NL-OMON43072已完成4 期
Infection prevention and immune modulation by bacterial lysates in patients with asthma: gaining insight into the mechanism of an old therapy - BREATHE
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 < 8 mg/ml)) who have recurrent airway signs and symptoms despite optimal maintenance medication (medium/high dose inhalation corticosteroid and long-acting *2-agonist; GINA 4).;Specific inclusion criteria
- •- * 2 documented asthma exacerbations in the past winter season (see definition below)
- •- and Asthma Control Questionnaire (ACQ) > 1.5 despite maintenance medication
排除标准
- •- Other relevant respiratory conditions, e.g. OSAS, bronchiectasis
- •- Systemic immunological diseases
- •- Current smoking or past smoking 10 pack years
- •- Other untreated co-morbidity, such as gastro-esophageal reflux disease, ENT problems, psychological disorders
- •- Non-compliance to current medication or inhalation technique
- •- Communication difficulties
- •- Pregnancy or planned pregnancy within 2 years
研究者
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