drugset / Trial / NCT01307462

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462 ↗

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2011-06
Primary completion
2014-09
Completion
2015-12

Outcome

Met primary endpoint

paper At 3 months, 6% (2 of 36, 95% confidence interval, 1% to 19%) had treatment failure (versus 40% in historical controls, P < .001). PMID 26475726 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule — Oral
Subject Fluticasone propionate Other / unclassified — Inhaled
Subject Montelukast Other / unclassified — Oral