EUCTR2006-000253-21-DE进行中（未招募）不适用
Reaching asthma control with salmeterol/fluticasone 50 / 250µg bd combination in steroid naive or low dose JCS patients by using the asthma control test (ACT) as measurement.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •A patient must not be included in the clinical trial unless the following inclusion criteria are met at visit 1:
- •The patient’s written consent statement for participation in the study is available.
- •Male and female patients > 18 years of age with the diagnosis of perennial bronchial asthma.
- •No prior treatment with oral steroids during the last 4 weeks preceding visit 1.
- •In case of prior treatment with inhaled steroids during the last 4 weeks preceding visit 1, the following limits shall apply: BDP < 500 µg/d, fluticasone < 200 µg/d, budenoside < 400 µg/d, ciclesonide < 200 µg/d, and mometasone < 200 µg/d.
- •No changes in the asthma medication during the last 4 weeks preceding visit 1.
- •Reversibility testing: > 12% improvement in FEV1 from baseline after inhaling 200 µg salbutamol.
- •The patient is prepared to replace his/her prior asthma medication during the treatment phase by the salmeterol/fluticasone combination preparation (50/250 µg) b.i.d from the Diskus® inhaler and use the CFC-free Sultanol® metered dose inhaler on a p.r.n. basis.
- •P.r.n. use of short-acting beta-sympathomimetics or short-acting anticholinergics during the screening phase.
- •The patient is prepared to perform daily PEF measurements and keep a diary.
- •Women are only eligible for participation in the study if they
- •a.are not of childbearing potential
- •b.are of childbearing potential, but have a negative (urine) pregnancy test at visit 1 and agree to use contraceptive measures (including abstinence) suitable to prevent pregnancy during the study.
- •Permissible methods of contraception are:
- •Complete abstinence from sexual intercourse for the duration of the study
- •Male partner who is sterile prior to the woman being included in the study and who is the patient’s only sexual partner
- •Levonorgestrel implant
- •Progesterone for injection
- •Oral contraceptives (either combined or progestin only)
- •Any IUD with published data showing a maximum expected failure rate of less than 1% per year
- •Other contraceptive method for which published data show a maximum expected failure rate of less than 1% per year
- •Barrier method if applied in combination with one of the above permissible methods
- •Prior to inclusion in the treatment phase (visit 3), the following criteria must be met in addition:
- •Patients who failed to achieve the status of good control” according to the GOAL criteria during the screening phase (patients who achieved the status of good control” or were not assessable” will discontinue the study after the screening phase).
- •No acute infection of the lower airways between visits 1 and 3.
- •No asthma exacerbation requiring a change in asthma medication between visits 1 and 3.
- •Women of childbearing potential must have a negative (urine) pregnancy test at visit 3.
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient must not be included in this clinical trial if one or several of the following exclusion criteria apply at visit 1:
- •The patient participated in a clinical drug trial within the past 30 days or previously participated in this trial.
- •The patient has a known fluticasone, salmeterol, or salbutamol intolerance.
- •Female patients:
- •the patient is pregnant or breastfeeding,
- •the patient is of childbearing potential (i.e. physically capable of becoming pregnant) and does not use an adequate method of contraception.
- •Treatment with an inhaled steroid within the 4 weeks immediately preceding visit 1 in one of the following dosages: BDP > 500 µg/d, fluticasone > 200 µg/d, budenoside > 400 µg/d, ciclesonide > 200 µg/d, and mometasone > 200 µg/d
研究者
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