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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nasal Polyps

Intervention / Treatment
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* Drug: budesonide
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: budesonide<br> | Drug: budesonide<br>* Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* patients receive placebo (saline solution) 2ml twice daily for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of nasal polyp size | endoscopic polyp scores are assessed pre- and post-treatment. | 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 | from baseline to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunologic effect of budesonide transnasal nebulization in CRSwNP | Polyp samples were evaluated for inflammatory cytokines, mediators and cellular infiltration pre- and post-treatment. | 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 | from baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal polyps, remodeling, inflammatory cells, budesonide