Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.

Chronic Rhinosinusitis With Polyposis Clinical Trial

Official title:

Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687515
• Other study ID #: TR-BIS
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: September 2018
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in the preoperative management of chronic rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 30, 2017
• Est. primary completion date: December 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 64 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis (nasal obstruction, rhinorhea, loss of smell, and headache/facial pain) for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography (CT) scan. The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.

• Bilateral nasal polyps were present and endoscopic biopsy demonstrated eosinophilic polyposis. Patients were not recruited who had large polyps (total Kennedy score=6).

Exclusion Criteria:

• a previous oral corticosteroid treatment.

• recent sinus surgery

• ASA intolerance

• cystic fibrosis

• pregnancy

• serious or unstable concurrent disease or psychological disorder.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Polyposis
• Colorectal Neoplasms
• Nasopharyngeal Neoplasms
• Sinusitis

Intervention

Drug:
• budesonide
1mg/2ml Pulmicort Respules BIS twice daily
• budesonide
nasal spray 256µg BID
• Prednisone
oral prednisone 24mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)	The primary efficacy outcome measure was the patients' assessment of four major symptoms improvement on an ordinal scaled visual analogue score of 0 to 10, where 0 indicates that no symptom is present and 10 signifies the presence of the most severe nasal obstruction, rhinorrhea, alteration in the sense of smell and headache/ facial pain.	2 weeks
Secondary	Physicians' assessment of nasal polyp size reduction	the physicians' assessment of nasal polyp size reduction by endoscopic examination according to Kennedy score (0, no polyps; 1, polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2, polyps reaching below the inferior border of the middle turbinate, but not below the inferior border of the inferior turbinate; 3, large polyps reaching below the inferior turbinate). Bilateral polyp grade was obtained as the sum of the individual grades for the left and right nasal cavities. A total score of 0-6 is possible.	2 weeks