Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
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|ClinicalTrials.gov Identifier: NCT03687515|
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Beijing Tongren Hospital
Information provided by (Responsible Party):
Beijing Tongren Hospital
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: Prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 1, 2015|
|Actual Primary Completion Date :||December 3, 2016|
|Actual Study Completion Date :||November 30, 2017|
|Experimental: budesonide inhalation suspension||
1mg/2ml Pulmicort Respules BIS twice daily
|Active Comparator: budesonide aqueous nasal spray||
nasal spray 256μg BID
|Active Comparator: oral steroids||
oral prednisone 24mg QD
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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