drugset / Trial / NCT01432080

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

NCT01432080

RandomizedParallel-groupOpen-labelPrevention

Summary

For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. Currently, patients with transplant-related lung disease are treated with some combination of steroids and other immunosuppressant drugs, but only about 1 out of 5 improve. The importance of our study is that the investigators aim to prevent the development of transplant-related chronic lung disease in the first place. Because a strong risk factor for such chronic lung disease is a prior viral respiratory tract infection, the investigators think there is a window of opportunity to intervene. As soon as "cold and flu" symptoms start, the investigators will treat patients with a combination of drugs aimed at eliminating damaging immune responses triggered by the virus. In the absence of such treatment, the investigators believe these lung-damaging immune responses would persist even after the virus disappears. Our hope is that preventive treatment might avoid the development of chronic lung disease, and this would substantially increase long-term survival in our transplant patients. This is a pilot study. Once feasibility is established, the investigators will seek to expand this study into a definitive clinical trial.

Timeline

Start
2011-09
Primary completion
2012-12
Completion
2013-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg Oral
Subject Montelukast Other / unclassified 10 mg Oral
Subject Prednisone Other / unclassified 0.75 mg/kg Oral
Subject Symbicort Unknown 6 ug Inhaled
Subject Symbicort Unknown 200 ug Inhaled