COPD Patients With Homogeneous EmphysemaIMPACTNCT02025205

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

A study testing Endobronchial Valve in people with COPD Patients With Homogeneous Emphysema and Endoscopic Lung Volume Reduction With Endobronchial Valve, run by Pulmonx International Sàrl at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD Patients With Homogeneous Emphysema, Endoscopic Lung Volume Reduction With Endobronchial Valve
What is being tested?: Endobronchial Valve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 8 sitesin 3 countries
Study dates: Aug 2014to 15 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Germany6 sites

Charité Campus Virchow-Klinikum
Berlin, 13353
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, 45239
Lungenabteilung Thoraxzentrum Hamburg
Hamburg, 21075
Thoraxklinik am Universitäts klinikum Heidelberg
Heidelberg, 69126
Lungenklinik Hemer
Hemer, 58675
Klinikum Nürnberg Nord
Nuremberg, 90419

Other trials in Germany

Austria1 site

Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
Vienna, 1140

Other trials in Austria

Netherlands1 site

Department of pulmonary dieases, University Medical Center
Groningen, 9700RB

Other trials in Netherlands

About this 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

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
Being tested: Endobronchial Valve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endobronchial ValveDevice
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Study groups in NCT02025205
Study group	Role	What they receive
ELVR with Endobronchial Valves	Experimental	Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve Receives: Device: Endobronchial Valve
Standard of Care	No intervention	Patients will receive optimal drug therapy and medical management according to clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline and after 3 months

Secondary outcomes (19)

Absolute Change in Target Lobe Volume for EBV Group (ITT Population)
Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Measured: At baseline and after 3 months
Percent Change in Target Lobe Volume for EBV Group (ITT Population)
Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Measured: 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
The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.
Measured: At baseline and after 3 months
Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months
The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups
Measured: At baseline and after 3 months
Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months
The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups
Measured: At baseline and after 3 months
Absolute Change in Residual Volume (RV) at 3 Months
Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Measured: At baseline and after 3 months
Percent Change in Residual Volume (RV) at 3 Months
Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Measured: At baseline and after 3 months
Percent Predicted Change in Residual Volume at 3 Months
Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups
Measured: At baseline and after 3 months
Absolute Change in Six-Minute Walk Distance at 3 Months
Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Measured: At baseline and after 3 months
Percent Change in Six-Minute Walk Distance at 3 Months
Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Measured: At baseline and after 3 months
Absolute Change in the SGRQ Total Score From Baseline to 3 Months
Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: At baseline and after 3 months
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months
Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group
Measured: At baseline and after 3 months
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months
Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Measured: At baseline and after 3 months
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months
Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Measured: At baseline and after 3 months
Absolute Change in the CAT Total Score From Baseline to 3 Months
Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group.
The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease.
Measured: At baseline and after 3 months
Percent Change (%) in CAT Total Score From Baseline to 3 Months
The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: At baseline and after 3 months
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months
Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state.
Measured: At baseline and after 3 months
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months
Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
Measured: At baseline and after 3 months
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months
Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome.
Measured: At baseline and after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201415 Mar 2017

First posted31 Dec 2013 (estimated)
Study startAug 2014
Primary completionApr 2016
Study completion15 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COPD Patients With Homogeneous EmphysemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02025205
Sponsor's protocol ID: 630-0014
Acronym: IMPACT
Status last verified: Jul 2019
First submitted: 21 Dec 2013
Last updated: 16 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 39515624

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
ClinicalTrials.gov ID: NCT02025205
Acronym / sponsor ID: IMPACT / 630-0014
Conditions: COPD Patients With Homogeneous Emphysema, Endoscopic Lung Volume Reduction With Endobronchial Valve
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Pulmonx International SàrlIndustry (pharma, biotech, devices)
Study start: Aug 2014 (actual)
Primary completion: Apr 2016 (actual)
Study completion: 15 Mar 2017 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Posted 16 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ELVR with Endobronchial Valves	Experimental	Device: Endobronchial ValveEndoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Standard of Care	No intervention	–Patients will receive optimal drug therapy and medical management according to clinical practice.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Homogeneous emphysema
15% ≤ FEV1 ≤ 45% predicted
TLC > 100% predicted
RV ≥ 200% predicted
6MWT ≥ 150 m

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endobronchial ValveEndoscopic Lung Volume Reduction with Zephyr Endobronchial Valve	Device	ELVR with Endobronchial Valves

Primary outcome

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.

19 secondary outcomes

Absolute Change in Target Lobe Volume for EBV Group (ITT Population)
Time frame: At baseline and after 3 months
Percent Change in Target Lobe Volume for EBV Group (ITT Population)
Time frame: 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
Time frame: At baseline and after 3 months
Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months
Time frame: At baseline and after 3 months
Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months
Time frame: At baseline and after 3 months
Absolute Change in Residual Volume (RV) at 3 Months
Time frame: At baseline and after 3 months
Percent Change in Residual Volume (RV) at 3 Months
Time frame: At baseline and after 3 months
Percent Predicted Change in Residual Volume at 3 Months
Time frame: At baseline and after 3 months
Absolute Change in Six-Minute Walk Distance at 3 Months
Time frame: At baseline and after 3 months
Percent Change in Six-Minute Walk Distance at 3 Months
Time frame: At baseline and after 3 months
Absolute Change in the SGRQ Total Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Absolute Change in the CAT Total Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Percent Change (%) in CAT Total Score From Baseline to 3 Months
Time frame: At baseline and after 3 months
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months
Time frame: At baseline and after 3 months
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months
Time frame: At baseline and after 3 months
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months
Time frame: At baseline and after 3 months

Results and safety

Results posted to the registry on 16 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BLVR With Zephyr Endobronchial Valves	43	40
Standard of Care	50	47

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

Time frame: At baseline and after 3 months. Mean (Standard Deviation). Unit: percent change

Measure	BLVR With Zephyr Endobronchial Valves n = 43	Standard of Care n = 50
Value	13.7 (28.2)	-3.2 (13)

Population analysed: ITT population

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BLVR With Zephyr Endobronchial Valves	28 of 43 (65.1%)	30 of 43 (69.8%)	Not reported
Standard of Care	16 of 50 (32%)	22 of 50 (44%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39515624Bakker 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arschang Valipour, MD, PhD, FCCP principal investigator

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

Felix Herth (co-principal investigator), MD principal investigator

Heidelberg University

Ralf Eberhardt (co-principal investigator), MD principal investigator

Heidelberg University

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population) (time frame: At baseline and after 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.