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

Conditions

Emphysema

Keywords

emphysema, InterVapor, treatments, pulmonary rehabilitation, lung volume reduction, endoscopic lung volume reduction

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.

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.

2016-02-16105 citations

10.1016/s2213-2600(16)00045-x

Segmental approach to lung volume reduction therapy for emphysema patients.

Bandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ.

2014-12-0616 citations

10.1159/000369036

Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study.

Valipour A, Herth FJ, Eberhardt R, Shah PL, Gupta A, Barry R, Henne E, Bandyopadhyay S, Snell G.

2014-12-0314 citations

10.1186/1471-2466-14-190

Interventions

DEVICEInterVapor® 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).

OTHEROptimal 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed