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

Phase 3

Completed

Conditions: COPD
Emphysema
10038716

Registration Number: NL-OMON37128

Lead Sponsor: AERIS Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

age >40
advanced upper lobe emphysema on CT
mMRC 2 or higher
6-MWD > 150 m post pulmonary rehab
post BD FEV < 50 % pred.
TLC > 100 % pred.
RV > 150 % pred.
DLco >= 20% and <= 60% pred.
non-smoking 16 weeks prior to study

Exclusion Criteria

Body mass index < 15 kg/m2 or > 35 kg/m2
Alpha1-antitrypsin serum level of <80 mg/dL (i.e. < 11 µmol/L) at screening
Female patient pregnant or breast-feeding
Clinically significant asthma, chronic bronchitis, bronchiectasis or, pulmonary hypertension
Three or more COPD exacerbations requiring hospitalization within 1 year of screening or a COPD exacerbation requiring hospitalization within 8 weeks of Screening
Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
Significant comorbidity that carries prohibitive risks
CT scan: Presence of the following radiologic abnormalities: Unstable pulmonary nodule on CT scan greater than 1.0 cm in diameter, infiltrate, interstitial lung disease, significant pleural disease, giant bullous disease (> 10 cm)
Requirement for mechanical ventilator support (invasive or non-invasive)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Endpoint: FEV1 at 12 months post treatment </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Efficacy Endpoints:<br /><br>1. FEV1: The proportion of patients achieving at least a 12% and 100 mL<br /><br>increase in postbronchodilator FEV1 at 12 months post treatment<br /><br>2. Upper Lobe Volume by CT Scan: The mean change from baseline in upper lobe<br /><br>volume measured by quantitative CT scan at 12 months post treatment<br /><br>3. St. George*s Respiratory Questionnaire (SGRQ): The proportion of patients<br /><br>achieving at least a 4U decrease in SGRQ total domain score at 12 months post<br /><br>treatment<br /><br>4. Medical Research Council Dyspnea (MRCD): The proportion of patients<br /><br>achieving at least a 1U decrease in MRCD score at 12 months post treatment<br /><br>5. Six Minute Walk Test (6MWT): The mean change from baseline in 6MWT at 12<br /><br>months post treatment</p><br>