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

September 25, 2018 updated by: Beijing Tongren Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians' assessment of nasal polyp size reduction
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 3, 2016

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-BIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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