Clinical trial NCT01719263: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Keywords: emphysema
InterVapor
treatments
pulmonary rehabilitation
lung volume reduction
endoscopic lung volume reduction
Lead sponsor: Uptake Medical Corp
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 69
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Forced expiratory volume in 1-second (FEV1) compared to active comparator
timeFrame: Year 1
measure: Quality of Life (SGRQ)
timeFrame: Year 1
Secondary outcomes:
measure: Responder rate for FEV1 % difference from baseline
timeFrame: Year 1
measure: Responder rate SGRQ pts difference from baseline
timeFrame: Year 1
measure: Responder rate 6MWD meter difference from baseline
timeFrame: Year 1
measure: Lobar Volume Reduction HRCT
timeFrame: Year 1
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Vienna
country: Austria
facility: Otto-Wagner-Spital
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Mitte
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe Berlin
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Gauting München
city: Gerlingen
country: Germany
facility: Klinik Schillerhohe
city: Halle
country: Germany
facility: Universitätsklinik Halle
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Nuernberg
country: Germany
facility: Klinikum Nürnberg
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: London
country: United Kingdom
facility: Royal Bromptom & Harefield NHS Foundation
Study officials:
affiliation: Heidelberg University
name: Felix JF Herth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred Hospital, Melbourne, Australia
name: Gregory Snell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.