A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Study Overview
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Brief Summary
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The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes. The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose. The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.

Official Title
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A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Conditions
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Emphysema, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: IAB System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Diagnosis of COPD/emphysema Age 40 to 75 years Body Mass Index (BMI) less than 30 kg/m2 6-minute walk Distance between 100 meters and 500 meters at baseline exam Stable disease with less than 10 mg prednisone (or equivalent) daily Non-smoking for 4 months prior to screening interview FEV1 between 15% and 50% of predicted value at baseline exam FEV1/Forced Vital Capacity (FVC) < 70% RV > 175% mMRC score ≥ 2 Exclusion Criteria: Currently participating in another clinical study Women of child-bearing potential More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening Any COPD exacerbations within 6 weeks of planned intervention Two or more instances of pneumonia episodes in the last year at screening Clinically significant mucus production or chronic bronchitis Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy Clinically significant bronchiectasis Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit) Suspected pulmonary nodule or lung cancer High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows: Large bullae encompassing greater than 30% of either lung Insufficient landmarks to evaluate the CT study using the software as it is intended All lobes are less than 25% parenchyma diseased (< -950 HU) Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant Total Lung Capacity (TLC) < 100% predicted at screening Diffusing Capacity of Carbon Monoxide (DLCO) < 15% or > 50% of predicted value at screening Partial pressure of carbon dioxide (PaCO2) > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening Partial pressure of oxygen (PaO2) < 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) > 2.5% at screening Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema. There is no control group or comparator.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IAB System<br>Patients will be treated with IAB(s) | Device: IAB System<br>* Bronchoscopic implantation of one or multiple IABs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Incidence of respiratory serious adverse events (SAEs) | The primary endpoint is the occurrence of respiratory SAEs: Acute asthma/bronchospasm requiring intensive/critical care unit admission Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization) Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention Death from procedure/IAB Massive hemoptysis (est. >100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. & IV antibiotics) Pneumothorax requiring surgery Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. & treatment) Respiratory failure requiring mechanical ventilatory support >24hr A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated. | From baseline to 90 days post implant (for endpoint evaluation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Incidence of other serious adverse device effects (SADEs) | All other SADEs are a secondary endpoint, made from the accumulation of adverse events (AEs) to be recorded as they occur regardless of the follow-up schedule. | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Residual Volume (RV), absolute change | Absolute change in Residual Volume (RV) | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Residual Volume (RV), percent change | Percent change in RV (% predicted) | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change | Absolute change in FEV1 | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change | Percentage change in FEV1 | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Six-Minute Walk Distance (6MWD), absolute change | Absolute change in 6MWD | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Six-Minute Walk Distance (6MWD), percent change | Percent change in 6MWD | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change | Absolute change in mMRC dyspnea score. Scores range from 0-4, with a decrease in score representing improved perception of disability attributable to dyspnea. | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change | Absolute change in SGRQ total score. Scores range from 0-100, with a decrease in score representing overall improvement in health, daily life, and perceived well-being. | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change | Percent change in SGRQ | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - COPD Assessment Test (CAT), absolute change | Absolute changes in CAT. Scores range from 0-40, with a decrease in score representing decreased impact of cough, sputum, dyspnea, and chest tightness on overall health status. | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - COPD Assessment Test (CAT) Total Score, percent change | Percent change in CAT Total Score | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change | Absolute change in EQ-5D Summary Index. Index values range from 0-1, with a decrease in index value indicating an improvement in health-related quality of life. | From baseline to 90 days post implant (for endpoint evaluation) | 
| Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change | Percent change in EQ-5D Summary Index | From baseline to 90 days post implant (for endpoint evaluation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopic Lung Volume Reduction (BLVR)