NCT02177370终止3 期
Effect of Fenoterol Metered Dose Inhaler (0.1 mg) on the Beta-receptor Population on Lymphocytes and the Clinical Findings Compared With Treatment With DSCG Metered Dose Inhaler in Patients With Bronchial Asthma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Airway resistance (Raw)
研究概览
简要总结
The aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •sex: male and female
- •age: 18 years or over
- •bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, PD100SRaw))
- •severity of asthma mild to moderate or asthmatic in symptom-free intervals
- •Raw ≤ 5 cm H2O/l/s
- •no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study
排除标准
- •clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases
- •intercurrent diseases, e.g. severe respiratory infections
- •patients who cannot do without the following preparations during the 5-week trial:
- •inhaled/oral steroids
- •theophylline
- •antihistamine, antiallergic drugs
- •inhaled/oral sympathomimetics
- •anticholinergics
研究组 & 干预措施
Fenoterol metered dose inhaler (MDI)
Experimental
干预措施: Fenoterol MDI (Drug)
DSCG MDI
Active Comparator
干预措施: DSCG MDI (Drug)
结局指标
主要结局
Airway resistance (Raw)
时间窗: after 2 weeks
Number of binding sites of the β2 receptors per lymphocytes (BS/LY)
时间窗: after 2 weeks
次要结局
未报告次要终点
研究者
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