To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves

N/ACompletedNCT02022683

Pulmonx Corporation97 enrolled

Overview

To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD Heterogeneous Emphysema

Interventions

ELVR (Endoscopic Lung Volume Reduction) with Zephyr ValvesDEVICE

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Obtained informed consent. 2. Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes. 3. Subjects of both genders of at least 40 years of age. 4. 15 % predicted ≤ FEV1≤ 45% predicted. 5. TLC \> 100% and RV ≥ 180% predicted. 6. 150 meters \< 6MWD \< 450 meters. 7. Non-smoker \>8 weeks prior to signing the Informed Consent. 8. CV negative target lobe. Additional inclusion criterion French CIP\*: \- If treated in France, Subject must be entitled to French social security Exclusion Criteria: 1. Any contraindication for bronchoscopic procedure. 2. Evidence of active pulmonary infection. 3. History of 2 or more exacerbations requiring hospitalization over the past 12 months. 4. Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment. 5. Myocardial infarction or other relevant cardiovascular events in the past 6 months. 6. Significant bronchiectasis seen at CT scan. 7. Greater than two tablespoons of sputum production per day. 8. Prior LVR or LVRS procedure. Criterion 8 French CIP wording\*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy). 9. Pulmonary nodule requiring follow-up within any lobe. 10. Pregnant or nursing women. French CIP wording\*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe. 11. Hypercapnia (paCO2 \> 7.33 kPa). 12. Current diagnosis of asthma. 13. \> 25mg Prednisolon (or equivalent) use/days. 14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate. 15. Evidence of pleural adhesions or earlier pulmonary surgery. 16. Severe Bullous Emphysema (\> 1/3 Hemithorax) 17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment. Additional exclusion criteria in the French CIP\*: * History of allergy to silicone and/or nitinol. * If treated in France, Subject is a "personne vulnerable" as defined by French regulation. * Simultaneous participation in another drug and/or medical device related clinical.

Locations (17)

Universiteit Gent

Ghent, Belgium

AZ Delta

Menen, Belgium

Outcomes

Primary Outcomes

Forced Expiratory Volume in 1-second (FEV1) - Responders

The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of \>12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.

Time frame: Between baseline and 3 months

Secondary Outcomes

St George's Respiratory Questionnaire (SGRQ) - Absolute change

Absolute change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: Between Baseline and 3, 6, 12, 18 and 24 months

St George's Respiratory Questionnaire (SGRQ) - Percent change

Percent change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: Between Baseline and 3, 6, 12, 18 and 24 months

Data from ClinicalTrials.gov

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CHU

Grenoble, France

CHU Hôpital Pasteur

Nice, France

Groupe Hospitalier Pitié Salpétrière

Paris, France

Hôpital Bichat Claude Bernard

Paris, France

Charité Campus Virchow-Klinikum

Berlin, Germany

Ruhrlandklinik Westdeutsches Lungenzentrum

Essen, Germany

Thoraxklinik am Universitäts Klinikum Heidelberg

Heidelberg, Germany

University Medical Center Groningen

Groningen, Netherlands

...and 7 more locations

St George's Respiratory Questionnaire (SGRQ) - Responders

Percentage of subject achieving the MCID for SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months, compared to SoC at 3, 6 and 12 months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: Between Baseline and 3, 6, 12, 18 and 24 months

6-minute walk distance (6MWT) - Absolute change

Absolute change in 6MWD in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.