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

Pulmonary Emphysema Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01449292
• Other study ID #: 03-C11-003PLV
• Status: Terminated
• Phase: Phase 3
• First received: October 6, 2011
• Last updated: November 13, 2013
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Institutional Ethical CommitteeGreece: Ethics CommitteeItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeSpain: Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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:
• 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).

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	CHU de Nice	Nice
France	Hôpital Maison Blanche	Reims
Greece	University of Athens - Sotiria General Hospital	Athens
Israel	Rabin Medical Center	Petach Tikva
Italy	Azienda Ospedaliera Spedali Civili de Brescia	Brescia
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Fundación Jiménez Díaz	Madrid
Spain	Clínica Universidad de Navarra	Pamplona
Spain	Hospital Universitario y Politécnico La Fe	Valencia
United States	Emory University Hospital	Atlanta	Georgia
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of South Carolina School of Medicine	Columbia	South Carolina
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Presence Saint Joseph Medical Center	Joliet	Illinois
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Miami VA Healthcare System (accepting Miami VA patients only)	Miami	Florida
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	South Nassau Communities Hospital	Oceanside	New York
United States	Illinois Lung Institute	Peoria	Illinois
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Kaiser Foundation Hospitals (accepting Kaiser patients only)	Portland	Oregon
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Washington University	St. Louis	Missouri
United States	Veritas Clinical Specialties, Ltd.	Topeka	Kansas
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Countries where clinical trial is conducted

United States,  France,  Greece,  Israel,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 second (FEV1)	Change from baseline measurement of FEV1	12 Months	No
Secondary	Patient Reported Outcomes	Change in Patient reported outcome from baseline.	12 Months	No
Secondary	Exercise Capacity	The change from baseline in Exercise Capacity	12 months	No
Secondary	Radiological Changes	The radiological changes from baseline.	12 months	No