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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Polyps
• Intervention / Treatment: Drug: budesonide; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Luo Zhang, MD, Beijing Institute of Otolaryngology

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 27, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: budesonide; remodeling; nasal polyps; inflammatory cells
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Nasal Polyps; Polyps; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: TongRen-BJO