Prednisone in Chronic Rhinosinusitis Without Nasal Polyps

Phase 3

• Conditions: Sinusitis; Chronic Rhinosinusitis
• Interventions: Drug: Placebo; Drug: Prednisone

• Registration Number: NCT02367118
• Lead Sponsor: University of Chile

Brief Summary

The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

Detailed Description

General Objective:

1. Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.

Specific Objectives:

1. Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.

2. Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.

3. Compare improvements in smell after treatment with prednisone or placebo.

4. Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.

5. Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .

6. Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-20
• Status Verified: 2015-06
• Study Start: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012

Read More

Exclusion Criteria

• Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
• Previous surgical treatment for CRSsNP
• History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.
• Pregnancy.
• History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
• Hypersensitivity to prednisone

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days.
Prednisone	Prednisone	Intervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days.

Primary Outcome Measures

Name	Time	Method
Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months	Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months	Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months	Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months	Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo

Trial Locations

Locations (1)

Hospital del Salvador; 🇨🇱 Santiago, Region Metropolitana, Chile