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Investigator(s):
Kirsten M. Williams, M.D Phone: 301-435-6456 Fax: 301-480-4354 williaki@mail.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• New diagnosis of bronchiolitis obliterans syndrome (BOS) after hematopoietic cell transplantation (HCT) within 3 months of study enrollment
• ≥ 6 years of age
• The baseline absolute FEV1 must be ≥ 10 percent lower than the pre-transplant FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1
• Transaminases ≤ 5 X upper limit of normal (ULN)
• Total bilirubin ≤ 3 X ULN
• No known history of allergy to montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin
• Not pregnant or breast feeding

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Study Outline:

• Screening with a physical examination, medical history, lung function test, blood and urine tests, and a 6-minute walking test to measure shortness of breath
• Participants will take the FAM drug combination:
• Fluticasone is inhaled by mouth twice a day
• Azithromycin and montelukast are pills taken on a regular weekly schedule
• At 1 and 2 months after the start of the study, clinic visits to review medication use and have lung function tests
• At 3 and 6 months after the start of the study, clinic visits with blood and urine tests, lung function tests, and a 6-minute walking test

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 5/11/12