Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-25 @ 2:38 AM
Study NCT ID:
NCT02025205
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2013-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nshargill@pulmonx.com', 'phone': '650-216-0108', 'title': 'Narinder Shargill, Vice President, Global Medical and Clinical Affairs', 'organization': 'Pulmonx'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve', 'otherNumAtRisk': 43, 'otherNumAffected': 30, 'seriousNumAtRisk': 43, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.', 'otherNumAtRisk': 50, 'otherNumAffected': 22, 'seriousNumAtRisk': 50, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COPD Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucus production', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary granulations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary shunt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COPD Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diagnostic bronchoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Target Lobe Volume for EBV Group (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}], 'classes': [{'categories': [{'measurements': [{'value': '1195', 'spread': '683.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', '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.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Target Lobe Volume for EBV Group (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}], 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '32.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', '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.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline and after 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups', 'unitOfMeasure': 'Percent predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Residual Volume (RV) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Residual Volume (RV) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '19.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Predicted Change in Residual Volume at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.1', 'spread': '47.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '53.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Six-Minute Walk Distance at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '66.6', 'groupId': 'OG000'}, {'value': '-17.3', 'spread': '52.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Six-Minute Walk Distance at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in the SGRQ Total Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.", 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.8', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '59.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in the CAT Total Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.\n\nThe 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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change (%) in CAT Total Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in EQ-5D Summary Index From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.\n\nEQ-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.\n\nThe 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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '70.1', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '115.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BLVR With Zephyr Endobronchial Valves', 'description': 'Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves\n\nEndobronchial Valve: Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Endobronchial Valve'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ELVR With Endobronchial Valves', 'description': 'Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve\n\nEndobronchial Valve: Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '168.7', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '165.4', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '166.9', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.9', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '12', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '22.6', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pack Years Smoking History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.5', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '22.0', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '20.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pack-years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.'}, {'title': 'Gold stage', 'classes': [{'title': 'Gold Stage III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Gold Stage IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants'}, {'title': 'Emphysema score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.0', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heterogeneity index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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:\n\n1. Homogeneous emphysema = heterogeneity index between target and adjacent lobes of \\<15%.\n2. Heterogeneous emphysema = heterogeneity index between target and adjacent lobes of ≥15%.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.4', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Residual Volume (RV) (Liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Residual Volume (RV) (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '277.3', 'spread': '55.2', 'groupId': 'BG000'}, {'value': '273.7', 'spread': '63.4', 'groupId': 'BG001'}, {'value': '275.4', 'spread': '59.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Lung Capacity (TLC) (Liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Lung Capacity (TLC) (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '144.9', 'spread': '21.2', 'groupId': 'BG000'}, {'value': '144.2', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '144.6', 'spread': '19.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1/FVC (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.3', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RV/TLC (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.0', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '6 Minute Walk Distance (meters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '308.0', 'spread': '91.3', 'groupId': 'BG000'}, {'value': '328.3', 'spread': '92.6', 'groupId': 'BG001'}, {'value': '318.9', 'spread': '92.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SGRQ Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.2', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '14.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "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:\n\nPart I: Symptoms (frequency \\& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)\n\nA 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.", 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.'}, {'title': 'The COPD Assessment Test (CAT) total score (derived)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.4', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.", 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number of subjects in the SoC group analyzed for CAT Total Score, derived is less than the overall population, due to missing data.'}, {'title': 'EQ-5D Summary Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.'}, {'title': 'EQ-5D health state today', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '19.3', 'groupId': 'BG001'}, {'value': '45.2', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "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.