Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months
研究概览
简要总结
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.
详细描述
General Objective:
- 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:
- Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.
- Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.
- Compare improvements in smell after treatment with prednisone or placebo.
- Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
- 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 .
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Prednisone (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Constanza J. Valdes
MD, Professor Assistant University of Chile. Department of Otorhinolaryngology-Head and Neck Surgery.
University of Chile