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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography scan.

• Bilateral nasal polyps were present.

• CRSwNP was defined as eosinophilic when percent of tissue eosinophils exceeded 10% of total infiltrating cells.

• All patients had taken no steroids or antibiotics for at least 4 weeks before sample collection.

Exclusion Criteria:

• cystic fibrosis

• pregnancy

• serious or unstable concurrent disease

• psychological disorder.