Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.

Phase 1

Conditions: Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0Level: LLTClassification code 10049202Term: Bronchiolitis obliteransSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2019-002987-29-FR

Lead Sponsor: BREATH Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

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 of the protocol through their End of Study Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 who developed a new 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term effectiveness and safety of L-CsA plus SoC in the treatment of BOS in single and double lung transplant recipients;Secondary Objective: Not applicable;Primary end point(s): Mean change in forced expiratory volume in 1 second (FEV1) (mL) from baseline to week 24;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Mean change in FEV1 (mL) from baseline to Week 48<br>• Mean change in FEV1 (mL) from baseline to End of Study<br>• Mean change in FEV1/forced vital capacity (FVC) from baseline to Week 24<br>• Mean change in FEV1/FVC from baseline to Week 48<br>• Time to progression of BOS, defined as the earliest of the following:<br> o Absolute decrease from baseline in FEV1 >/= 10% or >/=200 mL and absolute decrease in FEV1/FVC of > 5%, OR <br> o Change in BOS severity (according to criteria in Verleden 2019), OR<br> o Re-transplantation, OR<br> o Death from respiratory failure<br>;Timepoint(s) of evaluation of this end point: • week 48<br>• end of study<br>• week 24<br>• week 48<br>• Time to progression

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