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

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024659
• Other study ID #: TongRen-BJO
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 27, 2013
• Last updated: October 9, 2014
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps

Intervention

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

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

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	reduction of nasal polyp size	endoscopic polyp scores are assessed pre- and post-treatment.	from baseline to two weeks	No
Primary	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	No
Secondary	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	No
Secondary	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	No