Trial Outcomes & Findings for Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema (NCT NCT03360396)
NCT ID: NCT03360396
Last Updated: 2023-08-28
Results Overview
Percent change in FEV1
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
6 months
Results posted on
2023-08-28
Participant Flow
Participant milestones
| Measure |
Endobronchial Coils
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
Medically-managed control group
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
40
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Baseline characteristics by cohort
| Measure |
Endobronchial Coils
n=80 Participants
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
n=40 Participants
Medically-managed control group
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1)
|
0.8 Litres
STANDARD_DEVIATION 0.2026 • n=5 Participants
|
0.8 Litres
STANDARD_DEVIATION 0.2220 • n=7 Participants
|
0.8 Litres
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
St. George Respiratory Questionnaire Score (SGRQ)
|
59.327 units on a scale
STANDARD_DEVIATION 11.4232 • n=5 Participants
|
54.666 units on a scale
STANDARD_DEVIATION 14.5222 • n=7 Participants
|
57.8 units on a scale
STANDARD_DEVIATION 12.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent change in FEV1
Outcome measures
| Measure |
Endobronchial Coils
n=57 Participants
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
n=34 Participants
Medically-managed control group
|
|---|---|---|
|
Percent Change in FEV1 at 6 Months
|
12.745 percent change from baseline
Standard Deviation 33.1782
|
-2.604 percent change from baseline
Standard Deviation 10.1628
|
PRIMARY outcome
Timeframe: 6 monthsChange in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Outcome measures
| Measure |
Endobronchial Coils
n=54 Participants
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
n=33 Participants
Medically-managed control group
|
|---|---|---|
|
Absolute Change in SGRQ Score at 6 Months
|
-8.561 score on a scale
Standard Deviation 14.6834
|
2.080 score on a scale
Standard Deviation 9.8483
|
POST_HOC outcome
Timeframe: 36 monthsPopulation: Global study was terminated early; however, French Authorities required French participants to be followed through 36-months for safety only. Only subjects that received treatment with Endobronchial Coil System (randomized and crossover control participants) are included in this outcome.
Number of French participants who received treatment with Endobronchial Coil System (randomized and crossover participants) that completed the 36 month follow up visit. All control participants who exited after 6 months are excluded for this outcome.
Outcome measures
| Measure |
Endobronchial Coils
n=46 Participants
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
Medically-managed control group
|
|---|---|---|
|
36 Month Follow Up Visit Completion for French Participants (N=46)
|
17 participants
|
—
|
POST_HOC outcome
Timeframe: 36 monthsPopulation: Global study was terminated early; however, French Authorities required French participants to be followed through 36-months for safety only.
Number of deaths for French participants through 36 months. All control participants who exited after 6 months are excluded for this outcome.
Outcome measures
| Measure |
Endobronchial Coils
n=46 Participants
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
Medically-managed control group
|
|---|---|---|
|
Crude Mortality for French Participants (N=46)
|
5 Participants
|
0 Participants
|
Adverse Events
Endobronchial Coils
Serious events: 30 serious events
Other events: 39 other events
Deaths: 5 deaths
Control
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endobronchial Coils
n=73 participants at risk
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
n=40 participants at risk
Medically-managed control group
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
11.0%
8/73 • Number of events 8 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Bronchitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Enterococcal infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Influenza
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Respiratory Tract Infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
urosepsis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
infective exacerbation of COPD
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
4.1%
3/73 • Number of events 3 • 6 months
|
7.5%
3/40 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.1%
3/73 • Number of events 3 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnoea
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.7%
2/73 • Number of events 3 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnea
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm malignant
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
renal cancer
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Cardiac disorders
atrial fibrillation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Gastrointestinal disorders
constipation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
General disorders
death
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Injury, poisoning and procedural complications
road traffic accident
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Product Issues
device dislocation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
Other adverse events
| Measure |
Endobronchial Coils
n=73 participants at risk
Treatment with PneumRx Endobronchial Coil System
Endobronchial Coils: Endobronchial Coil implants
|
Control
n=40 participants at risk
Medically-managed control group
|
|---|---|---|
|
Ear and labyrinth disorders
Ear Haemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal Tract Irritation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
General disorders
Chest Pain
|
13.7%
10/73 • Number of events 12 • 6 months
|
0.00%
0/40 • 6 months
|
|
General disorders
Fatigue
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
General disorders
Non-Cardiac Chest Pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
bronchitis
|
11.0%
8/73 • Number of events 9 • 6 months
|
10.0%
4/40 • Number of events 4 • 6 months
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Infections and infestations
Infected Dermal Cyst
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Influenza
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Lung Infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Oral Candidiasis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Pneumonia
|
13.7%
10/73 • Number of events 11 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Tooth Abscess
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 2 • 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Renal and urinary disorders
Urinary Retention
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
15.1%
11/73 • Number of events 13 • 6 months
|
12.5%
5/40 • Number of events 5 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
6/73 • Number of events 8 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
27.4%
20/73 • Number of events 28 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/73 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place