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

Phase 3

Terminated

• Conditions: Pulmonary Emphysema
• Interventions: Device: Treatment plus Optimal Medical Therapy; Other: Optimal Medical Therapy

• Registration Number: NCT01449292
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Study Start: 2012-06
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment plus Optimal Medical Therapy	Treatment plus Optimal Medical Therapy	Patients will be treated with the AeriSeal System and Optimal Medical Therapy
Optimal Medical Therapy	Optimal Medical Therapy	Patients will be treated according to Optimal Medical Therapy

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second (FEV1)	12 Months	Change from baseline measurement of FEV1

Secondary Outcome Measures

Name	Time	Method
Exercise Capacity	12 months	The change from baseline in Exercise Capacity
Patient Reported Outcomes	12 Months	Change in Patient reported outcome from baseline.
Radiological Changes	12 months	The radiological changes from baseline.

Trial Locations

Locations (40)

FirstHealth Moore Regional Hospital; 🇺🇸 Pinehurst, North Carolina, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Hôpital Maison Blanche; 🇫🇷 Reims, France

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Veritas Clinical Specialties, Ltd.; 🇺🇸 Topeka, Kansas, United States

Jamaica Hospital Medical Center; 🇺🇸 Jamaica, New York, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Azienda Ospedaliera Spedali Civili de Brescia; 🇮🇹 Brescia, Italy

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

Miami VA Healthcare System (accepting Miami VA patients only); 🇺🇸 Miami, Florida, United States

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Kaiser Foundation Hospitals (accepting Kaiser patients only); 🇺🇸 Portland, Oregon, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Presence Saint Joseph Medical Center; 🇺🇸 Joliet, Illinois, United States

Illinois Lung Institute; 🇺🇸 Peoria, Illinois, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

South Nassau Communities Hospital; 🇺🇸 Oceanside, New York, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

CHU de Grenoble; 🇫🇷 Grenoble, France

University of South Carolina School of Medicine; 🇺🇸 Columbia, South Carolina, United States

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

CHU de Nice; 🇫🇷 Nice, France

University of Athens - Sotiria General Hospital; 🇬🇷 Athens, Greece

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Carilion Roanoke Memorial Hospital; 🇺🇸 Roanoke, Virginia, United States

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain