NL-OMON37128
Completed
Phase 3
Study of the AeriSeal® System for HyPerInflation Reduction in Emphysema (ASPIRE) - ASPIRE Trial
AERIS Therapeutics0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- AERIS Therapeutics
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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