Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Unilateral vs. Bilateral IBV Placement

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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Device: IBV Implantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Felix JF Herth, MD; Phone Number: 1200 +49 6221 396; Email: Felix.Herth@thoraxklinik-heidelberg.de
• Study Contact Backup: Name: Ralf Eberhardt, MD; Phone Number: 1204 +49 6221 396; Email: Ralf.Eberhardt@rthoraxklinik-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklinik Heidelberg
    • Contact: Felix JF Herth, MD; Phone Number: 1200 +49 6221 396; Email: Felix.Herth@thoraxklinik-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnant homogeneous disease FEV1 < 20%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Spiration IBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in pulmonary function (FEV1) 6-minute walking test	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of major complications(SAE)	3 months
Evaluation of the IBV migration rate	3 months
Average changes in quality of life (SGRQ)	3 months
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)	3 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: Spiration, Inc.
• Investigators: Principal Investigator: Felix JF Herth, MD, Heidelberg University

Publications and helpful links

General 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. doi: 10.1016/j.thorsurg.2009.04.002.
• Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. doi: 10.1513/pats.200809-114GO.
• Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. doi: 10.1513/pats.200707-085ET.
• Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Estimate): April 27, 2011
• Last Update Submitted That Met QC Criteria: April 26, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: COPD; emphysema; Endoscopic lung volume reduction; Patients with bilateral heterogeneous pulmonary emphysema
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 09 2009