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

Information source: Maisonneuve-Rosemont Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Respiratory Tract Infections; Bronchiolitis Obliterans; Cryptogenic Organizing Pneumonia; Lung Diseases, Interstitial

Intervention: Prednisone (Drug); Azithromycin (Drug); Montelukast (Drug); Symbicort (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Maisonneuve-Rosemont Hospital

Official(s) and/or principal investigator(s):
Elizabeth F Krakow, MD,CM, FRCPC, Principal Investigator, Affiliation: Maisonneuve-Rosemont Hospital
Sandra Cohen, MD, FRCPC, Principal Investigator, Affiliation: Maisonneuve-Rosemont Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Cumulative incidence of new chronic lung disease

Secondary outcome:

Prevalence of non-infectious pulmonary complications

Long-term functional impairment as defined by need for supplemental oxygen

Patient-perceived long-term functional impairment

Time to clearance of viral infection

Incidence of progression to respiratory failure

Incidence of bacterial or fungal superinfection

Incidence of various other infectious complications

Overall survival from date of viral respiratory tract infection

Overall survival from date of viral respiratory tract infection

Overall survival from date of transplant to end of study follow-up

Overall survival at 1 year post-transplant

Cumulative incidence of death attributable to transplant associated lung disease

Cumulative incidence of death from other causes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont), Montreal, Quebec H1T 2M4, Canada
Additional Information

Maisonneuve-Rosemont Hospital's Stem Cell Transplant Program

Starting date: September 2011
Last updated: April 8, 2015

Page last updated: August 23, 2015

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