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

November 13, 2013 updated by: Aeris Therapeutics
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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 Names:
  • AeriSeal System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 12 Months
Change from baseline measurement of FEV1
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes
Time Frame: 12 Months
Change in Patient reported outcome from baseline.
12 Months
Exercise Capacity
Time Frame: 12 months
The change from baseline in Exercise Capacity
12 months
Radiological Changes
Time Frame: 12 months
The radiological changes from baseline.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aeris Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-C11-003PLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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