ung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema

Completed

• Conditions: COPD emphysema; 10038716

• Registration Number: NL-OMON42116
• Lead Sponsor: PulmonX International Sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Signed Screening or Study Procedure Informed Consent using a form that was reviewed and approved by the IRB;
2. Age 40 to 75 years;
3. BMI less than 35 kg/m2;
4 Stable with less than 20 mg prednisone (or equivalent) per day;
5 Nonsmoking for 4 months prior to screening interview.
6.Completed a supervised pulmonary rehabilitation program less than equal to 6 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 6 months prior
7.FEV1 between 15% and 45% of predicted value at baseline exam
Post-rehabilitation 6-minute walk distance between 100 meters and 500 meters at baseline exam
8.Current Pneumococcus vaccination & Current Influenza vaccination
9.Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion Criteria

1. Currently enrolled in another clinical trial studying an experimental treatment;
2. Previously enrolled in this study for which protocol required follow up is not complete;
3. Clinically significant (greater than 4 tablespoons per day) sputum production;
4. Two or more COPD exacerbation episodes requiring hospitalization in the last year at screening;
5. Two or more instances of pneumonia episodes in the last year at screening;
6. Unplanned weight loss >10% usual weight <90 days prior to enrollment;
7. History of exercise-related syncope;
8. Myocardial Infarction or congestive heart failure within 6 months of screening;
9. Prior lung transplant, LVRS, bullectomy or lobectomy;
10. Clinically significant bronchiectasis;
11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days;
12. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of CorPulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit);
13. Pulmonary nodule requiring surgery as noted by chest X-ray or CT scan;
14. HRCT collected per CT scanning protocol within the last 3 months of screening date and evaluated by clinical site personnel using 510k cleared CT software shows:
a Parenchymal destruction score of greater than 75% in all three right lobes or both left lobes
b Emphysema heterogeneity score less than 15%
c Large bullae encompassing greater than 30% of either lung
d Insufficient landmarks to evaluate the CT study using the software as it is intended;
15. Left ventricular ejection fraction (LVEF) less than 45% as determined by recent echocardiogram (completed within the last 3 months prior to screening visit);
16. Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT;
17. Dysrhythmia that might pose a risk during exercise or training;
18. Post-bronchodilator FEV1 less than 15% or greater than 45% of predicted value at screening;
19. TLC less than 100% predicted (determined by body plethysmography) at screening;
20. RV less than 175% predicted (determined by body plethysmography) at screening;
21. DLCO less than 20% predicted value at screening;
22. 6-minute walk distance less than 100 meters or greater than 450 meters at screening;
23. PaCO2 greater than 50mm Hg (Denver greater than 55 mm Hg) on room air at screening;
24. PaO2 less than 45 mm Hg (Denver less than 30 mm Hg) on room air at screening;
25. Elevated white cell count (>10,000 cells/mcL) at screening;
26. Presence of alpha-1 anti-trypsin deficiency as determined by local laboratory ranges;
27. Plasma cotinine level greater than 13.7 ng/ml (or arterial carboxyhemoglobin > 2.5% if using nicotine products) at screening;
28. Any disease or condition that interferes with completion of initial or follow-up assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary effectiveness endpoint:<br /><br>The percentage of study participants in the EBV treatment arm meeting the<br /><br>clinically significant threshold of 15% or higher improved forced<br /><br>expiratory volume in one second (FEV1), obtained immediately following<br /><br>bronchodilator therapy, as compared to the percentage in the control arm at 1<br /><br>year post-procedure.<br /><br><br /><br>Primary safety Endpoint:<br /><br>Evaluation of the short- and long-term adverse events profile of the EBV<br /><br>treatment arm during the treatment period, defined as the day of the study<br /><br>procedure until 45 days after the study procedure (short), and in the<br /><br>post-treatment period, defined as 46 days after the study procedure until the<br /><br>1-year follow-up visit (long).</p><br>