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

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719263
• Other study ID #: CSP-1570
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: October 27, 2015
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Uptake Medical Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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:
• 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).

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Austria	Otto-Wagner-Spital	Vienna
Germany	Charite Universitätsmedizin Berlin Campus Mitte	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe Berlin	Berlin
Germany	Asklepios Fachkliniken Gauting München	Gauting
Germany	Klinik Schillerhohe	Gerlingen
Germany	Universitätsklinik Halle	Halle
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Klinikum Nürnberg	Nuernberg
Ireland	Mater Misericordiae University Hospital	Dublin
New Zealand	Auckland City Hospital	Auckland
United Kingdom	Royal Bromptom & Harefield NHS Foundation	London

Sponsors (1)

Lead Sponsor	Collaborator
Uptake Medical Corp

Countries where clinical trial is conducted

Australia,  Austria,  Germany,  Ireland,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1-second (FEV1) compared to active comparator		Year 1	No
Primary	Quality of Life (SGRQ)		Year 1	No
Secondary	Responder rate for FEV1 % difference from baseline		Year 1	No
Secondary	Responder rate SGRQ pts difference from baseline		Year 1	No
Secondary	Responder rate 6MWD meter difference from baseline		Year 1	No
Secondary	Lobar Volume Reduction HRCT		Year 1	No