NCT00000606

Brief Summary

To evaluate the long term efficacy, morbidity and mortality associated with medical therapy with lung volume reduction surgery (LVRS) as compared to medical therapy alone and to define patient selection criteria. The trial, conducted in conjunction with a patient registry, is supported by the NHLBI, the Centers for Medicare and Medicaid Services (CMS), and the Agency for Healthcare Research and Quality (AHRQ).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1996

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2009

Enrollment Period

9 years

First QC Date

October 27, 1999

Last Update Submit

April 13, 2016

Conditions

EmphysemaLung DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease

Interventions

Lung volume reduction surgeryPROCEDURE

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Men and women with end-stage emphysema.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (25)

  • Rationale and design of the National Emphysema Treatment Trial (NETT): A prospective randomized trial of lung volume reduction surgery. J Thorac Cardiovasc Surg. 1999 Sep;118(3):518-28. doi: 10.1016/s0022-5223(99)70191-1. No abstract available.

    PMID: 10469970BACKGROUND

  • Rationale and design of The National Emphysema Treatment Trial: a prospective randomized trial of lung volume reduction surgery. The National Emphysema Treatment Trial Research Group. Chest. 1999 Dec;116(6):1750-61. doi: 10.1378/chest.116.6.1750.

    PMID: 10593802BACKGROUND

  • Ramsey SD, Sullivan SD, Kaplan RM, Wood DE, Chiang YP, Wagner JL. Economic analysis of lung volume reduction surgery as part of the National Emphysema Treatment Trial. NETT Research Group. Ann Thorac Surg. 2001 Mar;71(3):995-1002. doi: 10.1016/s0003-4975(00)02283-9.

    PMID: 11269488BACKGROUND

  • Drazen JM. Surgery for emphysema--not for everyone. N Engl J Med. 2001 Oct 11;345(15):1126-8. doi: 10.1056/NEJM200110113451511. No abstract available.

    PMID: 11596594BACKGROUND

  • National Emphysema Treatment Trial Research Group; Fishman A, Fessler H, Martinez F, McKenna RJ Jr, Naunheim K, Piantadosi S, Weinmann G, Wise R. Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med. 2001 Oct 11;345(15):1075-83. doi: 10.1056/NEJMoa11798.

    PMID: 11596586BACKGROUND

  • Rationale and design of the national emphysema treatment trial. A prospective randomized trial of lung volume reduction surgery. The national emphysema treatment trial research group. J Cardiopulm Rehabil. 2000 Jan;20(1):24-36. doi: 10.1097/00008483-200001000-00005.

    PMID: 10680095BACKGROUND

  • Scharf SM, Iqbal M, Keller C, Criner G, Lee S, Fessler HE; National Emphysema Treatment Trial (NETT) Group. Hemodynamic characterization of patients with severe emphysema. Am J Respir Crit Care Med. 2002 Aug 1;166(3):314-22. doi: 10.1164/rccm.2107027.

    PMID: 12153963BACKGROUND

  • Ramsey SD, Berry K, Etzioni R, Kaplan RM, Sullivan SD, Wood DE; National Emphysema Treatment Trial Research Group. Cost effectiveness of lung-volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003 May 22;348(21):2092-102. doi: 10.1056/NEJMsa030448. Epub 2003 May 20.

    PMID: 12759480BACKGROUND

  • 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: 12759479BACKGROUND

  • Ware JH. The National Emphysema Treatment Trial--how strong is the evidence? N Engl J Med. 2003 May 22;348(21):2055-6. doi: 10.1056/NEJMp030068. Epub 2003 May 20. No abstract available.

    PMID: 12759478BACKGROUND

  • Drazen JM, Epstein AM. Guidance concerning surgery for emphysema. N Engl J Med. 2003 May 22;348(21):2134-6. doi: 10.1056/NEJMe030058. Epub 2003 May 20. No abstract available.

    PMID: 12759481BACKGROUND

  • Sciurba F, Criner GJ, Lee SM, Mohsenifar Z, Shade D, Slivka W, Wise RA; National Emphysema Treatment Trial Research Group. Six-minute walk distance in chronic obstructive pulmonary disease: reproducibility and effect of walking course layout and length. Am J Respir Crit Care Med. 2003 Jun 1;167(11):1522-7. doi: 10.1164/rccm.200203-166OC. Epub 2003 Feb 20.

    PMID: 12615634BACKGROUND

  • McKenna RJ Jr, Benditt JO, DeCamp M, Deschamps C, Kaiser L, Lee SM, Mohsenifar Z, Piantadosi S, Ramsey S, Reilly J, Utz J; National Emphysema Treatment Trial Research Group. Safety and efficacy of median sternotomy versus video-assisted thoracic surgery for lung volume reduction surgery. J Thorac Cardiovasc Surg. 2004 May;127(5):1350-60. doi: 10.1016/j.jtcvs.2003.11.025.

    PMID: 15115992BACKGROUND

  • Kaplan RM, Ries AL, Reilly J, Mohsenifar Z; National Emphysema Treatment Trial Research Group. Measurement of health-related quality of life in the national emphysema treatment trial. Chest. 2004 Sep;126(3):781-9. doi: 10.1378/chest.126.3.781.

