Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study - Full Text View

Purpose

Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Condition	Intervention	Phase
Pulmonary Emphysema	Device: IBV Implantation	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Unilateral vs. Bilateral IBV Placement

Resource links provided by NLM:

MedlinePlus related topics: Emphysema Endoscopy

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Improvement in pulmonary function (FEV1) 6-minute walking test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of major complications(SAE) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Evaluation of the IBV migration rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Average changes in quality of life (SGRQ) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: bilateral Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use 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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration Other Name: Spiration IBV
Active Comparator: unilateral Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs	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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration Other Name: Spiration IBV

Arms

Assigned Interventions

Active Comparator: bilateral

Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral).

The study will only use 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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration

Other Name: Spiration IBV

Active Comparator: unilateral

Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs

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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration

Other Name: Spiration IBV

Detailed Description:

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m

Exclusion Criteria:

pregnant homogeneous disease FEV1 < 20%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995852

Contacts

Contact: Felix JF Herth, MD	+49 6221 396 ext 1200	Felix.Herth@thoraxklinik-heidelberg.de
Contact: Ralf Eberhardt, MD	+49 6221 396 ext 1204	Ralf.Eberhardt@rthoraxklinik-heidelberg.de

Locations

Germany
Thoraxklinik Heidelberg	Recruiting
Heidelberg, Germany, 69126
Contact: Felix JF Herth, MD +49 6221 396 ext 1200 Felix.Herth@thoraxklinik-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Spiration, Inc.

Investigators

Principal Investigator:

Felix JF Herth, MD

University of Heidelberg

More Information

Publications:

Venuta F, Rendina EA, Coloni GF. Endobronchial treatment of emphysema with one-way valves. Thorac Surg Clin. 2009 May;19(2):255-60, x. Review.

Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. Review.

Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):900-8.

Responsible Party:	Prof. Felix JF Herth, Thoraxklinik Heidelberg
ClinicalTrials.gov Identifier:	NCT00995852 History of Changes
Other Study ID Numbers:	09 2009
Study First Received:	October 14, 2009
Last Updated:	April 26, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

Endoscopic lung volume reduction
emphysema
COPD
Patients with bilateral heterogeneous pulmonary emphysema

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013