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

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

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.

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Spiration Valve System; Other: Medical Management

Detailed Description

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.

1. 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

2. 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

3. 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

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • Quebec
    • Québec, Quebec, Canada, G1V 0A6
      • Laval University
• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Sparks Regional Medical Center
  • California
    • Riverside, California, United States, 92505
      • Kaiser Permanente Riverside Medical Center
    • San Diego, California, United States, 92103
      • University of California San Diego
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Mayo Clinic Jacksonville
    • Miami, Florida, United States, 33125
      • Miami VA Healthcare System
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60561
      • University of Chicago
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State University Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Beaumont Botsford Hospital (DCRC)
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • New York, New York, United States, 10065
      • Cornell NYPH
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Kaiser Permanente Northwest Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center at Dallas
    • Houston, Texas, United States, 77030
      • Michael Debakey VA Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical Management; 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; 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.
Experimental: Spiration Valve System; 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; 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.; Other: Medical Management; 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.
Experimental: Spiration Valve System, α-1; 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; 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.; Other: Medical Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of thoracic SAEs	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Spiration, Inc.

Publications and helpful links

General Publications

• Criner GJ, Delage A, Voelker K, Hogarth DK, Majid A, Zgoda M, Lazarus DR, Casal R, Benzaquen SB, Holladay RC, Wellikoff A, Calero K, Rumbak MJ, Branca PR, Abu-Hijleh M, Mallea JM, Kalhan R, Sachdeva A, Kinsey CM, Lamb CR, Reed MF, Abouzgheib WB, Kaplan PV, Marrujo GX, Johnstone DW, Gasparri MG, Meade AA, Hergott CA, Reddy C, Mularski RA, Case AH, Makani SS, Shepherd RW, Chen B, Holt GE, Martel S. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Lung Diseases; Chronic Obstructive Pulmonary Disease; Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Emphysema; Endobronchial Valves; Intrabronchial Valves; Bronchial Valve; Bronchoscopic Lung Volume Reduction; Respiratory Tract Disease; BLVR; TLVR; Pathologic Process
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CPR-03434