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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Beijing Tongren Hospital

Current Primary Outcome:

  • 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


Original Primary Outcome: clinical, immunologic and remodeling benefits of budesonide inhalation suspension in nasal polyps [ Time Frame: from baseline to two weeks ]

Nasal symptoms and endoscopic polyp scores are 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 T cell subsets by flow cytometry.


Current Secondary Outcome:

  • immunologic effect of budesonide transnasal nebulization in CRSwNP [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: safety of budesonide via transnasal nebulization in nasal polyps [ Time Frame: from baseline to two weeks ]

Morning corticol level is measured pre- and post-treatment. The incidence and severity of adverse events are recorded during treatment.


Information By: Beijing Tongren Hospital

Dates:
Date Received: December 27, 2013
Date Started: September 2010
Date Completion:
Last Updated: October 9, 2014
Last Verified: October 2014