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

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02024659

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Polyps	Drug: budesonide Other: placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: budesonide

Drug: budesonide

Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.

Placebo Comparator: placebo

Other: placebo

patients receive placebo (saline solution) 2ml twice daily for 14 days.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.