Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection P… (NCT01432080) | Clinical Trial Compass
TerminatedPhase 2
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
Stopped: Not meeting recruitment targets
Canada12 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Allogeneic transplant within the prior 1 year
* Age greater than or equal to 18 years
* Capable of informed consent
* Neutrophil engraftment has occurred
* This is the first clinically-recognized episode of viral respiratory tract infection after transplant
Exclusion Criteria:
* Proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia
* CMV, VZV or HSV pneumonia
* Prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: BO, COP)
* Treating physician believes the risk of systemic steroids is too great
* Currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid
* Currently receiving pentostatin
* Mycophenolate initiated de novo or increased within the past 4 weeks
* Use of inhaled corticosteroids within the past 2 weeks for at least 1 week
* Haploidentical or T-cell depleted graft
* Lack of pre-transplant pulmonary function tests
* Evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not
* Allergy or adverse reaction to any of the study drugs
* Relapse or progression of the underlying malignancy
* Palliative care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of new chronic lung disease
Timeframe: 6 months following diagnosis of the viral respiratory tract infection