A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema

Pulmonx International Sàrl8 sites in 3 countries93 target enrollmentAugust 2014

ConditionsCOPD Patients With Homogeneous Emphysema Endoscopic Lung Volume Reduction With Endobronchial Valve

Overview

Phase: N/A
Intervention: Not specified
Conditions: COPD Patients With Homogeneous Emphysema
Sponsor: Pulmonx International Sàrl
Enrollment: 93
Locations: 8
Primary Endpoint: Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

March 15, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pulmonx International Sàrl

Responsible Party

Sponsor

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
•Use of more than 25 mg/day prednisolone or equivalent

Outcomes

Primary Outcomes

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

Time Frame: At baseline and after 3 months

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

Secondary Outcomes

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)
Percent Change in Residual Volume (RV) at 3 Months(At baseline and after 3 months)
Absolute Change in Target Lobe Volume for EBV Group (ITT Population)(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)
Absolute Change in Residual Volume (RV) at 3 Months(At baseline and after 3 months)
Percent Predicted Change in Residual Volume at 3 Months(At baseline and after 3 months)
Absolute Change in Six-Minute Walk Distance at 3 Months(At baseline and after 3 months)
Percent Change in Six-Minute Walk Distance at 3 Months(At baseline and after 3 months)
Absolute Change in the SGRQ Total Score From Baseline to 3 Months(At baseline and after 3 months)
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months(At baseline and after 3 months)
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months(At baseline and after 3 months)
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months(At baseline and after 3 months)
Absolute Change in the CAT Total Score From Baseline to 3 Months(At baseline and after 3 months)
Percent Change (%) in CAT Total Score From Baseline to 3 Months(At baseline and after 3 months)
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months(At baseline and after 3 months)
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months(At baseline and after 3 months)
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months(At baseline and after 3 months)