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

NCT ID: NCT02024659

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

budesonide

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

budesonide

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luo Zhang

Director, Beijing Institute of Otolaryngology.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luo Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Institute of Otolaryngology

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TongRen-BJO

Identifier Type: -

Identifier Source: org_study_id