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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| budesonide | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| safety of budesonide via transnasal nebulization in nasal polyps | Morning corticol level is measured pre- and post-treatment. The incidence and severity of adverse events are recorded during treatment. | from baseline to 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang, MD | Beijing Institute of Otolaryngology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo | Other | patients receive placebo (saline solution) 2ml twice daily for 14 days. |
|
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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |