Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

NCT02025205 | Completed Results DMC

• 1 other identifier: 630-0014
• Study Type: interventional
• Target: 93
• Locations: 3 countries
• Sites: 8

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.

Conditions

COPD Patients With Homogeneous Emphysema; Endoscopic Lung Volume Reduction With Endobronchial Valve

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)

  Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.

  At baseline and after 3 months

Secondary Outcomes (19)

• Absolute Change in Target Lobe Volume for EBV Group (ITT Population)

  At baseline and after 3 months

• Percent Change in Target Lobe Volume for EBV Group (ITT Population)

  At baseline and after 3 months

• Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months

  At baseline and after 3 months

• Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months

  At baseline and after 3 months

• Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months

  At baseline and after 3 months

Study Arms (2)

ELVR with Endobronchial Valves

EXPERIMENTAL

Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Device: Endobronchial Valve

Standard of Care

NO INTERVENTION

Patients will receive optimal drug therapy and medical management according to clinical practice.

Interventions

Endobronchial Valve DEVICE

Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

ELVR with Endobronchial Valves

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmonx International Sàrl: lead

Study Sites (8)

Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie

Vienna, 1140, Austria

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum

Essen, 45239, Germany

Location

Lungenabteilung Thoraxzentrum Hamburg

Hamburg, 21075, Germany

Location

Thoraxklinik am Universitäts klinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

Department of pulmonary dieases, University Medical Center

Groningen, 9700RB, Netherlands

Location

Related Publications (1)

• Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.

  PMID: 39515624 DERIVED

Results Point of Contact

• Title: Narinder Shargill, Vice President, Global Medical and Clinical Affairs
• Organization: Pulmonx

nshargill@pulmonx.com

650-216-0108

Study Officials

• Arschang Valipour, MD, PhD, FCCP

  Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria

  PRINCIPAL INVESTIGATOR

• Felix Herth (co-principal investigator), MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Ralf Eberhardt (co-principal investigator), MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2013
• First Posted: December 31, 2013
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: March 15, 2017
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Locations

DE (6); NL (1); AU (1)