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

  Show 40 Study Locations
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:
emphysema
PLVR
ELVR
AeriSeal System
foam sealant
emphysematous lung sealant
ELS
COPD
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 21, 2014