EUCTR2004-002983-80-DE进行中（未招募）不适用
Comparison of the Efficacy of a Fixed Combination of Ciclesonide and Formoterol versus a Fixed Combination of Fluticasone and Salmeterol - EXCITED
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
- 150
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
- •- Patients, who are in good health with the exception of asthma, and who have
- •- FEV1 > 60% to < 80% of predicted, when rescue medication has been withheld for at least 6 h before pulmonary function measurement. This applies to all eligible patients, either pre-treated with a constant dose of < or = 500 µg fluticasone (or equivalent) per day only, or pre-treated with a constant dose of < or = 250 µg fluticasone (or equivalent) per day in combination with:
- •-- an inhaled long-acting ß-agonists (LABA) in a fixed or free combination, or
- •-- sustained-release theophylline, or
- •-- a leukotriene antagonist, or
- •-- a lipoxygenase inhibitor, or
- •-- an inhaled anticholinergic, or
- •-- an oral ß-agonist, or
- •-- inhaled disodium cromoglycate, or
- •-- inhaled nedocromil
- •during at least four weeks prior to entry in the study.
- •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 (e.g. abnormal serum potassium and glucose levels) suggesting an unknown disease and requiring further clinical evaluation,
- •- Concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids (ICS) (e.g. active and inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), or contra-indications for the use of long-acting beta2-agonists (LABAs, e.g. di-agnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroid-ism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430ms, female > 450ms) or tachyarrhythmia,
- •- Suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (e.g. infection of lower airways within 4 weeks prior to entry into the study),
- •- Current smoking or cessation of smoking within the last 6 months,
- •- Previous smoking with a smoking history > or = 10 cigarette pack-years,
- •- More than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0
- •Medications:
- •- Use of injectable glucocorticosteroids or oral systemic glucocorticos-teroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months,·
- •- Use of other drugs not allowed and washout times of prohibited drugs cannot be adhered to,
- •- Known or suspected hypersensitivity to ICS, salmeterol, formoterol, lactose monohydrate or to other excipients of the DPI,
- •- Known or suspected hypersensitivity to salbutamol or to excipients of the MDI,
- •- Beginning of immunotherapy within the study period,
- •- Pre-treatment with variable doses of ICS, either alone or in combina-tion with a non-steroidal controller, during the last 4 weeks prior to en-try into baseline period
- •Common criteria:
- •- Pregnancy or intention to become pregnant during the course of the study, breast feeding, or 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 employees at the investigational site,
- •- 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).
研究者
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