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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Spiration, Inc.
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT01812447
First received: March 7, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the IBV Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The IBV Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.


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

Study Type: Interventional
Study Design: Allocation: Randomized
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 IBV® 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:
  • Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with IBV 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: IBV 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.

  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 or > 35 kg/m2
  • Arterial Blood Gas Level (ABG) indicates:

    • PCO2 > 50 mm Hg
    • PO2 < 45 mm Hg on room air
  • Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
  • 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 23 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: April 22, 2014
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
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014