Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant

Status: Recruiting
Phase: Phase 2
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01307462 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-417


This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Vincent Ho, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Kimberly Phillips, kimberly_phillips@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - New diagnosis of BOS after HCT within 3 months of study enrollment - The baseline absolute FEV1 must be >= 10% lower than the pre-transplant FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1 - Life expectancy > 6 months at the time of enrollment as judged by the enrolling investigator - All females of childbearing potential must have a negative serum or urine pregnancy test =< 7 days before study drug administration - Subject (or parent/guardian) has the ability to understand and willingness to sign a written consent document Exclusion Criteria: - Patients with recurrent malignancy or disease progression requiring anticancer therapy - Known history of allergy to montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin - Pregnant females or nursing mothers - Transaminases > 5 X upper limit of normal (ULN) - Total bilirubin > 3 X ULN - Patients currently on daily inhaled steroid (with any inhaled steroid equivalent to fluticasone) for > 1 month preceding enrollment - Patients currently on montelukast for > 1 month preceding enrollment - Patients currently on chronic dosing of azithromycin (>= 3 x/week) for > 1 month preceding enrollment; patients that have taken a Z-pak or other macrolides to treat infection are eligible - Patients requiring > 1.2 mg/kg/day of prednisone (or equivalent steroid) - Receipt of any non-Food and Drug Administration (FDA) approved study medication within the last 4 weeks (this does not apply to use of FDA-approved drugs for an off-label indication) - Evidence of any viral, bacterial or fungal infection not responding to appropriate treatment - Patients with clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness) - Patient with any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements - Patients on long-term oxygen therapy - Patients with uncontrolled substance abuse or psychiatric disorder - Patients who are deemed (by the local principal investigator [PI] or the pulmonary function test [PFT] lab) unable to reliably perform pulmonary function tests
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