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

NCT01812447 | Completed DMC

• 1 other identifier: CPR-03434
• Study Type: interventional
• Target: 172
• Locations: 2 countries
• Sites: 34

Brief Summary

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.

Conditions

Emphysema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (1)

• Incidence of thoracic SAEs

  Baseline and 6 months

Study Arms (3)

Spiration Valve System

EXPERIMENTAL

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; Other: Medical Management

Spiration Valve System, α-1

EXPERIMENTAL

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; Other: Medical Management

Medical Management

ACTIVE COMPARATOR

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

Interventions

Spiration Valve System DEVICE

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.

Spiration Valve System; Spiration Valve System, α-1

Medical Management OTHER

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.

Medical Management; Spiration Valve System; Spiration Valve System, α-1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead

Study Sites (34)

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32216, United States

Location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

University of Chicago

Chicago, Illinois, 60561, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Louisiana State University Hospital

Shreveport, Louisiana, 71130, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Beaumont Botsford Hospital (DCRC)

Farmington Hills, Michigan, 48336, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Cornell NYPH

New York, New York, 10065, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Kaiser Permanente Northwest Medical Center

Clackamas, Oregon, 97015, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Michael DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Fletcher Allen Medical Center

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (3)

• 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.

  PMID: 31365298 RESULT

• Hogarth DK, Delage A, Zgoda MA, Nsiah-Dosu S, Himes D, Reed MF. Efficacy and safety of the Spiration Valve System for the treatment of severe emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE). Respir Med. 2024 Apr;224:107565. doi: 10.1016/j.rmed.2024.107565. Epub 2024 Feb 14.

  PMID: 38364975 RESULT

• Criner GJ, Mallea JM, Abu-Hijleh M, Sachdeva A, Kalhan R, Hergott CA, Lazarus DR, Mularski RA, Calero K, Reed MF, Nsiah-Dosu S, Himes D, Kubo H, Kinsey CM, Majid A, Hogarth DK, Kaplan PV, Case AH, Makani SS, Chen TM, Delage A, Zgoda M, Shepherd RW. Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE. Ann Am Thorac Soc. 2024 Feb;21(2):251-260. doi: 10.1513/AnnalsATS.202306-520OC.

  PMID: 37948704 RESULT

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 18, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (32); CA (2)