Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema - Full Text View

Purpose

Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Condition	Intervention	Phase
Pulmonary Emphysema	Device: EBV implantation Device: IBV implantation	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Heidelberg University:

Primary Outcome Measures:

Improvement in pulmonary function (FEV1 and RV/TLC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of severe adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Evaluation of valve migration rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Average changes in 6-minute-walk-distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	50
Study Start Date:	August 2011
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Endobronchial valves (EBV) Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves	Device: EBV implantation In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. Other Name: (Zephyr EBV)
Active Comparator: Intrabronchial valves (IBV) Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves	Device: IBV implantation In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. Other Name: (Spiration IBV)

Arms

Assigned Interventions

Active Comparator: Endobronchial valves (EBV)

Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves

Device: EBV implantation

In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Other Name: (Zephyr EBV)

Active Comparator: Intrabronchial valves (IBV)

Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves

Device: IBV implantation

In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Other Name: (Spiration IBV)

Detailed Description:

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility


Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
heterogeneous emphysema

Exclusion Criteria:

homogeneous emphysema
significant bronchiectasis
severe concomitant diseases
pregnancy

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: NCT01457833

Contacts


Contact: Daniela Gompelmann, MD	+49(0)62213968087	daniela.gompelmann@thoraxklinik-heidelberg.de
Contact: Felix JF Herth, MD	+49(0)62213961200	felix.herth@thoraxklinik-heidelberg.de

Locations


Germany
Thoraxklinik Heidelberg	Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD +49(0)62213968087 daniela.gompelmann@thoraxklinik-heidelberg.de
Principal Investigator: Daniela Gompelmann, MD

Sponsors and Collaborators

Heidelberg University

More Information

No publications provided


Responsible Party:	Felix JF Herth, Professor MD, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01457833 History of Changes
Other Study ID Numbers:	Protokoll E1.0-23.05.2011
Study First Received:	October 19, 2011
Last Updated:	October 21, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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 March 03, 2015