Status:
TERMINATED
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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) heterogene...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01449292
Start Date
June 1 2012
End Date
November 1 2013
Last Update
November 14 2013
Active Locations (40)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Pulmonary Associates
Phoenix, Arizona, United States, 85006
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
4
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510