Chronic Rhinosinusitis, Sinusitis
Conditions
Keywords
chronic rhinosinusitis without nasal polyps prednisone
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.
Interventions
DRUGPrednisone
DRUGPlacebo
Sponsors
Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 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 |
Countries
Chile
Contacts
Primary ContactConstanza J Valdes, MD
Backup ContactMarcela A Veloz, MD
Outcome results
None listed