\n\nScores range from 0 to 100, with lower scores indicating worse health states.", 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.'}, {'title': 'mMRC Dyspnea Grade score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number of subjects in the EBV group analyzed for mMRC breathlessness grade is less than the overall population, due to missing data.'}, {'title': 'BODE index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '5.4', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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:\n\n0 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', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number of subjects in the EBV group analyzed for BODE index is less than the overall population, due to missing data.'}, {'title': 'EQ-5D Mobility', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Some problems', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Confined to bed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'EQ-5D Self-Care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Some problems', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unable', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'EQ-5D usual activities', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Some problems', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Unable', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'EQ-5D Pain/Discomfort', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Extreme', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'EQ-5D Anxiety/Depression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Extreme', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2013-12-21', 'resultsFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2013-12-27', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-09', 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)', 'timeFrame': 'At baseline and after 3 months', 'description': 'Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Target Lobe Volume for EBV Group (ITT Population)', 'timeFrame': 'At baseline and after 3 months', '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.'}, {'measure': 'Percent Change in Target Lobe Volume for EBV Group (ITT Population)', 'timeFrame': 'At baseline and after 3 months', '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.'}, {'measure': 'Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months', 'timeFrame': 'At baseline and after 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.'}, {'measure': 'Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups'}, {'measure': 'Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups'}, {'measure': 'Absolute Change in Residual Volume (RV) at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups'}, {'measure': 'Percent Change in Residual Volume (RV) at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups'}, {'measure': 'Percent Predicted Change in Residual Volume at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups'}, {'measure': 'Absolute Change in Six-Minute Walk Distance at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC'}, {'measure': 'Percent Change in Six-Minute Walk Distance at 3 Months', 'timeFrame': 'At baseline and after 3 months', 'description': 'Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC'}, {'measure': 'Absolute Change in the SGRQ Total Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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."}, {'measure': 'Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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'}, {'measure': 'Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.'}, {'measure': 'Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.'}, {'measure': 'Absolute Change in the CAT Total Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.\n\nThe 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.'}, {'measure': 'Percent Change (%) in CAT Total Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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."}, {'measure': 'Absolute Change in EQ-5D Summary Index From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.\n\nEQ-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.\n\nThe 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.'}, {'measure': 'Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.'}, {'measure': 'Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months', 'timeFrame': 'At baseline and after 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['COPD Patients With Homogeneous Emphysema', 'Endoscopic Lung Volume Reduction With Endobronchial Valve']}, 'referencesModule': {'references': [{'pmid': '39515624', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homogeneous emphysema\n* 15% ≤ FEV1 ≤ 45% predicted\n* TLC \\> 100% predicted\n* RV ≥ 200% predicted\n* 6MWT ≥ 150 m\n* Non-smoker \\> 8 weeks prior to study entry\n* Absence of Collateral Ventilation in the target lobe\n\nExclusion Criteria:\n\n* Active pulmonary infection\n* More than 3 exacerbations with hospitalizations over the past 12 months\n* Pulmonary hypertension (sPAP \\> 45 mmHg)\n* MI or other relevant CV events in the past 6 months\n* Alpha-1 antitrypsin deficiency\n* Bronchiectasis\n* Prior LVR or LVRS procedure\n* \\> 20% difference in perfusion between right and left lung\n* Hypercapnia (paCO2 \\> 55 mmHg\n* Asthma\n* Use of more than 25 mg/day prednisolone or equivalent\n* Severe bullous emphysema\n* Systemic or malignant disease with high death probability within 12 months'}, 'identificationModule': {'nctId': 'NCT02025205', 'acronym': 'IMPACT', 'briefTitle': 'Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmonx Corporation'}, 'officialTitle': 'A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema', 'orgStudyIdInfo': {'id': '630-0014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELVR with Endobronchial Valves', 'description': 'Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve', 'interventionNames': ['Device: Endobronchial Valve']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients will receive optimal drug therapy and medical management according to clinical practice.'}], 'interventions': [{'name': 'Endobronchial Valve', 'type': 'DEVICE', 'description': 'Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve', 'armGroupLabels': ['ELVR with Endobronchial Valves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik, Westdeutsches Lungenzentrum', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '21075', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Lungenabteilung Thoraxzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik am Universitäts klinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '58675', 'city': 'Hemer', 'country': 'Germany', 'facility': 'Lungenklinik Hemer', 'geoPoint': {'lat': 51.38707, 'lon': 7.77019}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Nord', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Department of pulmonary dieases, University Medical Center', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Arschang Valipour, MD, PhD, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria'}, {'name': 'Felix Herth (co-principal investigator), MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}, {'name': 'Ralf Eberhardt (co-principal investigator), MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonx International Sàrl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}