Clinical trial NCT01812447: Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 172
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: Target lobe volume reduction as measured by QCT
timeFrame: Baseline and 6 Months
measure: Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)
timeFrame: Baseline and 6 Months
measure: Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline and 6 Months
measure: Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
timeFrame: Baseline and 6 Months
measure: Exercise capacity as measured by Six Minute Walk Test (6MWT)
timeFrame: Baseline and 6 Months
measure: FEV1 Responders, defined as those achieving at least 15% improvement from baseline
timeFrame: Baseline and 6 Months
Other outcomes:
measure: Incidence of thoracic SAEs
timeFrame: Baseline and 6 months
Locations:
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University Hospital
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Farmington Hills
country: United States
facility: Beaumont Botsford Hospital (DCRC)
state: Michigan
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Cornell NYPH
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Clackamas
country: United States
facility: Kaiser Permanente Northwest Medical Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Michael DeBakey VA Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Medical Center
state: Vermont
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Québec
country: Canada
facility: Laval University
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.