Drug intelligence / Profile preview

fluticasone propionate + azithromycin + montelukast sodium

Development stage
Phase 2
Lead developer
Stephanie Lee
Modality
Small Molecules
Administration
Oral, Inhalation
01

Overview

The FAM regimen is a combination therapy consisting of three distinct pharmacological agents: fluticasone propionate (an inhaled corticosteroid), azithromycin (a macrolide antibiotic), and montelukast sodium (a leukotriene receptor antagonist). This combination was specifically evaluated in a Phase II clinical trial (NCT01307462) led by Dr. Stephanie J. Lee at the Fred Hutchinson Cancer Research Center for the treatment of new-onset bronchiolitis obliterans syndrome (BOS) in patients who have undergone allogeneic hematopoietic cell transplantation. The regimen is designed to halt the progression of BOS, a severe fibro-inflammatory pulmonary complication of chronic graft-versus-host disease (cGVHD). Fluticasone propionate acts locally in the airways to reduce inflammation, azithromycin provides immunomodulatory effects by potentially inhibiting pro-inflammatory cytokines, and montelukast antagonizes leukotriene-mediated bronchoconstriction and inflammation. The trial demonstrated that the FAM regimen, often administered with a brief systemic steroid pulse, could stabilize lung function and reduce the need for prolonged systemic corticosteroid exposure.

Other names
Fluticasone, Azithromycin, and MontelukastFAM regimen
02

Targets

Bacterial 50S ribosomal subunitCYSLTR1 (Cysteinyl-leukotriene type 1 receptor)GR (Glucocorticoid receptor)

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