Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Endobronchial Valve for Emphysema Palliation Trial (VENT)
NCT number | NCT00129584 |
Other study ID # | 630-0001 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | August 10, 2005 |
Last updated | August 14, 2009 |
Start date | January 2004 |
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 |
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Emphasys Medical |
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
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 |
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