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Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study) (LIBERATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01796392
Recruitment Status : Active, not recruiting
First Posted : February 21, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Emphysema
Interventions Device: EBV
Other: Optimal Medical Management
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EBV and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 128 62
Completed 119 [1] 59 [2]
Not Completed 9 3
Reason Not Completed
Withdrawal by Subject             2             0
Death             5             1
Excluded for medical reasons             1             2
Lost to Follow-up             1             0
[1]
119 active subjects at 12-months
[2]
59 active subjects at 12-months
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 128 62 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 62 participants 190 participants
64  (6.9) 62.5  (7.1) 63.5  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 62 participants 190 participants
Female
72
  56.3%
29
  46.8%
101
  53.2%
Male
56
  43.8%
33
  53.2%
89
  46.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 62 participants 190 participants
American Indian or Alaska Native
1
   0.8%
0
   0.0%
1
   0.5%
Asian
1
   0.8%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   6.3%
3
   4.8%
11
   5.8%
White
117
  91.4%
57
  91.9%
174
  91.6%
More than one race
1
   0.8%
1
   1.6%
2
   1.1%
Unknown or Not Reported
0
   0.0%
1
   1.6%
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 128 participants 62 participants 190 participants
17 8 25
United States Number Analyzed 128 participants 62 participants 190 participants
88 42 130
Brazil Number Analyzed 128 participants 62 participants 190 participants
13 6 19
United Kingdom Number Analyzed 128 participants 62 participants 190 participants
10 6 16
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 128 participants 62 participants 190 participants
65.7  (4.0) 66.3  (3.4) 65.9  (3.9)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 128 participants 62 participants 190 participants
24.7  (3.9) 24.3  (4.4) 24.6  (4.1)
Pack Years Smoking History   [1] 
Mean (Standard Deviation)
Unit of measure:  Pack-years
Number Analyzed 128 participants 62 participants 190 participants
50.8  (26.9) 48.6  (28.5) 50.1  (27.4)
[1]
Measure Description: Calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
FEV1 Post-Bronchodilator (liters)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 128 participants 62 participants 190 participants
0.8  (0.3) 0.8  (0.2) 0.8  (0.2)
FEV1 Post-Bronchodilator (% predicted)  
Mean (Standard Deviation)
Unit of measure:  %predicted
Number Analyzed 128 participants 62 participants 190 participants
28.0  (7.5) 26.2  (6.3) 27.4  (7.1)
FVC (liters)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 128 participants 62 participants 190 participants
2.6  (0.9) 2.6  (0.8) 2.6  (0.8)
FVC (% predicted)  
Mean (Standard Deviation)
Unit of measure:  %predicted
Number Analyzed 128 participants 62 participants 190 participants
71.2  (16.0) 68.5  (13.6) 70.3  (15.3)
Diffusing Capacity (mL CO/min/mm Hg)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL CO / min / mmHg
Number Analyzed 126 participants 61 participants 187 participants
8.5  (3.5) 8.3  (2.7) 8.5  (3.2)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Diffusing Capacity (% predicted)   [1] 
Mean (Standard Deviation)
Unit of measure:  %predicted
Number Analyzed 126 participants 61 participants 187 participants
34.6  (11.3) 33.1  (9.8) 34.1  (10.9)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Residual Volume (RV) (liters)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 126 participants 61 participants 187 participants
4.7  (1.1) 4.8  (0.9) 4.7  (1.0)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Residual Volume (% predicted)   [1] 
Mean (Standard Deviation)
Unit of measure:  %predicted
Number Analyzed 126 participants 61 participants 187 participants
224.5  (42.5) 224.6  (38.9) 224.5  (41.2)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Total Lung Capacity (TLC) (liters)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 126 participants 61 participants 187 participants
7.5  (1.6) 7.6  (1.4) 7.6  (1.5)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
Total Lung Capacity (% predicted)   [1] 
Mean (Standard Deviation)
Unit of measure:  %predicted
Number Analyzed 126 participants 61 participants 187 participants
133.5  (21.2) 130.2  (12.4) 132.4  (18.8)
[1]
Measure Analysis Population Description: Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.
GOLD Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 62 participants 190 participants
GOLD Stage III
54
  42.2%
16
  25.8%
70
  36.8%
GOLD Stage IV
74
  57.8%
46
  74.2%
120
  63.2%
[1]
Measure Description: The GOLD system uses the term “stages” to refer to the different levels of COPD. Participants graded as GOLD Stage III are considered to have Severe COPD. Participants graded as GOLD Stage IV are considered to have Very Severe COPD.
6 Minute Walk Distance (m)  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 128 participants 62 participants 190 participants
311.3  (81.3) 301.9  (78.5) 308.3  (80.3)
SGRQ Total score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 127 participants 61 participants 188 participants
55.2  (14.1) 53.1  (14.1) 54.5  (14.1)
[1]
Measure Description:

