Lung Diseases Clinical Trial
To evaluate the efficacy of aerosolized cyclosporine given in addition to the standard oral immunosuppressive drug regimen, in preventing acute rejection immediately after lung transplantation
BACKGROUND:
Success with lung transplantation has largely been due to the introduction of cyclosporine
which has proved effective in controlling lung allograft rejection. Nevertheless, acute and
chronic rejection are prevalent in spite of immunosuppressive drug regimens based on oral
cyclosporine. In fact, rejection is more common in recipients of lung allografts than those
who receive other solid organs. Acute rejection is treated with pulsed methylprednisolone
and anti-lymphocyte globulin and consequently recipients are subject to increased risk of
infection and drug toxicity. The hypothesis tested in the study was that delivery of
cyclosporine to the transplanted lung by aerosol inhalation would achieve higher
concentrations of cyclosporine in the graft than when it was delivered via the bloodstream
and that higher concentrations in the graft would prevent rejection more effectively than
systemic immune suppression with the same or reduced toxicity.
Cellular rejection occured in over 90% of the patients within the first year and often
progressed to obliterative bronchiolitis (OB) which was the most common cause of death one
year after transplant. In 1988, the lung transplant group at the University of Pittsburgh
decided to pursue cyclosporine aerosol for the treatment for acute rejection. After animal
testing, initial human experiments were performed, which suggested that cyclosporine aerosol
decreased the prevalence of acute rejection and the development of obliterative
bronchiolitis.
DESIGN NARRATIVE:
This prospective double blind randomized trial was designed to evaluate the efficacy of
cyclosporine aerosol versus placebo aerosol as an adjuvant to oral immunosuppression with
tacrolimus, prednisone, and azathioprine. The hypotheses tested included: 1) acute rejection
would be lower in the patients receiving cyclosporine aerosol, 2) maintenance cyclosporine
aerosol would result in reduced incidence of OB, 3) cytokines and chemokine release would be
suppressed, 4) patients receiving cyclosporine aerosol would require less systemic
immunosuppression and 5) there would be a lower incidence of opportunistic and bacterial
infections as a consequence of more effective immunosuppressive therapy. Another specific
aim of the study was to determine the optimal dose of cyclosporine aerosol that reduced
rejection and/or OB and to correlate radioisotopically labeled inhalation studies with more
easily measurable indices that affected the deposition of aerosolized medications.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record
;
Masking: Double-Blind, Primary Purpose: Prevention
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