Clinical trial NCT02024659: Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps
Official title: Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nasal Polyps
Keywords: nasal polyps
remodeling
inflammatory cells
budesonide
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: reduction of nasal polyp size
timeFrame: from baseline to two weeks
measure: patients' assessment of symptoms improvement
timeFrame: from baseline to two weeks
Secondary outcomes:
measure: immunologic effect of budesonide transnasal nebulization in CRSwNP
timeFrame: from baseline to 2 weeks
measure: remodeling effect of budesonide transnasal nebulization in CRSwNP
timeFrame: from baseline to 2 weeks
Other outcomes:
measure: safety of budesonide via transnasal nebulization in nasal polyps
timeFrame: from baseline to 2 weeks
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Institute of Otolaryngology
name: Luo Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: