Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with
eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation
suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic
polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp
samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and
tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry;
and frequencies of different inflammatory T cell infiltration by flow cytometry. this study
is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation
suspension via transnasal nebulization by clinical and immunologic assessments. As outcome
parameters for remodeling, differences in the expression of collagen and albumin were
investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs
expression differences in nasal polyps were investigated to explore underlying mechanisms of
tissue reconstitution.