Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

March 12, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Bronchiolitis ObliteransObliterative BronchiolitisBronchiolitis Obliterans Syndrome
Interventions
DRUG

Liposomal Cyclosporine A 5 mg

delivered via the PARI eFlow® device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm

DRUG

Liposomal Cyclosporine A 10 mg

delivered via the PARI eFlow® device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm

Trial Locations (37)

1070

Hôpital Erasme, Brussels

3000

Universitair Ziekenhuis Leuven, Leuven

10032

Columbia University Medical Center, New York

15232

University of Pittsburgh Medical Center, Pittsburgh

19140

Temple University Hospital, Philadelphia

21201

University of Maryland, Baltimore

21287

Johns Hopkins University Hospital, Baltimore

27710

Duke University, Durham

28222

Hospital Universitario Puerta de Hierro - Unidad de Trasplante Pulmonar, Madrid

32610

University of Florida Dept of Pulmonary Medicine, Gainesville

40508

UK Albert B. Chandler Hospital, Lexington

43210

OSU Wexner Medical Center, Columbus

44195

Cleveland Clinic, Cleveland

46026

Unidad de Trasplante Pulmonar del Hospital La Fe, Valencia

46202

Indiana University, Indianapolis

63110

Barnes-Jewish Hospital, St Louis

75246

Baylor University Medical Center, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

Houston Methodist Hospital, Houston

85006

Banner - University Medical Center, Phoenix

90095

David Geffen School of Medicine at UCLA, Los Angeles

92350

Hopital Marie Lannelongue, Le Plessis-Robinson

94143

UCSF, San Francisco

94305

UCSF Center for Advanced Lung Disease, Stanford

Unknown

Waehringer Guertel, Vienna

Copenhagen University Hospital, Copenhagen

CHU Hopital Nord, Marseille

Hopitaux Universitaires de Strasbourg, Strasbourg

Hannover Medical School, Hanover

LMU Klinikum Groshadern, Munich

Rabin Medical Center, Petah Tikva

Complexo Hospitalario de A Coruna, A Coruña

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Marques de Valdecilla, Santander

University of Manchester, Manchester

CB23 3RE

Royal Papworth Hospital NHS Foundation Trust, Cambridge

All Listed Sponsors
lead

Zambon SpA

INDUSTRY

NCT04039347 - Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3) | Biotech Hunter | Biotech Hunter