Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Overview
- Phase
- Phase 2
- Intervention
- placebo
- Conditions
- Nasal Polyps
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- reduction of nasal polyp size
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Luo Zhang
Director, Beijing Institute of Otolaryngology.
Beijing Tongren Hospital
Eligibility 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.
Arms & Interventions
placebo
Intervention: placebo
budesonide
Intervention: budesonide
Outcomes
Primary Outcomes
reduction of nasal polyp size
Time Frame: from baseline to two weeks
endoscopic polyp scores are assessed pre- and post-treatment.
patients' assessment of symptoms improvement
Time Frame: 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 Outcomes
- remodeling effect of budesonide transnasal nebulization in CRSwNP(from baseline to 2 weeks)
- immunologic effect of budesonide transnasal nebulization in CRSwNP(from baseline to 2 weeks)