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

Maisonneuve-Rosemont Hospital

Status and phase: Terminated; Phase 2

Conditions: Bronchiolitis Obliterans; Lung Diseases, Interstitial; Cryptogenic Organizing Pneumonia; Respiratory Tract Infections

Treatments: Drug: Prednisone; Drug: Azithromycin; Drug: Montelukast; Drug: Symbicort

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01432080

HMR1102

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Standard of Care includes fluids, antipyretics, ribavirin for RSV infection, and oseltamivir for influenza infection, and intravenous immune globulin for patients with low IgG levels.

SAMS

Experimental group

Description:

Subjects randomized to the SAMS arm will receive a four-drug combination (Steroids, Azithromycin, Montelukast, and Symbicort).

Treatment:

Drug: Symbicort

Drug: Azithromycin

Drug: Montelukast

Drug: Prednisone