Targeted Therapy of Bronchiolitis Obliterans Syndrome

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

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : fluticasone propionate
  • drug : montelukast sodium
  • drug : Azithromycin
  • genetic : protein analysis
  • other : laboratory biomarker analysis
  • other : questionnaire administration
  • procedure : quality-of-life assessment
  • procedure : pulmonary function testing

Phase: Phase 2

Eligibility

Ages Eligible For Study:

6 Years - N/A

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

External Links

Stanford Medicine Resources:

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