EUCTR2005-002462-11-DE进行中（未招募）不适用
Clinical efficacy of different inhalation sequences of Formoterol and Budesonide in asthmatic patients
Pulmonary Research Institute GmbH an der Asklepiosklinik Barmbek. Niederlassung Hamburg.0 个研究点目标入组 20 人开始时间: 2005年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Patients with intermittent or mild persistent asthma, according to the GINA guidelines2.
- •·Male or female patients 18 years of age or older.
- •·FEV1 = 80% of predicted value.
- •·Increased hyper-responsiveness to methacholine with a PC20FEV1 of <4 mg/mL and a PC30FEV1 that leads to a 30% decrease in FEV1 after receiving a maximal concentration of 16 mg/ml methacholine.
- •·One reversibility test with Salbutamol after a dose of 400 µg = 12% increase FEV1 compared to baseline iwithin the last two years.
- •·Exhaled NO concentration above 40 ppb.
- •·Ability to produce sputum after inhalation of hypertonic saline.
- •.Non smoker or ex-smoker with a smoking history of less than 10 pack-years and who have stopped smoking at least 1 year ago.
- •·Understanding of the study and agreement to give written informed consent before the first study visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Pregnant women, nursing mothers or females with childbearing potential, regardless of whether or not they are sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).
- •·History of substance abuse or drug abuse within 12 previous months.
- •·Other respiratory diseases except asthma and allergic rhinitis.
- •·Use of inhaled within the last 6 weeks or oral/systemic steroids of any kind of corticosteroids in the last 3 months.
- •·Recent respiratory infection (upper and lower airways) in the last month prior to V0 .
- •·Asthma exacerbation within 6 weeks prior to inclusion.
- •·Prophylactic vaccinations against infectious agents within the last 4 weeks. (Flu).
- •·Treatment with SIT (specific immuntherapy against aeroallergens).
- •·Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders that may interfere with successful completion of the study.
- •·Participation in an investigational drug study within 30 days prior to visit 1 or current participation in another investigational drug study.
- •·Known sensitivity to the study medication or to any of the excipients contained in any of these formulations.
- •·Patients who take any other medication for their asthma than beta-2-agonists.
- •·Patients with a stage 2 hypertension or higher, that is, patients with systolic values iqual or greater than 160 mmHg or diastolic values iqual or greater than 100 mmHg
- •·Non compliant patients.
研究者
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