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

PHASE3TerminatedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Pulmonary Emphysema
Interventions
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).

Trial Locations (40)

11418

Jamaica Hospital Medical Center, Jamaica

11527

University of Athens - Sotiria General Hospital, Athens

11572

South Nassau Communities Hospital, Oceanside

19140

Temple University Hospital, Philadelphia

21287

The Johns Hopkins Hospital, Baltimore

24014

Carilion Roanoke Memorial Hospital, Roanoke

25123

Azienda Ospedaliera Spedali Civili de Brescia, Brescia

27157

Wake Forest Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

28040

Fundación Jiménez Díaz, Madrid

28374

FirstHealth Moore Regional Hospital, Pinehurst

29203

University of South Carolina School of Medicine, Columbia

30308

Emory University Hospital, Atlanta

31008

Clínica Universidad de Navarra, Pamplona

33136

Miami VA Healthcare System (accepting Miami VA patients only), Miami

35249

The University of Alabama at Birmingham, Birmingham

38043

CHU de Grenoble, Grenoble

44195

Cleveland Clinic, Cleveland

46009

Hospital Universitario y Politécnico La Fe, Valencia

49100

Rabin Medical Center, Petah Tikva

51092

Hôpital Maison Blanche, Reims

55242

University of Iowa Hospitals and Clinics, Iowa City

55905

Mayo Clinic, Rochester

60435

Presence Saint Joseph Medical Center, Joliet

60637

The University of Chicago Medicine, Chicago

61606

Illinois Lung Institute, Peoria

63110

Washington University, St Louis

66606

Veritas Clinical Specialties, Ltd., Topeka

75390

UT Southwestern Medical Center, Dallas

84112

University of Utah, Salt Lake City

85006

Pulmonary Associates, Phoenix

90095

David Geffen School of Medicine at UCLA, Los Angeles

97227

Kaiser Foundation Hospitals (accepting Kaiser patients only), Portland

06510

Yale-New Haven Hospital, New Haven

02115

Brigham and Women's Hospital, Boston

02135

St. Elizabeth's Medical Center, Boston

01805

Lahey Clinic, Burlington

06002

CHU de Nice, Nice

9700 RB

Universitair Medisch Centrum Groningen, Groningen

08907

Hospital Universitari de Bellvitge, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aeris Therapeutics

INDUSTRY

NCT01449292 - Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE) | Biotech Hunter | Biotech Hunter