A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant

2019-10-03 07:54:46 | BioPortfolio


This is a Phase II prospective, multi-center, single-blind, randomized clinical trial of safety in the treatment of BOS 1 in adult recipients of an allogeneic hematopoetic stem cell transplant. Twenty-four patients are planned for enrollment. The clinical trial will be conducted in approximately 20 centers in Germany, France, and Spain. Patients will be randomly allocated 1:1:1 to receive either L-CsA (10 mg bid or 5 mg bid) plus Standard of Care, or liposomal placebo plus Standard of Care. Investigational Medicinal Product will be administered for up to 12 weeks.


Development of BOS after hematopoetic stem cell transplant (HSCT) is a major cause of morbidity and mortality; treatment options are limited and have not been optimized by well-conducted clinical trials. The hypothesis that local delivery of CsA by aerosol inhalation will achieve higher intrapulmonary concentration than by systemic administration alone, with limited toxicity compared to similar systemic doses due to minimal absorption of drug into the blood circulation has been substantiated by previous studies. The objectives of this study are to assess the tolerability, safety, PK, and exploratory efficacy of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for the treatment of BOS in adult allogeneic HSCT recipients.

Study Design


Bronchiolitis Obliterans


Liposomal Cyclosporine A, Liposomal Placebo


Not yet recruiting


Breath Therapeutics Inc.

Results (where available)

View Results


Published on BioPortfolio: 2019-10-03T07:54:46-0400

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