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.

[2]
Measure Analysis Population Description: Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data.
mMRC Dyspnea Grade score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 126 participants 62 participants 188 participants
2.4  (1.0) 2.2  (0.8) 2.4  (0.9)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Only 126 EBV subjects were analyzed, due to missing data.
BODE Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Index
Number Analyzed 126 participants 62 participants 188 participants
5.3  (1.5) 5.3  (1.6) 5.3  (1.5)
[1]
Measure Description:

The BODE Index is comprised of a person's body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E"). Each of these components is graded on a scale of either 0 to 1 or 0 to 3. The final value—ranging from 0 to 10—provides doctors a percentage of how likely a person is to survive for four years. The final BODE tabulation is described as follows:

0 to 2 points: 80 percent likelihood of survival 3 to 4 points: 67 percent likelihood of survival 5 of 6 points: 57 percent likelihood of survival 7 to 10 points: 18 percent likelihood of survival

[2]
Measure Analysis Population Description: Only 126 EBV subjects were analyzed, due to missing data.
1.Primary Outcome
Title Forced Expiratory Volume in 1-second (FEV1)
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 128 62
Measure Type: Count of Participants
Unit of Measure: Participants
61
  47.7%
10
  16.1%
2.Secondary Outcome
Title FEV1 Post-bronchodilator Absolute Change
Hide Description 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).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 128 62
Mean (Standard Deviation)
Unit of Measure: liters
0.1  (0.2) -0.003  (0.2)
3.Secondary Outcome
Title St. George's Respiratory Questionnaire (SGRQ)
Hide Description

