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

Phase 2

Completed

• Conditions: Nasal Polyps
• Interventions: Other: placebo; Drug: budesonide

• Registration Number: NCT02024659
• Lead Sponsor: Beijing Tongren Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-12
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Study Completion: 2014-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
budesonide	budesonide	-

Primary Outcome Measures

Name	Time	Method
reduction of nasal polyp size	from baseline to two weeks	endoscopic polyp scores are assessed pre- and post-treatment.
patients' assessment of symptoms improvement	from baseline to two weeks	Four major symptoms, including nasal obstruction, discharge, loss of smell, headache/ facial pain, and TNSS were assessed by the patient pre- and post-treatment

Secondary Outcome Measures

Name	Time	Method
remodeling effect of budesonide transnasal nebulization in CRSwNP	from baseline to 2 weeks	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
immunologic effect of budesonide transnasal nebulization in CRSwNP	from baseline to 2 weeks	Polyp samples were evaluated for inflammatory cytokines, mediators and cellular infiltration pre- and post-treatment.

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China