N/A N=93 Randomized Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT02025205 ↗

Enrolled (actual)

Serious AEs

47.3%

Results posted

Aug 2019

Primary outcome: Primary: Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population) — 13.7; -3.2 percent change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Endobronchial Valve (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pulmonx International Sàrl
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)	13.7; -3.2	—
SECONDARY Absolute Change in Target Lobe Volume for EBV Group (ITT Population)	1195	—
SECONDARY Percent Change in Target Lobe Volume for EBV Group (ITT Population)	64.9	—
SECONDARY Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months	32; 4	—
SECONDARY Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months	0.1; -0.02	—
SECONDARY Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months	3.4; -1.3	—
SECONDARY Absolute Change in Residual Volume (RV) at 3 Months	-0.4; 0.1	—
SECONDARY Percent Change in Residual Volume (RV) at 3 Months	-6.7; 2.7	—
SECONDARY Percent Predicted Change in Residual Volume at 3 Months	-21.1; -0.3	—
SECONDARY Absolute Change in Six-Minute Walk Distance at 3 Months	22.6; -17.3	—
SECONDARY Percent Change in Six-Minute Walk Distance at 3 Months	10.6; -3.9	—
SECONDARY Absolute Change in the SGRQ Total Score From Baseline to 3 Months	-8.6; 1.0	—
SECONDARY Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months	-14.8; 3.9	—
SECONDARY Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months	-0.4; 0.2	—
SECONDARY Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months	-11.0; 14.3	—
SECONDARY Absolute Change in the CAT Total Score From Baseline to 3 Months	-1.5; -0.7	—
SECONDARY Percent Change (%) in CAT Total Score From Baseline to 3 Months	-4.9; -0.9	—
SECONDARY Absolute Change in EQ-5D Summary Index From Baseline to 3 Months	0.1; 0.01	—
SECONDARY Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months	32.7; 26.2	—
SECONDARY Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months	12.7; -0.4	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02025205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.