ISRCTN07852892已完成不适用
Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent sputum: a double-blind randomised controlled clinical trial
Primary Care Research Institute Jordi Gol i Gurina (Institut d?Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)0 个研究点目标入组 420 人开始时间: 2011年3月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients from 18 to 70 years of age without associated respiratory comorbidity or immunosuppression will be recruited from seven healthcare centers in Catalonia.
- •1. Presenting respiratory infection of at least one week of evolution
- •2. Cough as the predominant symptom
- •3. Presence of purulent expectoration of at least one week of duration
- •4. At least one other respiratory tract symptom such as dyspnoea, wheezing, chest discomfort or pain, with no alternative explanation such as pneumonic condensation
排除标准
- •1. Patients less than 18 and older than 70 years of age
- •2. Presence of radiological signs of pneumonia
- •3. Signs of severe infection
- •3.1. confusion
- •3.2. tachypnoea > 25 respirations per minute of tachycardia > 120 beats per minute
- •4. History of digestive haemorrhage or intolerance to anti-inflammatory treatment
- •5. Hypersensitivity to ß-lactam or intolerance to clavulanic acid or lactose
- •6. Pregnancy, lactation and women of fertile age not using contraceptive measures
- •7. Antibiotic, anti-inflammatory or corticoid use in the previous two weeks
- •8. Associated comorbidity
- •8.1. bronchial asthma
- •8.2. chronic obstructive pulmonary disease
- •8.3. moderate-severe heart failure
- •8.4. dementia
- •8.5. stroke
- •8.6. immunosupression or the use of immunosuppressive drugs
- •9. Emergency situation
- •10. Institutionalisation in a residence
- •11. And/or subjects unable to personally provide informed consent
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