Endobronchial Valve for Emphysema Palliation Trial (VENT)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Endobronchial Valve for Emphysema Palliation Trial (VENT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129584
• Other study ID #: 630-0001
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2005
• Last updated: August 14, 2009
• Start date: January 2004

Study information

• Verified date: August 2009
• Source: Emphasys Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.

Description:

Background:

Emphysema, caused primarily by smoking, is characterized by the gradual, irreversible breakdown of tissue and loss of elastic recoil within the lungs, causing them to lose the ability to expel air and efficiently absorb oxygen. As this chronic condition inexorably progresses, the diseased, hyperinflated areas of the lung eventually fill the chest cavity, leaving less and less volume available for the viable lung tissue.

Lung volume reduction surgery (LVRS) has been shown to offer relief to patients suffering from emphysema when other treatment options fail. Researchers have continued to refine both technique and patient selection in order to improve outcomes. The objective of lung volume reduction is to eliminate dysfunctional, over-inflated regions of lung. Results similar to surgical removal have been obtained by plication (folding) and stapling without tissue removal. These results suggest that isolation of the dysfunctional lung region can achieve similar results to tissue removal.

The paradoxical effect of improving lung function by removing (or isolating) lung tissue demonstrates that breathlessness due to emphysema is a function of mechanical inefficiencies in addition to loss of gas-transfer surface area and other physiological mechanisms. At least in some patients, the mechanical compromise is the primary cause of their pulmonary incapacitation and these patients can benefit by addressing their inability to effectively inhale and exhale. Because LVRS reduces trapped gas, others have speculated that results similar to LVRS could be achieved bronchoscopically by reducing the volume of the hyperinflated regions with, or without, atelectasis.

Emphasys has developed a bronchoscopic approach to block inspiratory airflow into targeted, hyperinflated regions of the lung, while permitting exhaled gas to escape. This approach may lead to lung volume reduction and provide some of the clinical benefits of LVRS without the high risks and costs associated with such an invasive surgical procedure.

Comparison:

The primary object of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution

• Forced expiratory volume in 1 second (FEV1) < 45% predicted

• Total lung capacity (TLC) > 100% predicted

• Residual volume (RV) > 150% predicted

• Post rehabilitation 6 minute walk test > 140m

• Non-smoking for 4 months

Exclusion Criteria:

• Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy

• History of recurrent respiratory infections

• Evidence of large bullae (>30% of either lung) in a non-target lobe

• FEV1 < 15% predicted

• Diffusing capacity for carbon monoxide (DLCO) < 20% predicted

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Procedure:
• Emphasys Endobronchial Valve and procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emphasys Medical

References & Publications (16)

Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. — View Citation

Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, Weinmann G, Wood DE; National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003 May 22;348(21):2059-73. Epub 2003 May 20. — View Citation

Geddes D, Davies M, Koyama H, Hansell D, Pastorino U, Pepper J, Agent P, Cullinan P, MacNeill SJ, Goldstraw P. Effect of lung-volume-reduction surgery in patients with severe emphysema. N Engl J Med. 2000 Jul 27;343(4):239-45. — View Citation

Gelb AF, McKenna RJ Jr, Brenner M, Schein MJ, Zamel N, Fischel R. Lung function 4 years after lung volume reduction surgery for emphysema. Chest. 1999 Dec;116(6):1608-15. — View Citation

Gelb AF, Zamel N, McKenna RJ Jr, Brenner M. Mechanism of short-term improvement in lung function after emphysema resection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):945-51. — View Citation

Gierada DS, Yusen RD, Villanueva IA, Pilgram TK, Slone RM, Lefrak SS, Cooper JD. Patient selection for lung volume reduction surgery: An objective model based on prior clinical decisions and quantitative CT analysis. Chest. 2000 Apr;117(4):991-8. — View Citation

Hoppin FG Jr. Theoretical basis for improvement following reduction pneumoplasty in emphysema. Am J Respir Crit Care Med. 1997 Feb;155(2):520-5. — View Citation

Iwasaki M, Nishiumi N, Kaga K, Kanazawa M, Kuwahira I, Inoue H. Application of the fold plication method for unilateral lung volume reduction in pulmonary emphysema. Ann Thorac Surg. 1999 Mar;67(3):815-7. — View Citation

Kuwahira I, Iwasaki M, Kaga K, Iwamoto T, Tazaki G, Ishii M, Inoue H, Ohta Y. Effectiveness of the fold plication method in lung volume reduction surgery. Intern Med. 2000 May;39(5):381-4. — View Citation

Martinez FJ, de Oca MM, Whyte RI, Stetz J, Gay SE, Celli BR. Lung-volume reduction improves dyspnea, dynamic hyperinflation, and respiratory muscle function. Am J Respir Crit Care Med. 1997 Jun;155(6):1984-90. — View Citation

Rogers RM, Coxson HO, Sciurba FC, Keenan RJ, Whittall KP, Hogg JC. Preoperative severity of emphysema predictive of improvement after lung volume reduction surgery: use of CT morphometry. Chest. 2000 Nov;118(5):1240-7. — View Citation

Russi EW, Bloch KE, Weder W. Functional and morphological heterogeneity of emphysema and its implication for selection of patients for lung volume reduction surgery. Eur Respir J. 1999 Jul;14(1):230-6. Review. — View Citation

Sabanathan A, Sabanathan S, Shah R, Richardson J. Lung volume reduction surgery for emphysema. A review. J Cardiovasc Surg (Torino). 1998 Apr;39(2):237-43. Review. — View Citation

Sciurba FC, Rogers RM, Keenan RJ, Slivka WA, Gorcsan J 3rd, Ferson PF, Holbert JM, Brown ML, Landreneau RJ. Improvement in pulmonary function and elastic recoil after lung-reduction surgery for diffuse emphysema. N Engl J Med. 1996 Apr 25;334(17):1095-9. — View Citation

Swanson SJ, Mentzer SJ, DeCamp MM Jr, Bueno R, Richards WG, Ingenito EP, Reilly JJ, Sugarbaker DJ. No-cut thoracoscopic lung plication: a new technique for lung volume reduction surgery. J Am Coll Surg. 1997 Jul;185(1):25-32. — View Citation

Toma TP, Hopkinson NS, Hillier J, Hansell DM, Morgan C, Goldstraw PG, Polkey MI, Geddes DM. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet. 2003 Mar 15;361(9361):931-3. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function testing at various time points through one year
Primary	Exercise tolerance at various time points through one year
Primary	Major complications at various time points through one year
Secondary	Pulmonary function testing at various time points through one year
Secondary	Quality of life measures at various time points through one year
Secondary	Other adverse event rates at various time points through one year