An interventional study of Endobronchial Valve in COPD Patients With Homogeneous Emphysema and Endoscopic Lung Volume Reduction With Endobronchial Valve, sponsored by Pulmonx International Sàrl. Completed at 8 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-08-16.
Sponsored by Pulmonx International Sàrl · Not applicable, Interventional, and Treatment
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 93 is above the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Pulmonx International Sàrl is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Device: Endobronchial Valve
Patients will receive optimal drug therapy and medical management according to clinical practice.
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
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.
Time frame: At baseline and after 3 months
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.
Time frame: 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.
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and after 3 months
| Milestone | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Started | 43 | 50 |
| Completed | 40 | 47 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Death | 0 | 1 |
Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.
| percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population) | 13.7 ± 28.2 | -3.2 ± 13 |
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.
| mL | BLVR With Zephyr Endobronchial Valves |
|---|---|
| Absolute Change in Target Lobe Volume for EBV Group (ITT Population) | 1195 ± 683.2 |
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 | BLVR With Zephyr Endobronchial Valves |
|---|---|
| Percent Change in Target Lobe Volume for EBV Group (ITT Population) | 64.9 ± 32.5 |
The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.
| Participants | BLVR With Zephyr Endobronchial Valves |
|---|---|
| Yes | 32 |
| No | 4 |
The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups
| liters | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months | 0.1 ± 0.2 | -0.02 ± 0.1 |
The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups
| Percent predicted | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months | 3.4 ± 6.5 | -1.3 ± 4.2 |
Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
| liters | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in Residual Volume (RV) at 3 Months | -0.4 ± 0.9 | 0.1 ± 0.9 |
Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
| Percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change in Residual Volume (RV) at 3 Months | -6.7 ± 13.6 | 2.7 ± 19.0 |
Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups
| Percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Predicted Change in Residual Volume at 3 Months | -21.1 ± 47.6 | -0.3 ± 53.6 |
Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
| meters | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in Six-Minute Walk Distance at 3 Months | 22.6 ± 66.6 | -17.3 ± 52.8 |
Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
| Percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change in Six-Minute Walk Distance at 3 Months | 10.6 ± 26.5 | -3.9 ± 18.0 |
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.
| points on a scale | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in the SGRQ Total Score From Baseline to 3 Months | -8.6 ± 11.3 | 1.0 ± 9.4 |
Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group
| percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months | -14.8 ± 19.5 | 3.9 ± 20.5 |
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.
| points on a scale | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months | -0.4 ± 1.0 | 0.2 ± 1.0 |
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.
| Percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months | -11.0 ± 40.0 | 14.3 ± 59.3 |
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.
| points on a scale | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in the CAT Total Score From Baseline to 3 Months | -1.5 ± 5.6 | -0.7 ± 3.7 |
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.
| percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change (%) in CAT Total Score From Baseline to 3 Months | -4.9 ± 30.2 | -0.9 ± 16.5 |
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.
| points on a scale | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in EQ-5D Summary Index From Baseline to 3 Months | 0.1 ± 0.2 | 0.01 ± 0.2 |
Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
| percent change | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months | 32.7 ± 70.1 | 26.2 ± 115.0 |
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.
| points on a scale | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months | 12.7 ± 17.7 | -0.4 ± 17.6 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BLVR With Zephyr Endobronchial Valves | — | 28/43 (65.1%) | 30/43 (69.8%) |
| Standard of Care | — | 16/50 (32%) | 22/50 (44%) |
| Event | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| COPD ExacerbationRespiratory, thoracic and mediastinal disorders | 13/43 | 12/50 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 11/43 | 0/50 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/43 | 0/50 |
| HypercapniaRespiratory, thoracic and mediastinal disorders | 0/43 | 3/50 |
| Diagnostic bronchoscopyRespiratory, thoracic and mediastinal disorders | 2/43 | 0/50 |
| PneumoniaInfections and infestations | 0/43 | 2/50 |
| Event | BLVR With Zephyr Endobronchial Valves | Standard of Care |
|---|---|---|
| COPD ExacerbationRespiratory, thoracic and mediastinal disorders | 14/43 | 10/50 |
| Common coldRespiratory, thoracic and mediastinal disorders | 6/43 | 6/50 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/43 | 0/50 |
| Thoracic painRespiratory, thoracic and mediastinal disorders | 4/43 | 0/50 |
| DiarrheaGastrointestinal disorders | 3/43 | 0/50 |
| Urinary tract infectionInfections and infestations | 3/43 | 0/50 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/43 | 0/50 |
| Pulmonary infectionInfections and infestations | 3/43 | 0/50 |
| Pulmonary lesionRespiratory, thoracic and mediastinal disorders | 0/43 | 3/50 |
| Back painMusculoskeletal and connective tissue disorders | 2/43 | 0/50 |
| Age, Continuous(years) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Mean | 64.3 ± 6.3 | 63.2 ± 6.0 | 63.7 ± 6.1 |
| Sex: Female, Male(Participants) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Female | 23 | 34 | 57 |
| Male | 20 | 16 | 36 |
| Region of Enrollment(participants) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Netherlands | 9 | 14 | 23 |
| Austria | 8 | 13 | 21 |
| Germany | 26 | 23 | 49 |
| Height(cm) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Mean | 168.7 ± 10.0 | 165.4 ± 9.1 | 166.9 ± 9.6 |
| Weight(kg) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Mean | 67.9 ± 15.4 | 62.2 ± 12 | 64.8 ± 13.9 |
| BMI(kg/m^2) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Mean | 23.7 ± 4.3 | 22.6 ± 3.7 | 23.1 ± 4.0 |
| Pack Years Smoking History(pack-years) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Median | 41.5 ± 19.6 | 42.5 ± 22.0 | 42.0 ± 20.8 |
| Gold stage(Participants) | ELVR With Endobronchial Valves | Standard of Care | Total |
|---|---|---|---|
| Gold Stage III | 18 | 23 | 41 |
| Gold Stage IV | 25 | 27 | 52 |
22 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Pulmonx International Sàrl