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

NCT02024659 | Completed Phase 2 DMC

• 1 other identifier: TongRen-BJO
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

nasal polyps; remodeling; inflammatory cells; budesonide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• immunologic effect of budesonide transnasal nebulization in CRSwNP

  from baseline to 2 weeks

• remodeling effect of budesonide transnasal nebulization in CRSwNP

  from baseline to 2 weeks

Other Outcomes (1)

• safety of budesonide via transnasal nebulization in nasal polyps

  from baseline to 2 weeks

Study Arms (2)

budesonide

EXPERIMENTAL

Drug: budesonide

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

budesonide DRUG

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

budesonide

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• cystic fibrosis
• pregnancy
• serious or unstable concurrent disease
• psychological disorder.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luo Zhang, MD

  Beijing Institute of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Beijing Institute of Otolaryngology.

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2014
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

CN (1)