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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449292
Recruitment Status : Terminated
First Posted : October 10, 2011
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Aeris Therapeutics

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.

Condition or disease Intervention/treatment Phase
Pulmonary Emphysema Device: Treatment plus Optimal Medical Therapy Other: Optimal Medical Therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Study Start Date : June 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System and Optimal Medical Therapy
Device: 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).
Other Name: AeriSeal System
Active Comparator: Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
Other: 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).

Primary Outcome Measures :
  1. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ]
    Change from baseline measurement of FEV1

Secondary Outcome Measures :
  1. Patient Reported Outcomes [ Time Frame: 12 Months ]
    Change in Patient reported outcome from baseline.

  2. Exercise Capacity [ Time Frame: 12 months ]
    The change from baseline in Exercise Capacity

  3. Radiological Changes [ Time Frame: 12 months ]
    The radiological changes from baseline.

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01449292

  Hide Study Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Florida
Miami VA Healthcare System (accepting Miami VA patients only)
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30308
United States, Illinois
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Presence Saint Joseph Medical Center
Joliet, Illinois, United States, 60435
Illinois Lung Institute
Peoria, Illinois, United States, 61606
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 55242
United States, Kansas
Veritas Clinical Specialties, Ltd.
Topeka, Kansas, United States, 66606
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
South Nassau Communities Hospital
Oceanside, New York, United States, 11572
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Kaiser Foundation Hospitals (accepting Kaiser patients only)
Portland, Oregon, United States, 97227
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 29203
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
CHU de Grenoble
Grenoble, France, 38043
CHU de Nice
Nice, France, 06002
Hôpital Maison Blanche
Reims, France, 51092
University of Athens - Sotiria General Hospital
Athens, Greece, 11527
Rabin Medical Center
Petach Tikva, Israel, 49100
Azienda Ospedaliera Spedali Civili de Brescia
Brescia, Italy, 25123
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700 RB
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Fundación Jiménez Díaz
Madrid, Spain, 28040
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Aeris Therapeutics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Aeris Therapeutics Identifier: NCT01449292     History of Changes
Other Study ID Numbers: 03-C11-003PLV
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Aeris Therapeutics:
AeriSeal System
foam sealant
emphysematous lung sealant
polymeric lung volume reduction
Respiratory Tract Diseases
Lung Diseases
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases