NCT01198912已完成2 期
Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Endoscopic evaluation of quality and speed of wound healing
研究概览
简要总结
This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age, of either sex and any race
- •diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
- •Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
- •Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
- •Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
- •Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.
排除标准
- •Women must not be pregnant, breast feeding, or premenarcheal.
- •Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
- •Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
- •Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
- •Patients with the following diseases should be excluded :
- •Cystic fibrosis based on positive sweat test or DNA alleles
- •Gross immunodeficiency (congenital or acquired)
- •congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
- •Non-invasive fungal balls and invasive fungal disease
- •systemic vasculitis and granulomatous diseases
- •Cocaine abuse
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
doxycycline 100 mg
Experimental
干预措施: doxycycline 100 mg (Drug)
结局指标
主要结局
Endoscopic evaluation of quality and speed of wound healing
时间窗: at 3 months after first drug intake
Recurrence of nasal polyps
时间窗: at 6 months after first drug intake
次要结局
- nasal and exhaled NO(at 6 months after first drug intake)
- inflammatory mediators in nasal fluid as well as in serum(at 6 months after first drug intake)
- subjective assessment of the wound healing(at 6 months after first drug intake)
- chronic rhinosinusitis symptoms by the patients(at 6 months after first drug intake)
- Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire(at 6 months after first drug intake)
研究者
研究点 (2)
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