Nasal Polyps
Conditions
Keywords
nasal polyps, remodeling, inflammatory cells, budesonide
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.
Interventions
DRUGbudesonide
Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.
OTHERplacebo
patients receive placebo (saline solution) 2ml twice daily for 14 days.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| safety of budesonide via transnasal nebulization in nasal polyps | from baseline to 2 weeks | Morning corticol level is measured pre- and post-treatment. The incidence and severity of adverse events are recorded during treatment. |
Countries
China
Outcome results
None listed