EUCTR2004-001838-16-HU进行中（未招募）1 期
Efficacy and safety of a fixed combination of ciclesonide and formoterol once or twice daily in the treatment of persistent asthma A randomized, double-blind, placebo-controlled, parallel-group, multi-center study - EFFORT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 810
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
- •- written informed consent,
- •- male or female outpatients,
- •- age 12 to 75 years,
- •- history of bronchial asthma for at least 6 months,
- •- good health, with the exception of asthma
- •Depending on the individual pre-treatment, additionally one of the following criteria must be met at B0:
- •In patients pre-treated with <= 250 µg fluticasone propionate (or equivalent) per day only and at constant dosage during at least four weeks prior to entry in the study, the FEV1 has to be > 60% to < 80% of predicted when rescue medication has been withheld for at least 6 h.
- •In patients pre-treated with <= 250 µg fluticasone propionate (or equivalent) per day in combination with:
- •- an inhaled LABA in a fixed or free combination, or
- •- sustained-release theophylline, or
- •- a leukotriene antagonist, or
- •- a lipoxygenase inhibitor, or
- •- an oral beta-agonist,
- •at constant dosage during at least four weeks prior to entry into the study, the FEV1 has to be >= 80% of predicted when rescue medication has been withheld for at least 6 h.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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), or contraindications for the use of LABAs (e.g. diagnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, thyrotoxicosis, phaeocromocytoma, hypokalaemia, prolonged QTc interval (male > 430 ms, female > 450 ms), or tachyarrhythmia),
- •- suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or ephysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (infection of lower airways within 4 weeks prior to entry into the study),
- •- clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (e.g. abnormal serum potassium and glucose levels),
- •- current smoking,·
- •- previous smoking with a smoking history >= 10 cigarette pack-years,
- •- use of injectable or oral systemic steroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months,
- •- use of other prohibited drugs and washout times of prohibited drugs cannot be adhered to,
- •- known or suspected hypersensitivity to ICS, to formoterol, to the excipient lactose monohydrate, or to other excipients of the DPI,
- •- known or suspected hypersensitivity to salbutamol or to excipients of the metered dose inhaler (MDI),
- •- beginning of immunotherapy within the study period,
- •- pre-treatment with variable doses of ICS, either alone or in combination with a non-steroidal controller, during the last 4 weeks prior to baseline,
- •- pregnancy,
- •- intention to become pregnant during the course of the study,
- •- breast feeding,
- •- lack of safe contraception in women of child-bearing potential,
- •- participation in another study within the 30 days preceding and during the present study,
- •- previous enrolment into the current study,
- •- enrolment of the investigator, his/her family members, or his/her employees,
- •- reversal of sleep pattern (e.g. night shift workers),
- •- inability to follow the procedures of the study; e.g. due to language problems, psychological disorders,
- •- known or suspected non-compliance, alcohol or drug abuse
研究者
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