    PMID: 15364757BACKGROUND

  • Kaplan RM, Sun Q, Ries AL. Quality of well-being outcomes in the National Emphysema Treatment Trial. Chest. 2015 Feb;147(2):377-387. doi: 10.1378/chest.14-0528.

    PMID: 25340383DERIVED

  • Kaplan RM, Sun Q, Naunheim KS, Ries AL. Long-term follow-up of high-risk patients in the National Emphysema Treatment Trial. Ann Thorac Surg. 2014 Nov;98(5):1782-9. doi: 10.1016/j.athoracsur.2014.06.031. Epub 2014 Sep 4.

    PMID: 25201722DERIVED

  • Argula RG, Strange C, Ramakrishnan V, Goldin J. Baseline regional perfusion impacts exercise response to endobronchial valve therapy in advanced pulmonary emphysema. Chest. 2013 Nov;144(5):1578-1586. doi: 10.1378/chest.12-2826.

    PMID: 23828481DERIVED

  • Giardino ND, Curtis JL, Andrei AC, Fan VS, Benditt JO, Lyubkin M, Naunheim K, Criner G, Make B, Wise RA, Murray SK, Fishman AP, Sciurba FC, Liberzon I, Martinez FJ; NETT Research Group. Anxiety is associated with diminished exercise performance and quality of life in severe emphysema: a cross-sectional study. Respir Res. 2010 Mar 9;11(1):29. doi: 10.1186/1465-9921-11-29.

    PMID: 20214820DERIVED

  • Hunninghake GM, Cho MH, Tesfaigzi Y, Soto-Quiros ME, Avila L, Lasky-Su J, Stidley C, Melen E, Soderhall C, Hallberg J, Kull I, Kere J, Svartengren M, Pershagen G, Wickman M, Lange C, Demeo DL, Hersh CP, Klanderman BJ, Raby BA, Sparrow D, Shapiro SD, Silverman EK, Litonjua AA, Weiss ST, Celedon JC. MMP12, lung function, and COPD in high-risk populations. N Engl J Med. 2009 Dec 31;361(27):2599-608. doi: 10.1056/NEJMoa0904006. Epub 2009 Dec 16.

    PMID: 20018959DERIVED

  • Moy ML, Reilly JJ, Ries AL, Mosenifar Z, Kaplan RM, Lew R, Garshick E; National Emphysema Treatment Trial Research Group. Multivariate models of determinants of health-related quality of life in severe chronic obstructive pulmonary disease. J Rehabil Res Dev. 2009;46(5):643-54. doi: 10.1682/jrrd.2008.09.0127.

    PMID: 19882497DERIVED

  • Drummond MB, Blackford AL, Benditt JO, Make BJ, Sciurba FC, McCormack MC, Martinez FJ, Fessler HE, Fishman AP, Wise RA; NETT Investigators. Continuous oxygen use in nonhypoxemic emphysema patients identifies a high-risk subset of patients: retrospective analysis of the National Emphysema Treatment Trial. Chest. 2008 Sep;134(3):497-506. doi: 10.1378/chest.08-0117. Epub 2008 Jul 18.

    PMID: 18641094DERIVED

  • Martinez FJ, Han MK, Andrei AC, Wise R, Murray S, Curtis JL, Sternberg A, Criner G, Gay SE, Reilly J, Make B, Ries AL, Sciurba F, Weinmann G, Mosenifar Z, DeCamp M, Fishman AP, Celli BR; National Emphysema Treatment Trial Research Group. Longitudinal change in the BODE index predicts mortality in severe emphysema. Am J Respir Crit Care Med. 2008 Sep 1;178(5):491-9. doi: 10.1164/rccm.200709-1383OC. Epub 2008 Jun 5.

    PMID: 18535255DERIVED

  • Snyder ML, Goss CH, Neradilek B, Polissar NL, Mosenifar Z, Wise RA, Fishman AP, Benditt JO; National Emphysema Treatment Trial Research Group. Changes in arterial oxygenation and self-reported oxygen use after lung volume reduction surgery. Am J Respir Crit Care Med. 2008 Aug 15;178(4):339-45. doi: 10.1164/rccm.200712-1826OC. Epub 2008 Jun 5.

    PMID: 18535254DERIVED

  • Washko GR, Fan VS, Ramsey SD, Mohsenifar Z, Martinez F, Make BJ, Sciurba FC, Criner GJ, Minai O, Decamp MM, Reilly JJ; National Emphysema Treatment Trial Research Group. The effect of lung volume reduction surgery on chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Jan 15;177(2):164-9. doi: 10.1164/rccm.200708-1194OC. Epub 2007 Oct 25.

    PMID: 17962632DERIVED

  • Falk JA, Martin UJ, Scharf S, Criner GJ. Lung elastic recoil does not correlate with pulmonary hemodynamics in severe emphysema. Chest. 2007 Nov;132(5):1476-84. doi: 10.1378/chest.07-0041. Epub 2007 Oct 1.

    PMID: 17908710DERIVED

MeSH Terms

Conditions

EmphysemaLung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Steven Piantadosi

    Johns Hopkins University

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

December 1, 1996

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 14, 2016

Record last verified: 2009-04