EUCTR2005-002163-84-DE进行中（未招募）不适用
Comparison of the Efficacy and Safety of 160 µg Ciclesonide Administered Once Daily in the Evening with or without Different Spacer Types in Patients with AsthmaA randomized, open-label, three-arm, parallel group study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 560
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 persistent bronchial asthma (as defined by GINA 2004) for at least 6 months,
- •· good health with the exception of asthma,
- •· currently treated with
- •- either rescue medication only i.e. short-acting beta-agonists (either as monotherapy or as a fixed combination with an anticholinergic), or long-acting beta-agonists,
- •-or with inhaled steroids with a maximum daily dosage of 250 µg fluticasone propionate or equivalent
- •- or with other anti-inflammatory asthma drugs than inhaled steroids, i.e. leukotriene antagonists, xanthine derivates, inhaled cromones, lipoxygenase inhibitors,
- •- or with a fixed or concurrent combination of an inhaled steroid (up to 125µg/day FP or equivalent) and a long-acting ß-agonist or other asthma controllers
- •at a constant dose for the last 4 weeks directly prior to baseline.
- •· FEV1 must meet one of the following rules:
- •- either FEV1=61 - 90% of predicted in patients treated with rescue medication only,
- •- or FEV1=81 - 105% of predicted in patients treated with inhaled steroids alone or in combination with a long-acting ß-agonist or other asthma controller,
- •- or FEV1=61 - 105% in patients treated with other anti-inflammatory asthma drugs than inhaled steroids.
- •FEV1 and FVC have to be measured at least 4 hours after the last use of short-acting beta-agonists and fixed combinations of short-acting beta-agonists and anticholinergics and at least 24 hours after the last use of long-acting beta-agonists.
- •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
- •Diseases and health status:
- •· clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation,
- •· concomitant severe diseases or diseases which are contraindica-tions for the use of inhaled steroids (e. g. active or inactive 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 pulmonary function,
- •· smoking history with = 10 cigarette pack-years (= 2 pipe pack-years)
- •Medication:
- •· use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months,
- •· treatment with inhaled steroids
- •- in dosages higher than listed in the inclusion criteria,
- •- or fluctuating doses of ICS
- •during the 4 weeks directly prior to baseline
- •· use of other drugs not allowed,
- •· washout times of drugs cannot be adhered to,
- •· known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDI,
- •· intolerance to salbutamol or to other excipients of the MDI,
- •· beginning of immunotherapy during the patient´s participation in the study, or having begun an immunotherapy less than three months prior to enrolment, or alternation in regimen of an immunotherapy during the study period.
- •Common criteria:
- •· pregnancy,
- •· intention to become pregnant during the course of the study,
- •· breast feeding,
- •· lack of safe contraception,
- •· 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, employees and other dependent persons,
- •· known or suspected non-compliance, alcohol or drug abuse,
- •· inability to follow the procedures of the study, e.g. due to lan-guage 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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