|
0.8 liters
STANDARD_DEVIATION 0.3 • n=128 Participants
|
0.8 liters
STANDARD_DEVIATION 0.2 • n=62 Participants
|
0.8 liters
STANDARD_DEVIATION 0.2 • n=190 Participants
|
|
FEV1 Post-Bronchodilator (% predicted)
|
28.0 %predicted
STANDARD_DEVIATION 7.5 • n=128 Participants
|
26.2 %predicted
STANDARD_DEVIATION 6.3 • n=62 Participants
|
27.4 %predicted
STANDARD_DEVIATION 7.1 • n=190 Participants
|
|
FVC (liters)
|
2.6 liters
STANDARD_DEVIATION 0.9 • n=128 Participants
|
2.6 liters
STANDARD_DEVIATION 0.8 • n=62 Participants
|
2.6 liters
STANDARD_DEVIATION 0.8 • n=190 Participants
|
|
FVC (% predicted)
|
71.2 %predicted
STANDARD_DEVIATION 16.0 • n=128 Participants
|
68.5 %predicted
STANDARD_DEVIATION 13.6 • n=62 Participants
|
70.3 %predicted
STANDARD_DEVIATION 15.3 • n=190 Participants
|
|
Diffusing Capacity (mL CO/min/mm Hg)
|
8.5 mL CO / min / mmHg
STANDARD_DEVIATION 3.5 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
8.3 mL CO / min / mmHg
STANDARD_DEVIATION 2.7 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
8.5 mL CO / min / mmHg
STANDARD_DEVIATION 3.2 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
Diffusing Capacity (% predicted)
|
34.6 %predicted
STANDARD_DEVIATION 11.3 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
33.1 %predicted
STANDARD_DEVIATION 9.8 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
34.1 %predicted
STANDARD_DEVIATION 10.9 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
Residual Volume (RV) (liters)
|
4.7 liters
STANDARD_DEVIATION 1.1 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
4.8 liters
STANDARD_DEVIATION 0.9 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
4.7 liters
STANDARD_DEVIATION 1.0 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
Residual Volume (% predicted)
|
224.5 %predicted
STANDARD_DEVIATION 42.5 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
224.6 %predicted
STANDARD_DEVIATION 38.9 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
224.5 %predicted
STANDARD_DEVIATION 41.2 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
Total Lung Capacity (TLC) (liters)
|
7.5 liters
STANDARD_DEVIATION 1.6 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
7.6 liters
STANDARD_DEVIATION 1.4 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
7.6 liters
STANDARD_DEVIATION 1.5 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
Total Lung Capacity (% predicted)
|
133.5 %predicted
STANDARD_DEVIATION 21.2 • n=126 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
130.2 %predicted
STANDARD_DEVIATION 12.4 • n=61 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
132.4 %predicted
STANDARD_DEVIATION 18.8 • n=187 Participants • Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
GOLD Stage
GOLD Stage III
|
54 Participants
n=128 Participants
|
16 Participants
n=62 Participants
|
70 Participants
n=190 Participants
|
|
GOLD Stage
GOLD Stage IV
|
74 Participants
n=128 Participants
|
46 Participants
n=62 Participants
|
120 Participants
n=190 Participants
|
|
6 Minute Walk Distance (m)
|
311.3 meters
STANDARD_DEVIATION 81.3 • n=128 Participants
|
301.9 meters
STANDARD_DEVIATION 78.5 • n=62 Participants
|
308.3 meters
STANDARD_DEVIATION 80.3 • n=190 Participants
|
|
SGRQ Total score
|
55.2 score on a scale
STANDARD_DEVIATION 14.1 • n=127 Participants • Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
53.1 score on a scale
STANDARD_DEVIATION 14.1 • n=61 Participants • Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
54.5 score on a scale
STANDARD_DEVIATION 14.1 • n=188 Participants • Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data.
|
|
mMRC Dyspnea Grade score
|
2.4 score
STANDARD_DEVIATION 1.0 • n=126 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
2.2 score
STANDARD_DEVIATION 0.8 • n=62 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
2.4 score
STANDARD_DEVIATION 0.9 • n=188 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
|
BODE Index
|
5.3 Index
STANDARD_DEVIATION 1.5 • n=126 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
5.3 Index
STANDARD_DEVIATION 1.6 • n=62 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
5.3 Index
STANDARD_DEVIATION 1.5 • n=188 Participants • Only 126 EBV subjects were analyzed, due to missing data.
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-to-Treat Population
The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of \>15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.
Outcome measures
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 Participants
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 Participants
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
Forced Expiratory Volume in 1-second (FEV1)
|
61 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat
Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).
Outcome measures
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 Participants
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 Participants
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
FEV1 Post-bronchodilator Absolute Change
|
0.1 liters
Standard Deviation 0.2
|
-0.003 liters
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat
Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 Participants
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 Participants
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ)
|
-7.6 score on a scale
Standard Deviation 15.7
|
-0.5 score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat
Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).
