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

Phase 3

Completed

• Conditions: Chronic Rhinosinusitis With Polyposis
• Interventions: Drug: budesonide; Drug: Prednisone

• Registration Number: NCT03687515
• Lead Sponsor: Beijing Tongren Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-12-03
• Study Completion: 2017-11-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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).

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Exclusion Criteria

• a previous oral corticosteroid treatment.
• recent sinus surgery
• ASA intolerance
• cystic fibrosis
• pregnancy
• serious or unstable concurrent disease or psychological disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
budesonide inhalation suspension	budesonide	-
oral steroids	Prednisone	-
budesonide aqueous nasal spray	budesonide	-

Primary Outcome Measures

Name	Time	Method
Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Physicians' assessment of nasal polyp size reduction	2 weeks	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.