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

Phase 3CompletedNCT02024659

Beijing Tongren Hospital57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nasal Polyps

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

reduction of nasal polyp size

endoscopic polyp scores are assessed pre- and post-treatment.

Time frame: from baseline to two weeks

patients' assessment of symptoms improvement

Four major symptoms, including nasal obstruction, discharge, loss of smell, headache/ facial pain, and TNSS were assessed by the patient pre- and post-treatment

Time frame: from baseline to two weeks

Secondary Outcomes

immunologic effect of budesonide transnasal nebulization in CRSwNP

Polyp samples were evaluated for inflammatory cytokines, mediators and cellular infiltration pre- and post-treatment.

Time frame: from baseline to 2 weeks

remodeling effect of budesonide transnasal nebulization in CRSwNP

Albumin, collagen,TGF-beta, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) were measured in tissue homogenate at baseline and after 2-week treatment