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

Capital Medical University

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis With Polyposis

Treatments: Drug: Prednisone; Drug: budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT03687515

TR-BIS

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 23 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

budesonide inhalation suspension

Experimental group

Treatment:

Drug: budesonide

Drug: budesonide

budesonide aqueous nasal spray

Active Comparator group

Treatment:

Drug: budesonide

Drug: budesonide

oral steroids

Active Comparator group

Treatment:

Drug: Prednisone