Clinical trial NCT02367118: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
Official title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sinusitis
Chronic Rhinosinusitis
Keywords: chronic rhinosinusitis without nasal polyps prednisone
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
First posted: 2015-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months
timeFrame: 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
measure: Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months
timeFrame: 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
measure: Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months
timeFrame: 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
measure: Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital del Salvador
state: Region Metropolitana
Study officials:
affiliation: University of Chile
name: Constanza J Valdes, MD
role: STUDY_DIRECTOR
affiliation: University of Chile
name: Marcela A Veloz, MD
role: PRINCIPAL_INVESTIGATOR
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