Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
ASPIRE
1 other identifier
interventional
300
7 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2012
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 14, 2013
November 1, 2013
1.4 years
October 6, 2011
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced Expiratory Volume in 1 second (FEV1)
Change from baseline measurement of FEV1
12 Months
Secondary Outcomes (3)
Patient Reported Outcomes
12 Months
Exercise Capacity
12 months
Radiological Changes
12 months
Study Arms (2)
Treatment plus Optimal Medical Therapy
EXPERIMENTALPatients will be treated with the AeriSeal System and Optimal Medical Therapy
Optimal Medical Therapy
ACTIVE COMPARATORPatients will be treated according to Optimal Medical Therapy
Interventions
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).
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).
Eligibility Criteria
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)
- MWT 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:
- +3 more criteria
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
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
The University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Pulmonary Associates
Phoenix, Arizona, 85006, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Miami VA Healthcare System (accepting Miami VA patients only)
Miami, Florida, 33136, United States
Emory University Hospital
Atlanta, Georgia, 30308, United States
The University of Chicago Medicine
Chicago, Illinois, 60637, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, 60435, United States
Illinois Lung Institute
Peoria, Illinois, 61606, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 55242, United States
Veritas Clinical Specialties, Ltd.
Topeka, Kansas, 66606, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
South Nassau Communities Hospital
Oceanside, New York, 11572, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kaiser Foundation Hospitals (accepting Kaiser patients only)
Portland, Oregon, 97227, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
CHU de Grenoble
Grenoble, 38043, France
CHU de Nice
Nice, 06002, France
Hôpital Maison Blanche
Reims, 51092, France
University of Athens - Sotiria General Hospital
Athens, 11527, Greece
Rabin Medical Center
Petah Tikva, 49100, Israel
Azienda Ospedaliera Spedali Civili de Brescia
Brescia, 25123, Italy
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46009, Spain
Related Publications (1)
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.
PMID: 25837041DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 10, 2011
Study Start
June 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11