EUCTR2006-000803-40-DE进行中（未招募）不适用
A comparative study of inhaled ciclesonide versus placebo in children with asthma (RAINBOW) - RAINBOW
ycomed GmbH0 个研究点目标入组 1,050 人开始时间: 2006年6月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
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 or female outpatients aged 6 to 11 years,
- •- History of persistent bronchial asthma (as defined by GINA 2004 criteria) for at least 6 months,
- •- Ability to perform reproducible pulmonary function tests,
- •- Ability to show optimal use of MDI, including inhalation technique,
- •- Either treatment with rescue medication prn only or treatment with ICS (not exceeding 200 µg/d fluticasone propionate [FP] or equivalent), or treatment with a non-ICS controller drug (e.g., cromones, xanthines, leukotriene antagonists, lipoxygenase inhibitors. or inhaled long-acting ß2-agonists [LABA]), respectively, at a constant dose over the last 30 days directly prior to B0,
- •- PEF (% of predicted value) measured by spirometry at least 4 hours after inhalation of rescue medication (e.g. a short-acting ß2-agonist [SABA]), and at least 24 hours after the use of LABA, xanthines, or oral bronchodilators:
- •- 40% - 90% for patients using rescue medication only,
- •- 50% - 100% for patients using ICS,
- •- 50% - 100% for patients using non-ICS controller drugs.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •The presence of any one of the following will cause exclusion of the patient:
- •a) Diseases and health status:
- •- Concomitant severe diseases,
- •- Diseases which are contraindications for the use of ICS (e. g. active or inactive pulmonary tuberculosis, or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment),
- •- Chronic obstructive pulmonary disease (COPD; i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function,
- •- Respiratory tract infection or asthma exacerbation within the last 30 days prior to B0 as well as during baseline,
- •- Two or more inpatient hospitalizations for asthma within the last year (with the exception of hospitalizations for diagnostic reasons),
- •- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation,
- •- History of life-threatening asthma (i.e. prior intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercarbia in the setting of an asthma exacerbation),
- •- Premature birth (i.e. < 36 weeks gestation),
- •- Current smoking,
- •- Smoking history with either equal or more than 10 pack-years (equal or more than 2 pipe pack-years).
- •b) Medications:
- •- Use of systemic steroids within the last 30 days (injectable depot steroids 6 weeks) prior to B0 or for more than 60 days within the last 2 years,
- •- Use of ICS within the last 30 days prior to B0 at doses higher than 200 µg/d FP or equivalent,
- •- Use of a fixed or free combination of ICS and a non-ICS controller drug within the last 30 days prior to B0,
- •- Use of other drugs not allowed during the study or non-adherence to the given withhold times prior to B0,
- •- Regular use of rescue medication for prophylactic reasons,
- •- Known or suspected hypersensitivity to ICS and/or to excipients of the CIC MDI,
- •- Known or suspected hypersensitivity to salbutamol and/or to excipients of the MDI,
- •- Beginning of or change in immunotherapy within the last 6 months prior to B0 and during the study period,
- •- Use of concomitant medication, which is contraindicated for patients with bronchial asthma.
- •c) Other criteria:
- •- Pregnancy,
- •- Intention to become pregnant during the course of the study,
- •- Breast feeding,
- •- Lack of safe contraception (in all females > or = 10 years of age or post-menarchal):
- •Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized, 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,
- •- Known or suspected non-compliance, alcohol or drug abuse,
- •- Inability to follow the procedures of the study, due to e.g. language problems, psychological disorders,
- •- Patient’s parent(s)/legal guardian(s) is(are), in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained,
- •- Patient or parent(s)/legal guardian(s) intend(s) to relocate during the course of the study, preventing adherence to visit schedule.
研究者
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