EUCTR2007-003736-34-HU进行中（未招募）1 期
Effect of low dose continuous treatment with Ciclesonide over one year on the time to first exacerbation in children with mild asthma versus intermittent treatment for exacerbations - POPCICLE
ycomed Canada Inc.0 个研究点目标入组 240 人开始时间: 2007年7月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •· Patients giving assent and parents/guardians informed consent
- •· Outpatients, male or female, age 4 to 11 years inclusive
- •· Symptoms consistent with the diagnosis of asthma for at least 12 months not requiring the use of an ICS (less or equal to 250mg/day FP or equivalent) for more than 8 weeks within the last 12 months (no ICS 30 days prior to B0)
- •· FEV1 at least 80 % of predicted, measured at least 4 hours after the inhalation of short acting b2-agonist (e.g. salbutamol), or at least 24 hours after the inhalation of a LABA (salmeterol or formoterol), anticholinergics or the oral intake of theophylline or leukotriene antagonists
- •· Ability to perform reproducible lung function tests
- •· With the exception of asthma, are in good health
- •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
- •· History of life-threatening asthma
- •· Hospitalization for asthma within the past 3 months or > or = 2 hospitalizations within the last year.
- •· Asthma exacerbation, or relevant RTI within the last 30 days requiring anti-asthmatic medication beyond an increase in bronchodilator dose
- •· Initiation of immunotherapy within 6 months of B0, or planned initiation within the study period
- •· Severe atopic dermatitis
- •· Concomitant severe diseases or diseases which are contraindicated for the use of ICS
- •· Relevant lung diseases causing alternating impairment in lung function
- •· Prematurely born children (< 36 weeks of gestation)
- •· Conditions [cardiovascular, neurological, hepatic, renal, respiratory (other than asthma or allergic rhinitis), or others] considered as clinically significant
- •· History of cataracts and/or glaucoma
- •· Suspected hypersensitivity to ICS or short-acting ß agonist
- •· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •· Use of systemic corticosteriods for > 30 days within the previous year, or within 30 days (injectable depot steriods 6 weeks) of B0 or more than 3 times during the last 6 months
- •· Use of drugs not allowed or washout times of drugs cannot be adhered to
- •· Need for concomitant medications that interfere with the study
- •· Lung disease other than asthma, concomitant severe disease
- •· Pregnancy, intention to become pregnant during the trial or lack of safe contraception in females of child-bearing potential
- •· Patients who are mentally incapacitated
- •· Suspected non-compliance or inability to follow the procedures of the study
- •· Participation in another trial within 30 days of enrolment, or previous enrolment in current study
- •· Patient or parents relocation during the study, preventing adherence to visit schedule
- •· Parents or legal representative are, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained
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