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.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 128 62
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.6  (15.7) -0.5  (15.5)
4.Secondary Outcome
Title 6-minute Walk Distance
Hide Description Difference between study arms in ‘absolute and percentage change from baseline’ for 6MWD at 1 year (value at 1 year minus value at baseline).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 128 62
Mean (Standard Deviation)
Unit of Measure: meters
13.0  (81.5) -26.3  (81.5)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   5/128 (3.91%)      1/62 (1.61%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/128 (60.16%)      24/62 (38.71%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Arrhythmia * 1  1/128 (0.78%)  1 2/62 (3.23%)  2
Cardiac failure * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Myocardial infarction * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Gastrointestinal disorders     
Diverticular perforation * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Inguinal hernia * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Vomiting * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
General disorders     
Chest pain * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Hernia * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Ulcer haemorrhage * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Infections and infestations     
Diverticulitis * 1  1/128 (0.78%)  1 2/62 (3.23%)  2
Herpes zoster * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Infection * 1  2/128 (1.56%)  2 0/62 (0.00%)  0
Pneumonia * 1  8/128 (6.25%)  8 5/62 (8.06%)  6
Respiratory tract infection * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Urinary tract infection * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Injury, poisoning and procedural complications     
Anaesthetic complication pulmonary * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Fall * 1  1/128 (0.78%)  3 0/62 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Malnutrition * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Oesophageal carcinoma * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Nervous system disorders     
Facial paralysis * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Guillain-Barre syndrome * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Loss of consciousness * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Sedation * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Product Issues     
Device dislocation * 1  2/128 (1.56%)  2 0/62 (0.00%)  0
Device expulsion * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Psychiatric disorders     
Alcohol abuse * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Delirium * 1  2/128 (1.56%)  2 0/62 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  35/128 (27.34%)  50 21/62 (33.87%)  32
Dyspnoea * 1  4/128 (3.13%)  7 0/62 (0.00%)  0
Haemoptysis * 1  2/128 (1.56%)  2 0/62 (0.00%)  0
Pleural effusion * 1  3/128 (2.34%)  3 0/62 (0.00%)  0
Pneumothorax * 1  40/128 (31.25%)  42 0/62 (0.00%)  0
Pulmonary embolism * 1  0/128 (0.00%)  0 1/62 (1.61%)  1
Pulmonary mass * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Respiratory failure * 1  3/128 (2.34%)  3 2/62 (3.23%)  3
Skin and subcutaneous tissue disorders     
Subcutaneous emphysema * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
Surgical and medical procedures     
Umbilical hernia repair * 1  1/128 (0.78%)  1 0/62 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Zephyr Valve Treatment and Optimal Medical Management Optimal Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/128 (96.88%)      46/62 (74.19%)    
Cardiac disorders     
Arrhythmia * 1  6/128 (4.69%)  7 0/62 (0.00%)  0
Gastrointestinal disorders     
Constipation * 1  8/128 (6.25%)  9 0/62 (0.00%)  0
Dyspepsia * 1  4/128 (3.13%)  4 0/62 (0.00%)  0
Functional gastrointestinal disorder * 1  7/128 (5.47%)  7 0/62 (0.00%)  0
Nausea * 1  10/128 (7.81%)  11 0/62 (0.00%)  0
General disorders     
Chest discomfort * 1  8/128 (6.25%)  8 0/62 (0.00%)  0
Chest pain * 1  36/128 (28.13%)  46 1/62 (1.61%)  1
Oedema peripheral * 1  4/128 (3.13%)  4 1/62 (1.61%)  1
Pyrexia * 1  4/128 (3.13%)  4 1/62 (1.61%)  1
Infections and infestations     
Bronchitis * 1  7/128 (5.47%)  8 4/62 (6.45%)  4
Infection * 1  11/128 (8.59%)  12 5/62 (8.06%)  5
Pharyngitis * 1  0/128 (0.00%)  0 2/62 (3.23%)  2
Pneumonia * 1  9/128 (7.03%)  10 1/62 (1.61%)  1
Sinusitis * 1  3/128 (2.34%)  3 3/62 (4.84%)  3
Upper respiratory tract infection * 1  8/128 (6.25%)  8 0/62 (0.00%)  0
Urinary tract infection * 1  3/128 (2.34%)  3 4/62 (6.45%)  5
Musculoskeletal and connective tissue disorders     
Back pain * 1  4/128 (3.13%)  4 1/62 (1.61%)  1
Neck pain * 1  4/128 (3.13%)  4 0/62 (0.00%)  0
Nervous system disorders     
Dizziness * 1  5/128 (3.91%)  5 0/62 (0.00%)  0
Headache * 1  11/128 (8.59%)  15 1/62 (1.61%)  1
Renal and urinary disorders     
Nephrolithiasis * 1  0/128 (0.00%)  0 2/62 (3.23%)  2
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  60/128 (46.88%)  99 25/62 (40.32%)  46
Cough * 1  25/128 (19.53%)  31 5/62 (8.06%)  5
Dyspnoea * 1  29/128 (22.66%)  34 3/62 (4.84%)  3
Haemoptysis * 1  20/128 (15.63%)  24 1/62 (1.61%)  1
Hypoxia * 1  7/128 (5.47%)  7 0/62 (0.00%)  0
Lower respiratory tract congestion * 1  7/128 (5.47%)  8 0/62 (0.00%)  0
Oropharyngeal pain * 1  10/128 (7.81%)  10 3/62 (4.84%)  3
Pleural effusion * 1  7/128 (5.47%)  7 0/62 (0.00%)  0
Pneumothorax * 1  6/128 (4.69%)  6 0/62 (0.00%)  0
Pulmonary mass * 1  7/128 (5.47%)  8 3/62 (4.84%)  3
Sputum increased * 1  4/128 (3.13%)  4 0/62 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Narinder Shargill
Organization: Pulmonx Corporation
Phone: 650-216-0108
Responsible Party: Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT01796392     History of Changes
Other Study ID Numbers: 600-0012
First Submitted: February 20, 2013
First Posted: February 21, 2013
Results First Submitted: January 2, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019