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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Spiration, Inc.
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT01812447
First received: March 7, 2013
Last updated: July 9, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Emphysema
Device: Spiration Valve System
Other: Medical Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spiration, Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target lobe volume reduction as measured by QCT [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Exercise capacity as measured by Six Minute Walk Test (6MWT) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • FEV1 Responders, defined as those achieving at least 15% improvement from baseline [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence of thoracic SAEs [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 270
Study Start Date: June 2013
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812447

  Show 29 Study Locations
Sponsors and Collaborators
Spiration, Inc.
  More Information

No publications provided

Responsible Party: Spiration, Inc.
ClinicalTrials.gov Identifier: NCT01812447     History of Changes
Other Study ID Numbers: CPR-03434
Study First Received: March 7, 2013
Last Updated: July 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Spiration, Inc.:
Emphysema
Pulmonary Emphysema
Endobronchial Valves
Intrabronchial Valves
Bronchial Valve
Chronic Obstructive Pulmonary Disease
COPD
Pulmonary Disease, Chronic Obstructive
Bronchoscopic Lung Volume Reduction
BLVR
TLVR
Pathologic Process
Lung Diseases
Respiratory Tract Disease

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 02, 2015