Comparison of ciclesonide (80 µg or 160 µg once daily in the evening) and fluticasone propionate (100 µg twice daily in the morning and evening) in pediatric asthma patients

ALTANA Pharma AG0 个研究点目标入组 750 人开始时间: 2004年9月29日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- age 6 to 11 years
•- persistent bronchial asthma for at least 6 months
•- FEV1of 50 to 90% for patients using rescue medication only, 80 to 100% for patients using ICS, 50 to 100% for patients using non-ICS controller drugs
•- FEV1 of 50 to 90% of predicted after baseline (at randomization)
•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

•- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
•- History of life-threatening asthma
•- Two or more inpatient hospitalizations for asthma within the last year
•- Asthma exacerbation within the last 30 days
•- Current smoking
•- Use of systemic steroids during the study, within the last 30 days, 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/day FP (CFC/HFA) or equivalent
•- Use of a combination of ICS and other asthma controller drugs within the last 30 days prior to B0
•- Pregnancy
•- Premature birth

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