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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02025205
Other study ID # 630-0014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date March 15, 2017

Study information

Verified date July 2019
Source Pulmonx, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date March 15, 2017
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Endobronchial Valve
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Locations

Country Name City State
Austria Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie Vienna
Germany Charité Campus Virchow-Klinikum Berlin
Germany Ruhrlandklinik, Westdeutsches Lungenzentrum Essen
Germany Lungenabteilung Thoraxzentrum Hamburg Hamburg
Germany Thoraxklinik am Universitäts klinikum Heidelberg Heidelberg
Germany Lungenklinik Hemer Hemer
Germany Klinikum Nürnberg Nord Nürnberg
Netherlands Department of pulmonary dieases, University Medical Center Groningen

Sponsors (1)

Lead Sponsor Collaborator
Pulmonx International Sàrl

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population) Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group. At baseline and after 3 months
Secondary Absolute Change in Target Lobe Volume for EBV Group (ITT Population) Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume. At baseline and after 3 months
Secondary Percent Change in Target Lobe Volume for EBV Group (ITT Population) Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume. At baseline and after 3 months
Secondary Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of = 350ml at 3 Months The threshold of TLVR =350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group. At baseline and after 3 months
Secondary Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups At baseline and after 3 months
Secondary Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups At baseline and after 3 months
Secondary Absolute Change in Residual Volume (RV) at 3 Months Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups At baseline and after 3 months
Secondary Percent Change in Residual Volume (RV) at 3 Months Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups At baseline and after 3 months
Secondary Percent Predicted Change in Residual Volume at 3 Months Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups At baseline and after 3 months
Secondary Absolute Change in Six-Minute Walk Distance at 3 Months Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC At baseline and after 3 months
Secondary Percent Change in Six-Minute Walk Distance at 3 Months Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC At baseline and after 3 months
Secondary Absolute Change in the SGRQ Total Score From Baseline to 3 Months Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations. At baseline and after 3 months
Secondary Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group At baseline and after 3 months
Secondary Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. At baseline and after 3 months
Secondary Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. At baseline and after 3 months
Secondary Absolute Change in the CAT Total Score From Baseline to 3 Months Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group.
The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease.
At baseline and after 3 months
Secondary Percent Change (%) in CAT Total Score From Baseline to 3 Months The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life. At baseline and after 3 months
Secondary Absolute Change in EQ-5D Summary Index From Baseline to 3 Months Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state.
At baseline and after 3 months
Secondary Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group. At baseline and after 3 months
Secondary Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome. At baseline and after 3 months