RDCRN 6503: Targeted Therapy of Bronchiolitis Obliterans Syndrome

Study Status

Open to Enrollment

Study Description

This is a clinical trial for people who have received a hematopoietic cell transplant (HCT) and who have developed Bronchiolitis Obliterans Syndrome (BOS) within the past 3 months.

BOS occurs in 4-8% of HCT patients. BOS makes it very difficult for air to pass through the lungs. The current way to treat BOS is to use high doses of steroids. Long term steroid use can result in bone damage and serious infections. Therefore there is a need to find a better way to treat BOS that does not require high doses of steroids.

This research study is using an experimental combination of 3 drugs called Fluticasone Propionate (brand name Flovent), azithromycin and Montelukast (brand name Singulair). The combination of these drugs is called FAM. 

The purpose of the study is to determine if FAM is effective in treating BOS after allogeneic hematopoietic cell transplant. Fluticasone Propionate and Montelukast are FDA-approved to treat asthma. Azithromycin is FDA-approved antibiotic to treat infections and may have anti-inflammatory effects.

All study participants will take the FAM combination for 6 months. There will be follow-up visits at Months 1, 2, 3 and 6.

Disease Status and/or Stage

Bronchiolitis Obliterans Syndrome (BOS) after Hematopoietic Cell Transplant (HCT)


NIH, GVHD Consortium

Key Eligibility

  • Diagnosis of Bronchiolitis Obliterans Syndrome (BOS) after hematopoietic cell transplant (HCT)
  • BOS diagnosis must be within 3 months before enrolling in the study
  • Prior or current diagnosis of GVHD
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Sebastian Mayer, MD


  • June Greenberg, RN
  • (212) 746-2651
  • [email protected]
  • Bone Marrow Transplant Medical Practice
  • (212) 746-2119

Healthy Volunteers


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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