Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
NCT ID: NCT04039347
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
262 participants
INTERVENTIONAL
2020-03-12
2025-12-31
Brief Summary
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Detailed Description
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Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to SoC, regardless of the randomization arm in prior trials.
IMP will be administered by BID inhalation (morning/evening) using the L-CsA eFlow. Patients who did not receive L-CsA in BOSTON-1 or BOSTON-2 must remain in the clinic for at least 4 hours for observation after the first inhalation. At all subsequent visits, one dose administered via inhalation will be monitored by the clinical trial center personnel. In case patients receiving L-CsA undergo the last visit for BOSTON-1 or BOSTON-2 (Visit 9) on the same day as for Visit 1 for BOSTON-3, they will take the first dose for Boston 3 in the evening of this day. This first dose will not be supervised by the site staff. Nebulization time per inhalation dose is approximately 6-10 minutes for the 5 mg dose and 9-13 minutes for the 10 mg dose. Inhalations will be performed BID approximately 12 hours apart through a mouthpiece by slow and deep respiration using the L-CsA eFlow. A high efficiency particulate air filter is used to prevent environmental contamination during exhalation.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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L-CsA 5 mg plus Standard of Care
L-CsA 5 mg twice daily plus Standard of Care for up to 144 weeks for patients post Single Lung Transplant
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
L-CsA 10 mg plus Standard of Care
L-CsA 10 mg twice daily plus Standard of Care for up to 144 weeks for patients post Double Lung Transplant
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients should be on a three-drug maintenance regimen of immunosuppressive agents including tacrolimus or another CNI, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone.
3. Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation.
4. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Visit 1 and must agree to use one of the methods of contraception listed in Appendix II through their End of Study Visit.
Exclusion Criteria
2. Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2.
3. Patients with new onset of malignancy while participating in BOSTON-1 or BOSTON-2, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
4. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.
5. Women who are currently breastfeeding.
6. Receipt of an investigational drug, other than L-CsA, as part of a clinical trial within 4 weeks prior to Visit 1. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
7. Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-2.
8. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
9. Any co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the patient's participation in the clinical trial.
18 Years
ALL
No
Sponsors
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Zambon SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Paola R Castellani, MD
Role: STUDY_DIRECTOR
Zambon SpA, Chief Medical Officer
Locations
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Banner - University Medical Center
Phoenix, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UCSF
San Francisco, California, United States
UCSF Center for Advanced Lung Disease
Stanford, California, United States
University of Florida Dept of Pulmonary Medicine
Gainesville, Florida, United States
Indiana University
Indianapolis, Indiana, United States
UK Albert B. Chandler Hospital
Lexington, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Waehringer Guertel
Vienna, , Austria
Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Copenhagen University Hospital
Copenhagen, , Denmark
Hopital Marie Lannelongue
Le Plessis-Robinson, , France
CHU Hopital Nord
Marseille, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Hannover Medical School
Hanover, , Germany
LMU Klinikum Groshadern
Munich, , Germany
Rabin Medical Center
Petah Tikva, , Israel
Complexo Hospitalario de A Coruna
A Coruña, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Unidad de Trasplante Pulmonar
Madrid, , Spain
Hospital Marques de Valdecilla
Santander, , Spain
Unidad de Trasplante Pulmonar del Hospital La Fe
Valencia, , Spain
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
University of Manchester
Manchester, , United Kingdom
Countries
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Other Identifiers
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2019-002987-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BT - L-CsA - 303 - FU
Identifier Type: -
Identifier Source: org_study_id
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