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

Stopped early · Phase 3

Conditions studied: Pulmonary Emphysema

In brief

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.

Key facts

Study ID

NCT01449292

Run by

Aeris Therapeutics

People needed

300

Starts

2012-06-01

Expected to finish

2013-11-01

Last updated by the study team

2013-11-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• Miami VA Healthcare System (accepting Miami VA patients only) — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• Presence Saint Joseph Medical Center — Joliet, Illinois, United States
• Illinois Lung Institute — Peoria, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Veritas Clinical Specialties, Ltd. — Topeka, Kansas, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• South Nassau Communities Hospital — Oceanside, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• FirstHealth Moore Regional Hospital — Pinehurst, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Kaiser Foundation Hospitals (accepting Kaiser patients only) — Portland, Oregon, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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