Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function

Study Overview
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Brief Summary
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EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the safety and long-term effectiveness of the Spiration Valve System in patients with emphysema. Patients appropriate for the EMPROVE study are those who are currently on medical treatment but still symptomatic. EMPROVE also accepts α-1 antitrypsin deficiency patients.

Detailed Description
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The Spiration Valve is a small, one-way valve that is used to block air from entering diseased portions of the lung. This helps to reduce the volume in diseased lung due to hyperinflation. Volume reduction of diseased lung has been shown to improve lung function and other quality of life measures for people living with emphysema. The Spiration Valve is placed in the diseased section of the lungs using a tool called a bronchoscope. A bronchoscope is a small tube that has a camera on the end. The bronchoscope enters the lungs through the mouth. The Spiration Valve is delivered and placed in the targeted airways via another thin tube called a catheter that travels through the bronchoscope. Once in place, the Spiration Valve expands and contracts with breathing, creating a complete seal around the airway The seal blocks air from entering the target lobe while at the same time allowing trapped air and fluids to escape. This causes the diseased (hyper-inflated) lung to reduce in volume or collapse Studies have shown volume reduction may allow healthier lung to function better More information and a description of the Spiration Valve System can be found on the EMPROVE clinical trial website, www.EmphysemaTrial.com Safety and outcomes of the Spiration Valve System in emphysema have been published in several peer-reviewed journals. The articles listed below represent a summary of existing literature regarding the use of the Spiration Valve System for the treatment of emphysema. The selected articles are being provided to help understand the body of data describing the use of the Spiration Valve System. Unilateral Versus Bilateral Endoscopic Lung Volume Reduction: A Comparative Case Study, NCT00995852 Eberhardt R, Gompelmann D, Schuhmann M, Heussel CP, Herth FJ. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908 Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve), NCT00475007 Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA, Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014 Oct;21(4):288-297 European Multi-Center Post Market Study of the IBV Valve System, NCT00880724 Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-1325

Official Title
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A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for the Single Lobe Treatment of Severe Emphysema

Conditions
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Emphysema

Intervention / Treatment
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* Device: Spiration Valve System
* Other: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has severe and heterogeneous emphysema with severe dyspnea Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study Pulmonary Function Testing Results (PFT's) demonstrate: FEV1 ≤ 45% of predicted RV ≥ 150% of predicted TLC ≥ 100% of predicted Exclusion Criteria: Patient has a BMI < 15 kg/m2 Arterial Blood Gas Level (ABG) indicates: PCO2 > 55 mm Hg PO2 < 45 mm Hg on room air Subject has a diffuse emphysema pattern Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day Subject has an active asthma (>15 mg of prednisone daily) Giant bulla (> 1/3 volume of lung) Pulmonary hypertension Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spiration Valve System<br>Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. | Device: Spiration Valve System<br>* Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.<br>Other: Medical Management<br>* Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.<br>|
| Experimental: Spiration Valve System, α-1<br>α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group. | Device: Spiration Valve System<br>* Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.<br>Other: Medical Management<br>* Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.<br>|
| Active Comparator: Medical Management<br>The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure. | Other: Medical Management<br>* Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary effectiveness endpoint will be the difference between the treatment and control groups in the mean change in forced expiratory volume in 1 second (FEV1) |  | Baseline and 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lobe volume reduction as measured by QCT |  | Baseline and 6 Months | 
| Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC) |  | Baseline and 6 Months | 
| Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) |  | Baseline and 6 Months | 
| Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC) |  | Baseline and 6 Months | 
| Exercise capacity as measured by Six Minute Walk Test (6MWT) |  | Baseline and 6 Months | 
| FEV1 Responders, defined as those achieving at least 15% improvement from baseline |  | Baseline and 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease