Endobronchial Valve for Emphysema Palliation Trial (VENT)

NCT00129584 | Completed Phase 3

• 1 other identifier: 630-0001
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Keywords

Endobronchial Valve (EBV) Procedure; Bronchoscopic Lung Volume Reduction

Outcome Measures

Primary Outcomes (3)

• Pulmonary function testing at various time points through one year

• Exercise tolerance at various time points through one year

• Major complications at various time points through one year

Secondary Outcomes (3)

• Pulmonary function testing at various time points through one year

• Quality of life measures at various time points through one year

• Other adverse event rates at various time points through one year

Interventions

Emphasys Endobronchial Valve and procedure PROCEDURE

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emphasys Medical: lead

Related Publications (20)

• 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. doi: 10.1056/NEJMoa021322.

  PMID: 14999112 BACKGROUND

• 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. doi: 10.1056/NEJM199604253341704.

  PMID: 8598868 BACKGROUND

• 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. doi: 10.1164/ajrccm.155.6.9196106.

  PMID: 9196106 BACKGROUND

• 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.

  PMID: 9639013 BACKGROUND

• 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. doi: 10.1056/NEJM200007273430402.

  PMID: 10911005 BACKGROUND

• 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. doi: 10.1378/chest.116.6.1608.

  PMID: 10593784 BACKGROUND

• 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. doi: 10.1378/chest.117.4.991.

  PMID: 10767229 BACKGROUND

• 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. doi: 10.1034/j.1399-3003.1999.14a39.x.

  PMID: 10489857 BACKGROUND

• 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. doi: 10.1378/chest.118.5.1240.

  PMID: 11083670 BACKGROUND

• 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. doi: 10.1164/ajrccm.154.4.8887590.

  PMID: 8887590 BACKGROUND

• 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. doi: 10.1016/s1072-7515(97)00021-5.

  PMID: 9208957 BACKGROUND

• Hoppin FG Jr. Theoretical basis for improvement following reduction pneumoplasty in emphysema. Am J Respir Crit Care Med. 1997 Feb;155(2):520-5. doi: 10.1164/ajrccm.155.2.9032188.

  PMID: 9032188 BACKGROUND

• 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. doi: 10.1016/s0003-4975(98)01302-2.

  PMID: 10215234 BACKGROUND

• 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. doi: 10.2169/internalmedicine.39.381.

  PMID: 10830177 BACKGROUND

• 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. doi: 10.1056/NEJMoa030287. Epub 2003 May 20.

  PMID: 12759479 BACKGROUND

• 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. doi: 10.1016/S0140-6736(03)12762-6.

  PMID: 12648974 BACKGROUND

• Valipour A, Herth FJ, Burghuber OC, Criner G, Vergnon JM, Goldin J, Sciurba F, Ernst A; VENT Study Group. Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy. Eur Respir J. 2014 Feb;43(2):387-96. doi: 10.1183/09031936.00133012. Epub 2013 Jul 11.

  PMID: 23845721 DERIVED

• Herth FJ, Noppen M, Valipour A, Leroy S, Vergnon JM, Ficker JH, Egan JJ, Gasparini S, Agusti C, Holmes-Higgin D, Ernst A; International VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. 2012 Jun;39(6):1334-42. doi: 10.1183/09031936.00161611. Epub 2012 Jan 26.

  PMID: 22282552 DERIVED

• Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.

  PMID: 20860505 DERIVED

• Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.

  PMID: 17711594 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Frank C Sciurba, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 12, 2005
• Study Start: January 1, 2004
• Last Updated: August 18, 2009

Record last verified: 2009-08