EUCTR2004-001072-39-DE进行中（未招募）不适用
Comparison of Ciclesonide (80 µg Once Daily in the Evening) and Fluticasone propionate (100 µg Twice Daily) in Patients with Mild to Moderate Asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
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
- •- Male and female outpatients aged 12 to 75 years inclusive
- •- written informed consent
- •- history of bronchial asthma for at least 6 months
- •- good health with the exception of asthma
- •- treated with inhaled steroids with a maximum daily constant dosage of 250 µg fluticasone propionate or equivalent during the last 4 weeks di-rectly prior B0
- •- FEV1 = 80 - 105% of predicted
- •Are the trial subjects under 18? yes
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Diseases and health status:
- •- clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •- concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e. g. active pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
- •- suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function,
- •- current smoking with > 10 pack-years,·previous smoking with > 10 pack-years.
- •b)Medication
- •- use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times during the last 6 months
- •- use of other drugs not allowed (see 7.4)
- •- washout times of drugs defined under 7.4 cannot be adhered to
- •- known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDIs
- •- intolerance to salbutamol or to other excipients of the MDI
- •- beginning of immunotherapy within the study period (exception: Pa-tients who are undergoing immunotherapy for at least 3 months are eligible provided the regimen remains the same throughout the trial).
- •c) Common criteria:
- •- pregnancy
- •- intention to become pregnant during the course of the study
- •- breast feeding
- •- lack of safe contraception: Female patients of childbearing potential, not using and not will-ing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implant-able contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/ hysterectomized or post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- •- participation in another study within the 30 days preceding and during the present study
- •- previous enrollment into the current study
- •- enrollment of the investigator
- •- known or suspected non-compliance, alcohol or drug abuse,
- •- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
- •- reversal of sleep pattern (e.g. night shift workers)
- •- intention to relocate during the course of the study, preventing adherence to visit schedule
研究者
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