Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

Official Title
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Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Device: Treatment plus Optimal Medical Therapy
* Other: Optimal Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent Age ≥ 40 years On optimal medical therapy* for more than 1 month Advanced upper lobe predominant emphysema confirmed by CT scan Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments) MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4) 6MWT distance ≥ 150 m post pulmonary rehab Spirometry 15 minutes after administration of a bronchodilator showing BOTH: FEV1 < 50% predicted FEV1/FVC ratio < 70% Plethysmographic lung volumes showing BOTH: TLC > 100% predicted RV > 150% predicted DLco ≥ 20% and ≤ 60% predicted Blood gases and oxygen saturation showing BOTH: SpO2 ≥ 90% on ≤ 4 L/min supplemental O2 PaCO2 < 65 torr Smoking history of ≥ 20 pack-years with abstinence for 16 weeks Exclusion Criteria: Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation Requirement for ventilator support (other than CPAP or BPAP for sleep apnea) Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications Exclusion Criteria (continued): a-1 antitrypsin serum level of < 80 mg/dL (immunodiffusion) or < 11 µmol/L (nephelometry) CT scan: Presence of any of the following radiologic abnormalities: Pulmonary nodule on CT scan greater than 1.0 cm in diameter Radiologic picture consistent with active pulmonary infection Significant interstitial lung disease Significant pleural disease Giant bullous disease Clinically significant asthma Clinically significant bronchiectasis Pulmonary hypertension Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation Participation in an investigational study of a drug, biologic, or device not currently approved for marketing Body mass index < 15 kg/m2 or > 35 kg/m2 Female patient pregnant or breast-feeding or planning to be pregnant in the next year Any abnormal screening laboratory test result Significant comorbidity including any of the following: HIV/AIDs Active malignancy Stroke or TIA within 12 months Myocardial infarction within 12 months Congestive heart failure within 12 months Any condition that would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment plus Optimal Medical Therapy<br>Patients will be treated with the AeriSeal System and Optimal Medical Therapy | Device: Treatment plus Optimal Medical Therapy<br>* Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).<br>* Other names: AeriSeal System;|
| Active Comparator: Optimal Medical Therapy<br>Patients will be treated according to Optimal Medical Therapy | Other: Optimal Medical Therapy<br>* Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second (FEV1) | Change from baseline measurement of FEV1 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes | Change in Patient reported outcome from baseline. | 12 Months | 
| Exercise Capacity | The change from baseline in Exercise Capacity | 12 months | 
| Radiological Changes | The radiological changes from baseline. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLVR, ELVR, AeriSeal System, foam sealant, emphysematous lung sealant, ELS, COPD, emphysema, polymeric lung volume reduction, heterogeneous, Respiratory Tract Diseases, Lung Diseases, Chronic Obstructive Pulmonary Disease