Emphysema
Conditions
Brief summary
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Detailed description
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.
Interventions
DEVICELVRC System
Sponsors
PneumRx, Inc.
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
36 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009. 2. Subject has post-bronchodilator FEV1 ≤45% predicted. 3. Subject has residual volume (RV) ≥175% predicted. 4. Subject has stopped smoking for at least 8 weeks prior to entering the study, as confirmed by a Cotinine test or other appropriate diagnostic test. 5. Subject has read, understood and signed the Informed Consent form. 6. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
Exclusion criteria
1. Subject has severe homogeneous emphysema as determined by the Core Radiology Lab 2. Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea. 3. Subject has a change in FEV1 \>20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of \> 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma. 4. Subject has DLCO \<20% of predicted. 5. Subject has severe gas exchange abnormalities as defined by: PaCO2 \>55 mm Hg PaO2 \<45 mm Hg on room air (High altitude criterion: PaO2 \<30 mm Hg) 6. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment. 7. Subject has severe pulmonary hypertension. If pulmonary hypertension is present, severe is defined by right ventricular systolic pressure \>50 mm Hg via right heart catheterization and/or echocardiogram. 8. Subject has an inability to walk \>140 meters (150 yards) in 6 minutes. 9. Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study. 10. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe. 11. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia. 12. Subject has clinically significant bronchiectasis. 13. Subject has giant bullae \>1/3 lung volume. 14. Subject has had previous LVR surgery, lung transplantation, lobectomy, LVR devices or other devices to treat COPD in either lung. 15. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study. 16. Subject is taking \>20 mg prednisone (or equivalent dose of a similar steroid) daily. 17. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder. 18. Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure. 19. Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals. 20. Subject has a known sensitivity to drugs required to perform bronchoscopy. 21. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD). 22. Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Six Minute Walk Test (6MWT) | Change in Baseline to 12 months | Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Forced Expiratory Volume in One Second (FEV1) | Change in Baseline to 12 months | The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function. |
| Mean Change in Residual Volume (RV) | Change in Baseline to 12 months | Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures. |
| Mean Change in St. Georges Respiratory Questionnaire (SGRQ) | Change in Baseline to 12 months | Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference. |
Countries
Canada, France, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LVRC System The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | LVRC System |
|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Forced Expiratory Volume in one second (FEV1) | 0.7 Liters STANDARD_DEVIATION 0.2 |
| Residual Volume (RV) | 5.2 Liters STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 44 Participants |
| Six Minute Walk Test (6MWT) | 313.6 meters STANDARD_DEVIATION 82 |
| St. George's Respiratory Questionnaire (SGRQ) | 57.9 units of a scale STANDARD_DEVIATION 15.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 101 |
| other Total, other adverse events | 97 / 101 |
| serious Total, serious adverse events | 56 / 101 |
Outcome results
Primary
Mean Change in Six Minute Walk Test (6MWT)
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame: Change in Baseline to 12 months
Population: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVRC System | Mean Change in Six Minute Walk Test (6MWT) | -22.9 meters | Standard Deviation 72.6 |
Secondary
Mean Change in Residual Volume (RV)
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Time frame: Change in Baseline to 12 months
Population: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVRC System | Mean Change in Residual Volume (RV) | -0.3 Liters | Standard Deviation 0.7 |
Secondary
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.
Time frame: Change in Baseline to 12 months
Population: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVRC System | Mean Change in St. Georges Respiratory Questionnaire (SGRQ) | -4.8 units on a scale | Standard Deviation 14.8 |
Secondary
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Time frame: Change in Baseline to 12 months
Population: Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LVRC System | Mean Percent Change in Forced Expiratory Volume in One Second (FEV1) | 2.2 % change | Standard Deviation 21.1 |