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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELVR with Endobronchial Valves | Experimental | Endoscopic 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial Valve | Device | Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and after 3 months |
| Percent Change in Target Lobe Volume for EBV Group (ITT Population) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arschang Valipour, MD, PhD, FCCP | Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria | Principal Investigator |
| Felix Herth (co-principal investigator), MD | Heidelberg University | Principal Investigator |
| Ralf Eberhardt (co-principal investigator), MD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie | Vienna | 1140 | Austria | |||
| Charité Campus Virchow-Klinikum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39515624 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLVR With Zephyr Endobronchial Valves | Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At baseline and after 3 months |
| Berlin |
| 13353 |
| Germany |
| Ruhrlandklinik, Westdeutsches Lungenzentrum | Essen | 45239 | Germany |
| Lungenabteilung Thoraxzentrum Hamburg | Hamburg | 21075 | Germany |
| Thoraxklinik am Universitäts klinikum Heidelberg | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Klinikum Nürnberg Nord | Nuremberg | 90419 | Germany |
| Department of pulmonary dieases, University Medical Center | Groningen | 9700RB | Netherlands |
Patients will receive optimal drug therapy and medical management according to clinical practice.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ELVR With Endobronchial Valves | Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve Endobronchial Valve: Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve |
| BG001 | Standard of Care | Patients will receive optimal drug therapy and medical management according to clinical practice. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Pack Years Smoking History | The number of subjects in the EBV and SoC group analyzed for Pack year smoking history is less than the overall population, due to missing data. | Median | Standard Deviation | pack-years |
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| Gold stage | The GOLD system uses the term "stages" to refer to the different levels of COPD. Participants graded as GOLD Stage III are considered to have Severe COPD. Participants graded as GOLD Stage IV are considered to have Very Severe COPD. | Count of Participants | Participants |
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| Emphysema score | Emphysema score was assessed as the percentage of voxels of less than -910 Hounsfield units on Computerized Tomography (CT). Scores range from 0 to 100%, with higher scores indicating more emphysematous destruction. | Mean | Standard Deviation | percent |
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| Heterogeneity index | Difference in emphysema destruction scores between potential target and ipsilateral lung lobes, calculated from the high-resolution computer tomography scan (HRCT) read. The classification of Homogeneous or Heterogeneous emphysema follows the below criteria:
| Mean | Standard Deviation | units on a scale |
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| FEV1 (liters) | Mean | Standard Deviation | Liters |
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| FEV1 (% predicted) | Mean | Standard Deviation | % predicted |
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| Residual Volume (RV) (Liters) | Mean | Standard Deviation | Liters |
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| Residual Volume (RV) (% predicted) | Mean | Standard Deviation | % predicted |
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| Total Lung Capacity (TLC) (Liters) | Mean | Standard Deviation | Liter |
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| Total Lung Capacity (TLC) (% predicted) | Mean | Standard Deviation | % predicted |
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| FEV1/FVC (%) | Mean | Standard Deviation | percent |
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| RV/TLC (%) | Mean | Standard Deviation | percent |
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| 6 Minute Walk Distance (meters) | Mean | Standard Deviation | meters |
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| SGRQ Total Score | The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. | The number of subjects in the EBV and SoC group analyzed for SGRQ Total Score is less than the overall population, due to missing data. | Mean | Standard Deviation | points on a scale |
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| The COPD Assessment Test (CAT) total score (derived) | 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. | The number of subjects in the SoC group analyzed for CAT Total Score, derived is less than the overall population, due to missing data. | Mean | Standard Deviation | points on a scale |
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| EQ-5D Summary Index | 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. | The number of subjects in the EBV and SoC group analyzed for EQ-5D summary index, Europe is less than the overall population, due to missing data. | Mean | Standard Deviation | points on a scale |
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| EQ-5D health state today | EQ-5D is a standardized instrument to measure health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS (visual analogue scale). The EQ VAS corresponds to the EQ-5D health state today and records the respondent's self-rated health on a vertical scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. Scores range from 0 to 100, with lower scores indicating worse health states. | The number of subjects in the EBV and SoC group analyzed for EQ-5D Health State today is less than the overall population, due to missing data. | Mean | Standard Deviation | score |
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| mMRC Dyspnea Grade score | 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. | The number of subjects in the EBV group analyzed for mMRC breathlessness grade is less than the overall population, due to missing data. | Mean | Standard Deviation | points on a scale |
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| BODE index | The BODE Index is comprised of a person's body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E"). Each of these components is graded on a scale of either 0 to 1 or 0 to 3. The final value-ranging from 0 to 10-provides doctors a percentage of how likely a person is to survive for four years. The final BODE tabulation is described as follows: 0 to 2 points: 80 percent likelihood of survival 3 to 4 points: 67 percent likelihood of survival 5 of 6 points: 57 percent likelihood of survival 7 to 10 points: 18 percent likelihood of survival | The number of subjects in the EBV group analyzed for BODE index is less than the overall population, due to missing data. | Mean | Standard Deviation | points on a scale |
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| EQ-5D Mobility | The number of subjects in the EBV and SOC group analyzed for EQ-5D mobility is less than the overall population, due to missing data. | Count of Participants | Participants |
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| EQ-5D Self-Care | The number of subjects in the EBV and SoC group analyzed for EQ-5D Self-Care is less than the overall population, due to missing data. | Count of Participants | Participants |
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| EQ-5D usual activities | The number of subjects in the EBV and SoC group analyzed for EQ-5D Usual Activities is less than the overall population, due to missing data. | Count of Participants | Participants |
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| EQ-5D Pain/Discomfort | The number of subjects in the EBV and SoC group analyzed for EQ-5D pain/discomfort is less than the overall population, due to missing data. | Count of Participants | Participants |
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| EQ-5D Anxiety/Depression | The number of subjects in the EBV and SoC group analyzed for EQ-5D anxiety/depression is less than the overall population, due to missing data. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population | Posted | Mean | Standard Deviation | percent change | At baseline and after 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mL | At baseline and after 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Count of Participants | Participants | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | liters | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | Percent predicted | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | liters | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | Percent change | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | Percent change | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | meters | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | Percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | points on a scale | At baseline and after 3 months |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | points on a scale | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | Percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | points on a scale | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | points on a scale | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | percent change | At baseline and after 3 months |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | points on a scale | At baseline and after 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BLVR With Zephyr Endobronchial Valves | Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves Endobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve | 28 | 43 | 30 | 43 | ||
| EG001 | Standard of Care | Patients will receive optimal drug therapy and medical management according to clinical practice. | 16 | 50 | 22 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Diagnostic bronchoscopy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Mucus production | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary granulations | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary infection | Infections and infestations | Non-systematic Assessment |
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| Pulmonary shunt | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Thoracic pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Pulmonary lesion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Narinder Shargill, Vice President, Global Medical and Clinical Affairs | Pulmonx | 650-216-0108 | nshargill@pulmonx.com |
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