NCT01432080

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

Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Tract Infections
• Bronchiolitis Obliterans
• Cryptogenic Organizing Pneumonia
• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper.
DRUG	Azithromycin	Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months
DRUG	Montelukast	Montelukast 10 mg PO qhs for 3 months
DRUG	Symbicort	Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-12-01
• Completion: 2013-12-30
• First posted: 2011-09-12
• Last updated: 2021-10-20

Locations

1 site across 1 country: Canada