Outcome measures
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 Participants
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 Participants
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
6-minute Walk Distance
|
13.0 meters
Standard Deviation 81.5
|
-26.3 meters
Standard Deviation 81.5
|
Adverse Events
Zephyr Valve Treatment and Optimal Medical Management
Serious events: 77 serious events
Other events: 124 other events
Deaths: 5 deaths
Optimal Medical Management
Serious events: 24 serious events
Other events: 46 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 participants at risk
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 participants at risk
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.78%
1/128 • Number of events 1 • 1 year
|
3.2%
2/62 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
General disorders
Chest pain
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
General disorders
Hernia
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
General disorders
Ulcer haemorrhage
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.78%
1/128 • Number of events 1 • 1 year
|
3.2%
2/62 • Number of events 2 • 1 year
|
|
Infections and infestations
Herpes zoster
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Infections and infestations
Infection
|
1.6%
2/128 • Number of events 2 • 1 year
|
0.00%
0/62 • 1 year
|
|
Infections and infestations
Pneumonia
|
6.2%
8/128 • Number of events 8 • 1 year
|
8.1%
5/62 • Number of events 6 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
1/128 • Number of events 3 • 1 year
|
0.00%
0/62 • 1 year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Nervous system disorders
Facial paralysis
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Nervous system disorders
Sedation
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Product Issues
Device dislocation
|
1.6%
2/128 • Number of events 2 • 1 year
|
0.00%
0/62 • 1 year
|
|
Product Issues
Device expulsion
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
1.6%
2/128 • Number of events 2 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
27.3%
35/128 • Number of events 50 • 1 year
|
33.9%
21/62 • Number of events 32 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/128 • Number of events 7 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
2/128 • Number of events 2 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
3/128 • Number of events 3 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
31.2%
40/128 • Number of events 42 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/128 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
3/128 • Number of events 3 • 1 year
|
3.2%
2/62 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.78%
1/128 • Number of events 1 • 1 year
|
0.00%
0/62 • 1 year
|
Other adverse events
| Measure |
Zephyr Valve Treatment and Optimal Medical Management
n=128 participants at risk
This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
Optimal Medical Management
n=62 participants at risk
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
4.7%
6/128 • Number of events 7 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
6.2%
8/128 • Number of events 9 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
4/128 • Number of events 4 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
5.5%
7/128 • Number of events 7 • 1 year
|
0.00%
0/62 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.8%
10/128 • Number of events 11 • 1 year
|
0.00%
0/62 • 1 year
|
|
General disorders
Chest discomfort
|
6.2%
8/128 • Number of events 8 • 1 year
|
0.00%
0/62 • 1 year
|
|
General disorders
Chest pain
|
28.1%
36/128 • Number of events 46 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
General disorders
Oedema peripheral
|
3.1%
4/128 • Number of events 4 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
3.1%
4/128 • Number of events 4 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis
|
5.5%
7/128 • Number of events 8 • 1 year
|
6.5%
4/62 • Number of events 4 • 1 year
|
|
Infections and infestations
Infection
|
8.6%
11/128 • Number of events 12 • 1 year
|
8.1%
5/62 • Number of events 5 • 1 year
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/128 • 1 year
|
3.2%
2/62 • Number of events 2 • 1 year
|
|
Infections and infestations
Pneumonia
|
7.0%
9/128 • Number of events 10 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
2.3%
3/128 • Number of events 3 • 1 year
|
4.8%
3/62 • Number of events 3 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
8/128 • Number of events 8 • 1 year
|
0.00%
0/62 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.3%
3/128 • Number of events 3 • 1 year
|
6.5%
4/62 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
4/128 • Number of events 4 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
4/128 • Number of events 4 • 1 year
|
0.00%
0/62 • 1 year
|
|
Nervous system disorders
Dizziness
|
3.9%
5/128 • Number of events 5 • 1 year
|
0.00%
0/62 • 1 year
|
|
Nervous system disorders
Headache
|
8.6%
11/128 • Number of events 15 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/128 • 1 year
|
3.2%
2/62 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
46.9%
60/128 • Number of events 99 • 1 year
|
40.3%
25/62 • Number of events 46 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
25/128 • Number of events 31 • 1 year
|
8.1%
5/62 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.7%
29/128 • Number of events 34 • 1 year
|
4.8%
3/62 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
15.6%
20/128 • Number of events 24 • 1 year
|
1.6%
1/62 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.5%
7/128 • Number of events 7 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
5.5%
7/128 • Number of events 8 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
10/128 • Number of events 10 • 1 year
|
4.8%
3/62 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.5%
7/128 • Number of events 7 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.7%
6/128 • Number of events 6 • 1 year
|
0.00%
0/62 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
5.5%
7/128 • Number of events 8 • 1 year
|
4.8%
3/62 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
3.1%
4/128 • Number of events 4 • 1 year
|
0.00%
0/62 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place