Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study (IMPACT)
Primary Purpose
COPD Patients With Homogeneous Emphysema, Endoscopic Lung Volume Reduction With Endobronchial Valve
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endobronchial Valve
Sponsored by
About this trial
This is an interventional treatment trial for COPD Patients With Homogeneous Emphysema
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
Sites / Locations
- Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
- Charité Campus Virchow-Klinikum
- Ruhrlandklinik, Westdeutsches Lungenzentrum
- Lungenabteilung Thoraxzentrum Hamburg
- Thoraxklinik am Universitäts klinikum Heidelberg
- Lungenklinik Hemer
- Klinikum Nürnberg Nord
- Department of pulmonary dieases, University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ELVR with Endobronchial Valves
Standard of Care
Arm Description
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Patients will receive optimal drug therapy and medical management according to clinical practice.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
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
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
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
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
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
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.
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
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02025205
First Posted
December 21, 2013
Last Updated
July 9, 2019
Sponsor
Pulmonx International Sàrl
1. Study Identification
Unique Protocol Identification Number
NCT02025205
Brief Title
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
Acronym
IMPACT
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmonx International Sàrl
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Patients With Homogeneous Emphysema, Endoscopic Lung Volume Reduction With Endobronchial Valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELVR with Endobronchial Valves
Arm Type
Experimental
Arm Description
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients will receive optimal drug therapy and medical management according to clinical practice.
Intervention Type
Device
Intervention Name(s)
Endobronchial Valve
Intervention Description
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Primary Outcome Measure Information:
Title
Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)
Description
Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.
Time Frame
At baseline and after 3 months
Secondary Outcome Measure Information:
Title
Absolute Change in Target Lobe Volume for EBV Group (ITT Population)
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent Change in Target Lobe Volume for EBV Group (ITT Population)
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months
Description
The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.
Time Frame
At baseline and after 3 months
Title
Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months
Description
The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups
Time Frame
At baseline and after 3 months
Title
Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months
Description
The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups
Time Frame
At baseline and after 3 months
Title
Absolute Change in Residual Volume (RV) at 3 Months
Description
Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Time Frame
At baseline and after 3 months
Title
Percent Change in Residual Volume (RV) at 3 Months
Description
Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Time Frame
At baseline and after 3 months
Title
Percent Predicted Change in Residual Volume at 3 Months
Description
Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups
Time Frame
At baseline and after 3 months
Title
Absolute Change in Six-Minute Walk Distance at 3 Months
Description
Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Time Frame
At baseline and after 3 months
Title
Percent Change in Six-Minute Walk Distance at 3 Months
Description
Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Time Frame
At baseline and after 3 months
Title
Absolute Change in the SGRQ Total Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months
Description
Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group
Time Frame
At baseline and after 3 months
Title
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Absolute Change in the CAT Total Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent Change (%) in CAT Total Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
Title
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months
Description
Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
Time Frame
At baseline and after 3 months
Title
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months
Description
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.
Time Frame
At baseline and after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arschang Valipour, MD, PhD, FCCP
Organizational Affiliation
Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Herth (co-principal investigator), MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt (co-principal investigator), MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Lungenabteilung Thoraxzentrum Hamburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Thoraxklinik am Universitäts klinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Department of pulmonary dieases, University Medical Center
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
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