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Trial record 1 of 2 for:    BOSTON-3
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Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung Transplant (BOSTON-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039347
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2019
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Zambon SpA

Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE March 3, 2020
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
Mean change in FEV1 from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • Mean change in FEV1 from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  • Mean change in FEV1 from Baseline to End of Study [ Time Frame: Baseline to end of study, approximately 2 years ]
  • Mean change in FEV1/FVC from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
  • Mean change in FEV1/FVC from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  • Time to Progression of BOS [ Time Frame: Baseline to End of Study, approximately 2 years ]
    Defined as the earliest of:
    • Absolute decrease from baseline in FEV1 >/= 10% or >/= 200 mL and absolute decrease in FEV1/FVC of > 5%, OR
    • Change in BOS severity (according to criteria in Verleden 2019), OR
    • Re-transplantation, OR
    • Death from respiratory failure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 29, 2019)
  • Adverse events [ Time Frame: Baseline through end of study, approximately 2 years ]
  • Acute tolerability of L-CsA as measured by change in FEV1 at 1 hour and 4 hours after first inhalation of L-CsA [ Time Frame: First treatment with L-CsA ]
  • Acute tolerability of L-CsA as measured by number of patients with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Baseline through end of treatment, approximately 2 years ]
  • Number of patients with treatment-related changes in hematology or serum chemistry parameters assessed by CTCAE v5.0 [ Time Frame: Baseline through end of study participation, approximately 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung Transplant
Official Title  ICMJE A Phase III, Multicenter Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosprine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single or Double Lung Transplantation
Brief Summary 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 Standard of Care, regardless of randomization arm in prior trials.
Detailed Description A maximum of 16 visits will be performed during the clinical trial. During the treatment period, visits are scheduled every 4 - 12 weeks. Study procedures include spirometry (breathing tests), clinical laboratory tests, a Quality of Life assessment, vital signs, physical examinations, and assessment of adverse events.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchiolitis Obliterans
  • Obliterative Bronchiolitis
  • Bronchiolitis Obliterans Syndrome
Intervention  ICMJE
  • Drug: Liposomal Cyclosporine A 5 mg
    delivered via the PARI eFlow® device
  • Drug: Liposomal Cyclosporine A 10 mg
    delivered via the PARI eFlow® device
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: Liposomal Cyclosporine A 5 mg
  • Experimental: 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
    Intervention: Drug: Liposomal Cyclosporine A 10 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients who have completed all visits through the End of Treatment Visit in either BOSTON-1 or BOSTON-2, did not withdraw informed consent, and did not prematurely terminate study drug administration.
  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:

  1. Known hypersensitivity to L-CsA or to cyclosporine A.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Israel,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039347
Other Study ID Numbers  ICMJE BT - L-CsA - 303 - FU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zambon SpA
Study Sponsor  ICMJE Zambon SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paola R Castellani, MD Zambon SpA, Chief Medical Officer
PRS Account Zambon SpA
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP