Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
NCT ID: NCT01449292
Last Updated: 2013-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
300 participants
INTERVENTIONAL
2012-06-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System and Optimal Medical Therapy
Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
Optimal Medical Therapy
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Interventions
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Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Optimal Medical Therapy
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
40 Years
ALL
No
Sponsors
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Aeris Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
University of South Carolina School of Medicine
Columbia, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
CHU de Grenoble
Grenoble, , France
CHU de Nice
Nice, , France
Hôpital Maison Blanche
Reims, , France
University of Athens - Sotiria General Hospital
Athens, , Greece
Rabin Medical Center
Petah Tikva, , Israel
Azienda Ospedaliera Spedali Civili de Brescia
Brescia, , Italy
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Hospital Universitari de Bellvitge
Barcelona, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Countries
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References
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Come CE, Kramer MR, Dransfield MT, Abu-Hijleh M, Berkowitz D, Bezzi M, Bhatt SP, Boyd MB, Cases E, Chen AC, Cooper CB, Flandes J, Gildea T, Gotfried M, Hogarth DK, Kolandaivelu K, Leeds W, Liesching T, Marchetti N, Marquette C, Mularski RA, Pinto-Plata VM, Pritchett MA, Rafeq S, Rubio ER, Slebos DJ, Stratakos G, Sy A, Tsai LW, Wahidi M, Walsh J, Wells JM, Whitten PE, Yusen R, Zulueta JJ, Criner GJ, Washko GR. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015 Sep;46(3):651-62. doi: 10.1183/09031936.00205614. Epub 2015 Apr 2.
Other Identifiers
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03-C11-003PLV
Identifier Type: -
Identifier Source: org_study_id