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

NCT01432080 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Canadian Blood and Marrow Transplant Group

    collaborator NETWORK

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Elizabeth F Krakow, MD,CM, FRCPC · Maisonneuve-Rosemont Hospital

  • Sandra Cohen, MD, FRCPC · Maisonneuve-Rosemont Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2013-12-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432080 on ClinicalTrials.gov