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Targeted Therapy of Bronchiolitis Obliterans Syndrome
Not Recruiting
Trial ID: NCT01307462
Purpose
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
Official Title
Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant
Stanford Investigator(s)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Judith Shizuru
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
* Diagnosis of BOS after HCT within the 6 months before study enrollment; for this study, BOS is defined as:
* Forced expiratory volume in 1 second (FEV1) \< 75% of the predicted normal and FEV1 to slow or inspiratory vital capacity ratio (FEV1/SVC or FEV1/IVC) =\< 0.7, both measured before and after administration of bronchodilator OR
* Pathologic diagnosis of BOS demonstrated by lung biopsy
* The baseline absolute FEV1 must be \>= 10% lower than the pre-transplant absolute FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1, both measured before administration of a bronchodilator
* Participant (or parent/guardian) has the ability to understand and willingness to sign a written consent document
Exclusion Criteria:
* Recurrent or progressive malignancy requiring anticancer treatment
* Known history of allergy to or intolerance of montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin
* Pregnancy or nursing; all females of childbearing potential must have a negative serum or urine pregnancy test \< 7 days before study drug administration
* Transaminases \> 5 X upper limit of normal (ULN)
* Total bilirubin \> 3 X ULN
* Chronic treatment with any inhaled steroid for \> 1 month in the past three months
* Treatment with montelukast or zafirlukast for \> 1 month during the past three months
* Treatment with prednisone at \> 1.2 mg/kg/day (or equivalent steroid)
* Treatment with rifampin or phenobarbital, aspirin at doses \> 325 mg/day, or ibuprofen at doses \> 1200 mg/day
* Treatment with any Food and Drug Administration (FDA) non approved study medication within the past 4 weeks; off-label treatment with an FDA-approved medication is allowed
* Chronic oxygen therapy
* Evidence of any viral, bacterial or fungal infection involving the lung and not responding to appropriate treatment
* Clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness)
* Any condition that, in the opinion of the enrolling investigator, would interfere with the subject's ability to comply with the study requirements
* Uncontrolled substance abuse or psychiatric disorder
* Inability to perform pulmonary function tests (PFT) reliably, as determined by the enrolling investigator or PFT lab
* Life expectancy \< 6 months at the time of enrollment as judged by the enrolling investigator
* Baseline post-bronchodilator FEV1 \< 20% of predicted normal before or after albuterol
Intervention(s):
drug: Azithromycin
drug: fluticasone propionate
drug: montelukast sodium
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822