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

NCT ID: NCT03687515

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-11-30

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.

Conditions

Chronic Rhinosinusitis With Polyposis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

budesonide inhalation suspension

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

1mg/2ml Pulmicort Respules BIS twice daily

budesonide aqueous nasal spray

Group Type: ACTIVE_COMPARATOR

budesonide

Intervention Type: DRUG

nasal spray 256μg BID

oral steroids

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

oral prednisone 24mg QD

Interventions

budesonide

1mg/2ml Pulmicort Respules BIS twice daily

Intervention Type: DRUG

budesonide

nasal spray 256μg BID

Intervention Type: DRUG

Prednisone

oral prednisone 24mg QD

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TR-BIS

Identifier Type: -

Identifier Source: org_study_id