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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01449292
First received: October 6, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Pulmonary Emphysema
Device: Treatment plus Optimal Medical Therapy
Other: Optimal Medical Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Change from baseline measurement of FEV1


Secondary Outcome Measures:
  • Patient Reported Outcomes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Change in Patient reported outcome from baseline.

  • Exercise Capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The change from baseline in Exercise Capacity

  • Radiological Changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The radiological changes from baseline.


Estimated Enrollment: 300
Study Start Date: June 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449292

  Hide Study Locations
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
France
CHU de Grenoble
Grenoble, France, 38043
CHU de Nice
Nice, France, 06002
Hôpital Maison Blanche
Reims, France, 51092
Greece
University of Athens - Sotiria General Hospital
Athens, Greece, 11527
Israel
Rabin Medical Center
Petach Tikva, Israel, 49100
Italy
Azienda Ospedaliera Spedali Civili de Brescia
Brescia, Italy, 25123
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700 RB
Spain
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
  More Information

No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01449292     History of Changes
Other Study ID Numbers: 03-C11-003PLV
Study First Received: October 6, 2011
Last Updated: November 13, 2013
Health Authority: France: Ministry of Health
France: Institutional Ethical Committee
Greece: Ethics Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Spain: Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Aeris Therapeutics:
PLVR
ELVR
AeriSeal System
foam sealant
emphysematous lung sealant
ELS
COPD
emphysema
polymeric lung volume reduction
heterogeneous
Respiratory Tract Diseases
Lung Diseases
Chronic Obstructive Pulmonary Disease

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

ClinicalTrials.gov processed this record on October 30, 2014