NCT01449292
Terminated
Phase 3
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Aeris Therapeutics40 sites in 7 countries300 target enrollmentJune 2012
ConditionsPulmonary Emphysema
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pulmonary Emphysema
- Sponsor
- Aeris Therapeutics
- Enrollment
- 300
- Locations
- 40
- Primary Endpoint
- Forced Expiratory Volume in 1 second (FEV1)
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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%
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
Outcomes
Primary Outcomes
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 12 Months
Change from baseline measurement of FEV1
Secondary Outcomes
- Exercise Capacity(12 months)
- Patient Reported Outcomes(12 Months)
- Radiological Changes(12 months)
Study Sites (40)
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