NCT02024659

Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps

Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	budesonide	Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.
OTHER	placebo	patients receive placebo (saline solution) 2ml twice daily for 14 days.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2014-01-01
• First posted: 2013-12-31
• Last updated: 2014-10-10

Locations

1 site across 1 country: China