Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
1 other identifier
interventional
69
5 countries
13
Brief Summary
This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 29, 2015
October 1, 2015
2.3 years
October 26, 2012
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Forced expiratory volume in 1-second (FEV1) compared to active comparator
Year 1
Quality of Life (SGRQ)
Year 1
Secondary Outcomes (4)
Responder rate for FEV1 % difference from baseline
Year 1
Responder rate SGRQ pts difference from baseline
Year 1
Responder rate 6MWD meter difference from baseline
Year 1
Lobar Volume Reduction HRCT
Year 1
Study Arms (2)
Treatment plus Optimal Medical Therapy
EXPERIMENTALPatients will be treated with the InterVapor System and Optimal Medical Therapy
Optimal Medical Therapy
ACTIVE COMPARATORPatients will be treated according to Optimal Medical Therapy
Interventions
Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Eligibility Criteria
You may qualify if:
- Heterogeneous emphysema with upper lobe predominance in both lungs
- FEV1 between 20% and 45% predicted
- Residual volume (RV) \> 150% predicted
- Post-rehabilitation 6-minute walk test \> 140 meters
You may not qualify if:
- More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
- FEV1 \< 20% predicted
- DLCO \< 20% predicted or immeasurable DLCO
- Body mass index (BMI) \< 18kg/m2 or \> 32 kg/m2
- History of any of the following:
- Left ventricular ejection fraction (EF) ≤ 40%
- Stroke
- Myocardial infarction or acute coronary syndrome in previous year
- Hospitalization due to left ventricular failure in previous 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Otto-Wagner-Spital
Vienna, 1140, Austria
Charite Universitätsmedizin Berlin Campus Mitte
Berlin, 10117, Germany
Gemeinschaftskrankenhaus Havelhöhe Berlin
Berlin, 14089, Germany
Asklepios Fachkliniken Gauting München
Gauting, 82131, Germany
Klinik Schillerhohe
Gerlingen, Germany
Universitätsklinik Halle
Halle, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Thoraxklinik Heidelberg
Heidelberg, 69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Mater Misericordiae University Hospital
Dublin, 7, Ireland
Auckland City Hospital
Auckland, 1051, New Zealand
Royal Bromptom & Harefield NHS Foundation
London, United Kingdom
Related Publications (3)
Herth FJ, Valipour A, Shah PL, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, McNulty WH, Petermann C, Snell G, Gompelmann D. Segmental volume reduction using thermal vapour ablation in patients with severe emphysema: 6-month results of the multicentre, parallel-group, open-label, randomised controlled STEP-UP trial. Lancet Respir Med. 2016 Mar;4(3):185-93. doi: 10.1016/S2213-2600(16)00045-X. Epub 2016 Feb 16.
PMID: 26899390DERIVEDBandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ. Segmental approach to lung volume reduction therapy for emphysema patients. Respiration. 2015;89(1):76-81. doi: 10.1159/000369036. Epub 2014 Dec 6.
PMID: 25500669DERIVEDValipour A, Herth FJ, Eberhardt R, Shah PL, Gupta A, Barry R, Henne E, Bandyopadhyay S, Snell G. Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study. BMC Pulm Med. 2014 Dec 3;14:190. doi: 10.1186/1471-2466-14-190.
PMID: 25467378DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix JF Herth, MD
Heidelberg University
- PRINCIPAL INVESTIGATOR
Gregory Snell, MD
The Alfred Hospital, Melbourne, Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2012
First Posted
November 1, 2012
Study Start
June 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 29, 2015
Record last verified: 2015-10