Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

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.

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: InterVapor® treatment plus Optimal Medical Therapy; Other: Optimal Medical Therapy

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Vienna, Austria, 1140
    • Otto-Wagner-Spital
• Germany
  • Berlin, Germany, 10117
    • Charite Universitätsmedizin Berlin Campus Mitte
  • Berlin, Germany, 14089
    • Gemeinschaftskrankenhaus Havelhöhe Berlin
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken Gauting München
  • Gerlingen, Germany
    • Klinik Schillerhohe
  • Halle, Germany
    • Universitätsklinik Halle
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Nuernberg, Germany, 90419
    • Klinikum Nürnberg
• Ireland
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital
• New Zealand
  • Auckland, New Zealand, 1051
    • Auckland City Hospital
• United Kingdom
  • London, United Kingdom
    • Royal Bromptom & Harefield NHS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment plus Optimal Medical Therapy; Patients will be treated with the InterVapor System and Optimal Medical Therapy	Device: InterVapor® treatment plus Optimal Medical Therapy; 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).; Other Names: InterVapor or BTVA
Active Comparator: Optimal Medical Therapy; Patients will be treated according to Optimal Medical Therapy	Other: Optimal Medical Therapy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Forced expiratory volume in 1-second (FEV1) compared to active comparator	Year 1
Quality of Life (SGRQ)	Year 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Uptake Medical Corp
• Investigators: Principal Investigator: Felix JF Herth, MD, Heidelberg University; Principal Investigator: Gregory Snell, MD, The Alfred Hospital, Melbourne, Australia

Publications and helpful links

General Publications

• 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.
• Bandyopadhyay 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.
• Valipour 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; emphysema; treatments; InterVapor; lung volume reduction; endoscopic lung volume reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CSP-1570