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Completed

NCT Number: NCT02025205

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

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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Key information

Conditions

COPD Patients With Homogeneous Emphysema Endoscopic Lung Volume Reduction With Endobronchial Valve

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobronchial Valve

Device

Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pulmonx International Sàrl

Industry

Registry information

Official study title

A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema

Acronym: IMPACT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 31, 2013
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.