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



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:11/23/2013
Start Date:June 2012
End Date:August 2019

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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.


Inclusion Criteria:

1. Willing and able to provide informed consent

2. Age ≥ 40 years

3. On optimal medical therapy* for more than 1 month

4. Advanced upper lobe predominant emphysema confirmed by CT scan

5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in
each lung based upon CT scan (total 4 available subsegments)

6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)

7. 6MWT distance ≥ 150 m post pulmonary rehab

8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH:

1. FEV1 < 50% predicted

2. FEV1/FVC ratio < 70%

9. Plethysmographic lung volumes showing BOTH:

1. TLC > 100% predicted

2. RV > 150% predicted

10. DLco ≥ 20% and ≤ 60% predicted

11. Blood gases and oxygen saturation showing BOTH:

1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2

2. PaCO2 < 65 torr

12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks

Exclusion Criteria:

1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung
transplantation

2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)

3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of
Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks

4. Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents,
heparins, oral anticoagulants or investigational medications

Exclusion Criteria (continued):

5. a-1 antitrypsin serum level of < 80 mg/dL (immunodiffusion) or < 11 µmol/L
(nephelometry)

6. CT scan: Presence of any of the following radiologic abnormalities:

1. Pulmonary nodule on CT scan greater than 1.0 cm in diameter

2. Radiologic picture consistent with active pulmonary infection

3. Significant interstitial lung disease

4. Significant pleural disease

5. Giant bullous disease

7. Clinically significant asthma

8. Clinically significant bronchiectasis

9. Pulmonary hypertension

10. Allergy or sensitivity to medications required to safely perform AeriSeal System
treatment under general anesthesia or conscious (moderate procedural) sedation

11. Participation in an investigational study of a drug, biologic, or device not
currently approved for marketing

12. Body mass index < 15 kg/m2 or > 35 kg/m2

13. Female patient pregnant or breast-feeding or planning to be pregnant in the next year

14. Any abnormal screening laboratory test result

15. Significant comorbidity including any of the following:

1. HIV/AIDs

2. Active malignancy

3. Stroke or TIA within 12 months

4. Myocardial infarction within 12 months

5. Congestive heart failure within 12 months

16. 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
We found this trial at
29
sites
Winston-Salem, North Carolina 27157
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Boston, Massachusetts 02135
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Boston, MA
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Chicago, Illinois 60637
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Columbia, South Carolina 29203
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jamaica, New York 11418
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Joliet, Illinois 60435
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Oceanside, New York 11572
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Peoria, Illinois 61606
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Phoenix, Arizona 85006
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Pinehurst, North Carolina 28374
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Portland, OR
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Roanoke, Virginia 24033
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Topeka, Kansas 66606
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