European Multi-center Post Market Study of the IBV Valve System (IBV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00880724
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Spiration, Inc.

Brief Summary:
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: IBV Valve

Detailed Description:
The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema
Study Start Date : March 2007
Primary Completion Date : December 2009
Study Completion Date : June 2010

Arm Intervention/treatment
No Intervention: Medical management Device: IBV Valve
Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
Other Names:
  • BLVR
  • Endoscopic Volume Reduction
  • Endobronchial Valve

Primary Outcome Measures :
  1. The difference between the response rates of the treatment and control groups. [ Time Frame: 3-months post randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between 40 and 74 years of age
  • Predominantly upper lobe emphysema and severe dyspnea
  • Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
  • Physical ability to participate in the study by performing a 6-minute walk distance of > 140m
  • No cigarette smoking for 4 months and willing to abstain throughout the study
  • Severe airflow obstruction defined by FEV1 45% of predicted
  • Severe hyperinflation defined by: TLC > 100% of predicted and RV > 150% of predicted

Exclusion Criteria:

  • Between 70 and 74 years of age and an FEV1 or DLCO < 20% of predicted
  • Severe gas exchange abnormalities
  • Major medical disease that will limit evaluation, participation or follow-up
  • Active asthma component to their disease
  • Giant bulla (> 1/3 volume of lung)
  • Severe pulmonary hypertension
  • Requirement for > 6L02 to keep saturation > 90% with exercise
  • Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00880724

Innsbruck, Austria
CHU Saint Pierre
Bruxelles, Belgium
Medizinische Hochschule Hannover
Hannover, Germany
Spedali Civili di Brescia
Brescia, Italy
Bellvitge Hospital
Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
United Kingdom
Royal Preston Hospital/Lancashire Teaching Hospitals
Preston, United Kingdom
Sponsors and Collaborators
Spiration, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Spiration, Inc. Identifier: NCT00880724     History of Changes
Other Study ID Numbers: CPR-01576 AD
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: June 2009

Keywords provided by Spiration, Inc.:
Bronchoscopic Treatment
Interventional Bronchoscopy

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