Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Pulmonary Emphysema Clinical Trial

Official title:

Unilateral vs. Bilateral IBV Placement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00995852
• Other study ID #: 09 2009
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 14, 2009
• Last updated: April 26, 2011
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2009
• Source: Heidelberg University
• Contact: Felix JF Herth, MD
• Phone: +49 6221 396
• Email: Felix.Herth[@]thoraxklinik-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Thoraxklinik Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Spiration, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pulmonary function (FEV1) 6-minute walking test		3 months	No
Secondary	Number of major complications(SAE)		3 months	Yes
Secondary	Evaluation of the IBV migration rate		3 months	Yes
Secondary	Average changes in quality of life (SGRQ)		3 months	Yes
Secondary	Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)		3 months	Yes