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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025205
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pulmonx Corporation ( Pulmonx International Sàrl )

Brief Summary:
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.

Condition or disease Intervention/treatment Phase
COPD Patients With Homogeneous Emphysema Endoscopic Lung Volume Reduction With Endobronchial Valve Device: Endobronchial Valve Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
Actual Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: ELVR with Endobronchial Valves
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Device: Endobronchial Valve
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

No Intervention: Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.



Primary Outcome Measures :
  1. Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population) [ Time Frame: At baseline and after 3 months ]
    Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.


Secondary Outcome Measures :
  1. Absolute Change in Target Lobe Volume for EBV Group (ITT Population) [ Time Frame: At baseline and after 3 months ]
    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.

  2. Percent Change in Target Lobe Volume for EBV Group (ITT Population) [ Time Frame: At baseline and after 3 months ]
    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.

  3. Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months [ Time Frame: At baseline and after 3 months ]
    The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.

  4. Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months [ Time Frame: At baseline and after 3 months ]
    The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups

  5. Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months [ Time Frame: At baseline and after 3 months ]
    The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups

  6. Absolute Change in Residual Volume (RV) at 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups

  7. Percent Change in Residual Volume (RV) at 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups

  8. Percent Predicted Change in Residual Volume at 3 Months [ Time Frame: At baseline and after 3 months ]
    Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups

  9. Absolute Change in Six-Minute Walk Distance at 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC

  10. Percent Change in Six-Minute Walk Distance at 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC

  11. Absolute Change in the SGRQ Total Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.

  12. Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group

  13. Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.

  14. Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.

  15. Absolute Change in the CAT Total Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.


  16. Percent Change (%) in CAT Total Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.

  17. Absolute Change in EQ-5D Summary Index From Baseline to 3 Months [ Time Frame: At baseline and after 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.


  18. Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months [ Time Frame: At baseline and after 3 months ]
    Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.

  19. Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months [ Time Frame: At baseline and after 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Homogeneous emphysema
  • 15% ≤ FEV1 ≤ 45% predicted
  • TLC > 100% predicted
  • RV ≥ 200% predicted
  • 6MWT ≥ 150 m
  • Non-smoker > 8 weeks prior to study entry
  • Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

  • Active pulmonary infection
  • More than 3 exacerbations with hospitalizations over the past 12 months
  • Pulmonary hypertension (sPAP > 45 mmHg)
  • MI or other relevant CV events in the past 6 months
  • Alpha-1 antitrypsin deficiency
  • Bronchiectasis
  • Prior LVR or LVRS procedure
  • > 20% difference in perfusion between right and left lung
  • Hypercapnia (paCO2 > 55 mmHg
  • Asthma
  • Use of more than 25 mg/day prednisolone or equivalent
  • Severe bullous emphysema
  • Systemic or malignant disease with high death probability within 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025205


Locations
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Austria
Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
Vienna, Austria, 1140
Germany
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, Germany, 45239
Lungenabteilung Thoraxzentrum Hamburg
Hamburg, Germany, 21075
Thoraxklinik am Universitäts klinikum Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Klinikum Nürnberg Nord
Nürnberg, Germany, 90419
Netherlands
Department of pulmonary dieases, University Medical Center
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
Pulmonx International Sàrl
Investigators
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Principal Investigator: 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
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Responsible Party: Pulmonx International Sàrl
ClinicalTrials.gov Identifier: NCT02025205    
Other Study ID Numbers: 630-0014
First Posted: December 31, 2013    Key Record Dates
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases