Clinical trial NCT02025205: Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
Official title: A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Patients With Homogeneous Emphysema
Endoscopic Lung Volume Reduction With Endobronchial Valve
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 93
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.


Eligibility criteria: Inclusion Criteria:

* Homogeneous emphysema
* 15% ≤ FEV1 ≤ 45% predicted
* TLC \> 100% predicted
* RV ≥ 200% predicted
* 6MWT ≥ 150 m
* Non-smoker \> 8 weeks prior to study entry
* Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

* Active pulmonary infection
* More than 3 exacerbations with hospitalizations over the past 12 months
* Pulmonary hypertension (sPAP \> 45 mmHg)
* MI or other relevant CV events in the past 6 months
* Alpha-1 antitrypsin deficiency
* Bronchiectasis
* Prior LVR or LVRS procedure
* \> 20% difference in perfusion between right and left lung
* Hypercapnia (paCO2 \> 55 mmHg
* Asthma
* Use of more than 25 mg/day prednisolone or equivalent
* Severe bullous emphysema
* Systemic or malignant disease with high death probability within 12 months

Primary outcomes:
measure: Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
timeFrame: At baseline and after 3 months
Secondary outcomes:
measure: Absolute Change in Target Lobe Volume for EBV Group (ITT Population)
timeFrame: At baseline and after 3 months
measure: Percent Change in Target Lobe Volume for EBV Group (ITT Population)
timeFrame: At baseline and after 3 months
measure: Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in Residual Volume (RV) at 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change in Residual Volume (RV) at 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Predicted Change in Residual Volume at 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in Six-Minute Walk Distance at 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change in Six-Minute Walk Distance at 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in the SGRQ Total Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in the CAT Total Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change (%) in CAT Total Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in EQ-5D Summary Index From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months
timeFrame: At baseline and after 3 months
measure: Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months
timeFrame: At baseline and after 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum
city: Hamburg
country: Germany
facility: Lungenabteilung Thoraxzentrum Hamburg
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitäts klinikum Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Groningen
country: Netherlands
facility: Department of pulmonary dieases, University Medical Center
Study officials:
affiliation: Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria
name: Arschang Valipour, MD, PhD, FCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Felix Herth (co-principal investigator), MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Ralf Eberhardt (co-principal investigator), MD
role: PRINCIPAL_INVESTIGATOR
References: