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

Primary Purpose

Emphysema

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InterVapor® treatment plus Optimal Medical Therapy
Optimal Medical Therapy
Sponsored by
Uptake Medical Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring emphysema, InterVapor, treatments, pulmonary rehabilitation, lung volume reduction, endoscopic lung volume reduction

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince Charles Hospital
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Otto-Wagner-Spital
  • Charite Universitätsmedizin Berlin Campus Mitte
  • Gemeinschaftskrankenhaus Havelhöhe Berlin
  • Asklepios Fachkliniken Gauting München
  • Klinik Schillerhohe
  • Universitätsklinik Halle
  • Asklepios Klinik Harburg
  • Thoraxklinik Heidelberg
  • Lungenklinik Hemer
  • Klinikum Nürnberg
  • Mater Misericordiae University Hospital
  • Auckland City Hospital
  • Royal Bromptom & Harefield NHS Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment plus Optimal Medical Therapy

Optimal Medical Therapy

Arm Description

Patients will be treated with the InterVapor System and Optimal Medical Therapy

Patients will be treated according to Optimal Medical Therapy

Outcomes

Primary Outcome Measures

Forced expiratory volume in 1-second (FEV1) compared to active comparator
Quality of Life (SGRQ)

Secondary Outcome Measures

Responder rate for FEV1 % difference from baseline
Responder rate SGRQ pts difference from baseline
Responder rate 6MWD meter difference from baseline
Lobar Volume Reduction HRCT

Full Information

First Posted
October 26, 2012
Last Updated
October 27, 2015
Sponsor
Uptake Medical Corp
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1. Study Identification

Unique Protocol Identification Number
NCT01719263
Brief Title
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Official Title
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptake Medical Corp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
emphysema, InterVapor, treatments, pulmonary rehabilitation, lung volume reduction, endoscopic lung volume reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment plus Optimal Medical Therapy
Arm Type
Experimental
Arm Description
Patients will be treated with the InterVapor System and Optimal Medical Therapy
Arm Title
Optimal Medical Therapy
Arm Type
Active Comparator
Arm Description
Patients will be treated according to Optimal Medical Therapy
Intervention Type
Device
Intervention Name(s)
InterVapor® treatment plus Optimal Medical Therapy
Other Intervention Name(s)
InterVapor or BTVA
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Optimal Medical Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1-second (FEV1) compared to active comparator
Time Frame
Year 1
Title
Quality of Life (SGRQ)
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Responder rate for FEV1 % difference from baseline
Time Frame
Year 1
Title
Responder rate SGRQ pts difference from baseline
Time Frame
Year 1
Title
Responder rate 6MWD meter difference from baseline
Time Frame
Year 1
Title
Lobar Volume Reduction HRCT
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Snell, MD
Organizational Affiliation
The Alfred Hospital, Melbourne, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Otto-Wagner-Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Charite Universitätsmedizin Berlin Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Gemeinschaftskrankenhaus Havelhöhe Berlin
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Asklepios Fachkliniken Gauting München
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Klinik Schillerhohe
City
Gerlingen
Country
Germany
Facility Name
Universitätsklinik Halle
City
Halle
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Royal Bromptom & Harefield NHS Foundation
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26899390
Citation
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.
Results Reference
derived
PubMed Identifier
25500669
Citation
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.
Results Reference
derived
PubMed Identifier
25467378
Citation
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.
Results Reference
derived

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

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