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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Maisonneuve-Rosemont Hospital

Current Primary Outcome: Cumulative incidence of new chronic lung disease [ Time Frame: 6 months following diagnosis of the viral respiratory tract infection ]

The incidence rate of new non-infectious pulmonary complications within the 6 month follow-up period will be calculated. Non-infectious pulmonary complications include new airflow obstruction, new restrictive lung disease, and new mixed obstruction/restriction as measured by spirometry at study enrolment, 2 and 8 weeks following viral infection, and by full pulmonary function tests at 3 and 6 weeks following viral infection.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevalence of non-infectious pulmonary complications [ Time Frame: 6 months following the diagnosis of viral respiratory tract infection ]
    Non-infectious pulmonary complications (NIPCs) include airflow obstruction, restrictive lung disease, and mixed obstruction/restriction as determined by pulmonary function tests. The prevalence of NIPCs will be determined among subjects surviving to 6 months post viral respiratory tract infection.
  • Long-term functional impairment as defined by need for supplemental oxygen [ Time Frame: 6 months post viral respiratory tract infection ]
    The percentage of subjects needing at least 1 month of supplemental oxygen on most days per week, not counting the period of symptomatic viral respiratory tract infection, will be determined in both arms.
  • Patient-perceived long-term functional impairment [ Time Frame: 6 months post viral respiratory tract infection ]
    A FACT-BMT questionnaire will be administered at baseline and again to subjects surviving 6 months post respiratory tract infection to measure patient-perceived functional impairment.
  • Time to clearance of viral infection [ Time Frame: Every 2 weeks until virus is no longer detectable ]
    Subjects in whom a respiratory virus is detected will undergo repeat testing every 2 weeks until the virus is no longer detectable. This is an exploratory analysis. The natural history of many of these community-acquired viruses in the transplant population is not known.
  • Incidence of progression to respiratory failure [ Time Frame: 21 days after enrolment ]
    This endpoint includes admission to hospital because of documented desaturation, need for supplemental oxygen, and need for mechanical ventilation.
  • Incidence of bacterial or fungal superinfection [ Time Frame: Within 21 days after enrolment ]
    The incidence of secondary bacterial and fungal pneumonias will be compared in the two arms, to verify that the added immunosuppression does not contribute to further infectious complications.
  • Incidence of various other infectious complications [ Time Frame: Within 6 months after enrolment ]
    The incidence of various other infectious complications, specifically including but not limited to CMV reactivations and CMV disease, zoster, and septicemia will be monitored in both arms.
  • Overall survival from date of viral respiratory tract infection [ Time Frame: 3 months post enrolment ]
  • Overall survival from date of viral respiratory tract infection [ Time Frame: 6 months post enrolment ]
  • Overall survival from date of transplant to end of study follow-up [ Time Frame: 6 months post enrolment ]
  • Overall survival at 1 year post-transplant [ Time Frame: 1 year post-transplant ]
    This measure will be applied to the group overall and also analyzed according to subgroups of patients presenting viral respiratory tract infections within 30 days of transplant, 31-100 days of transplant, and 101-365 days of transplant.
  • Cumulative incidence of death attributable to transplant associated lung disease [ Time Frame: 6 months post enrolment ]
  • Cumulative incidence of death from other causes [ Time Frame: 6 months post enrolment ]


Original Secondary Outcome: Same as current

Information By: Maisonneuve-Rosemont Hospital

Dates:
Date Received: September 8, 2011
Date Started: September 2011
Date Completion: October 2016
Last Updated: April 8, 2015
Last Verified: April 2015