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

• Sponsor: Beijing Tongren Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03687515
• Collaborator: (none)
• Enrollment: 91
• Arms: 3
• Actual Duration (Months): 35

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis With Polyposis	Drug: budesonide; Drug: budesonide; Drug: Prednisone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 3, 2016
• Actual Study Completion Date: Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: budesonide inhalation suspension	Drug: budesonide; 1mg/2ml Pulmicort Respules BIS twice daily
Active Comparator: budesonide aqueous nasal spray	Drug: budesonide; nasal spray 256μg BID
Active Comparator: oral steroids	Drug: Prednisone; oral prednisone 24mg QD

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beijing Tongren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Tongren Hospital
• ClinicalTrials.gov Identifier: NCT03687515
• Other Study ID Numbers: TR-BIS
• First Posted: Sep 27, 2018
• Last Update Posted: Sep 27, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sinusitis; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Prednisone; Budesonide

Study Results

No Results Posted as of Sep 27, 2018