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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 6, 2020
Sponsor:
Information provided by (Responsible Party):
Breath Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Obliterative Bronchiolitis Bronchiolitis Obliterans Syndrome Drug: Liposomal Cyclosporine A 5 mg Drug: Liposomal Cyclosporine A 10 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Liposomal Cyclosporine A 5 mg
delivered via the PARI eFlow® device

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
Drug: Liposomal Cyclosporine A 10 mg
delivered via the PARI eFlow® device




Primary Outcome Measures :
  1. Mean change in FEV1 from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Mean change in FEV1 from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  2. Mean change in FEV1 from Baseline to End of Study [ Time Frame: Baseline to end of study, approximately 2 years ]
  3. Mean change in FEV1/FVC from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
  4. Mean change in FEV1/FVC from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  5. 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


Other Outcome Measures:
  1. Adverse events [ Time Frame: Baseline through end of study, approximately 2 years ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039347


Locations
Show Show 38 study locations
Sponsors and Collaborators
Breath Therapeutics Inc.
Investigators
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Study Director: Noreen R Henig, MD Breath Therapeutics, Chief Medical Officer
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Responsible Party: Breath Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04039347    
Other Study ID Numbers: BT - L-CsA - 303 - FU
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Syndrome
Disease
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors