Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiological Evaluation
研究概览
简要总结
To evaluate the efficacy of Doxycycline as an adjunct to systemic steroids in the treatment of chronic rhinosinusitis with nasal polyps
详细描述
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation. The prevalence of CRSwNP in the general population ranges between 1 and 4%. It mostly affects adult individuals. The treatment of CRSwNP can include the use of steroids, antibiotics, saline nasal spray, mucolytics, topical/systemic decongestants, topical anticholinergics, anti-leukotrienes or receptor blockers, and antihistamines. Steroids have a multitude of effects, including inhibition of cytokine synthesis, reduction of the number of eosinophils and activated eosinophils, anti-oedema effects and reduction of transudation. Topical corticosteroid therapy is not effective in all patients, leading to the use of systemic glucocorticosteroids and/or sinus surgery to control the disease. As a new approach, antibiotics are being used to treat CRSwNP particularly in patients with disease exacerbated by the Staphylococcus aureus enterotoxin. Antibiotics with anti- inflammatory effects can be used to treat patients with chronic rhinosinusitis without polyps, which might be the precursor to CRSwNP. Long-term treatment with these drugs, in selected cases, may be effective when corticosteroids fail. Doxycycline has dual action: it has well described, broad-spectrum antibacterial activity against S aureus as well as anti-inflammatory properties. It appears to be effective in treatment of several chronic inflammatory airway diseases.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Adult patients (aged 18 and over) with bilateral nasal polyps confirmed by nasal endoscopy and CT scan.
排除标准
- •CRS without nasal polyps.
- •Unilateral nasal polyps.
- •Pregnant and lactating women.
- •Patients younger than 18 years old.
- •Subjects with known allergic reaction to steroids or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma, tuberculosis, herpes infection are excluded.
- •If any major complications to the drugs in use appeared in process.
研究组 & 干预措施
Steroids + Doxycycline
Systemic Prednisolone in decreasing doses (40 mg/d on days 1-7, 20 mg/d on days 8-14, and 10 mg/d on days 15-21) along with Doxycycline (200 mg as a loading dose on the 1st day, followed by 100 mg once daily one hour before meal as a maintenance dose) for 3 weeks.
干预措施: Doxycycline 100 mg Oral Tablet (Drug)
Steroids + Doxycycline
Systemic Prednisolone in decreasing doses (40 mg/d on days 1-7, 20 mg/d on days 8-14, and 10 mg/d on days 15-21) along with Doxycycline (200 mg as a loading dose on the 1st day, followed by 100 mg once daily one hour before meal as a maintenance dose) for 3 weeks.
干预措施: Prednisolone 20 mg (Drug)
Steroids Only
Systemic Prednisolone in decreasing doses (40 mg/d on days 1-7, 20 mg/d on days 8-14, and 10 mg/d on days 15-21) for 3 weeks.
干预措施: Prednisolone 20 mg (Drug)
结局指标
主要结局
Radiological Evaluation
时间窗: after 12 weeks from the start of treatment
Multislice computed tomography scan of the nose and paranasal sinuses will be done before starting the treatment and at the end of the follow-up period (12 weeks) using the Lund-Mackay (LMK) scoring system where each sinus (maxillary, anterior ethmoidal, posterior ethmoidal, frontal, sphenoidal) is scored for opacification (0, no opacity; 1, partial opacity; 2, total opacity), and the osteo-meatal complex is scored 0 (no obstruction) or 2 (obstruction). The unilateral score goes from 0 to 12 whereas the bilateral score goes from 0 to 24
Polyp Size Score by Nasal Endoscopy
时间窗: after 12 weeks from the start of treatment
Every patient will undergo nasal endoscopy at the initial visit and every follow-up visit using a modified Lildholdt scoring system and given scores from 0 to 4. The total nasal polyp score is the sum of the scores from the right and left nostrils. 0 = No polyps. 1. = Small polyps in the middle meatus not reaching below the inferior border of the middle concha. 2. = Polyps reaching below the lower boarder of the middle turbinate. 3. = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha. 4. = Large polyps causing almost complete obstruction of the inferior meatus.
次要结局
- Laboratory Measures(after 12 weeks from the start of treatment)
- Symptomatology(after 12 weeks from the start of treatment)
研究者
Mai Essam Ali AbuElmagd
Residant
Assiut University