EUCTR2012-005350-39-NL进行中（未招募）不适用
Effects Of extra-fine particle HFA-becLomethasone (HFA-QVAR) Versus course particle treatment In smokers and ex-smokers with Asthma - Effects of QVAR in smokers and ex-smokers with asthma
niversity Medical Centre Groningen0 个研究点开始时间: 2013年4月22日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Males and females with a doctor’s diagnosis of asthma
- •Age between 18 and 65 years
- •Current- and ex-smokers with = 5 packyears.
- •Drop in FEV1 > 20% after provocation with small particle adenosine < 20 mg at visit 1.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •An asthma exacerbation during the last 6 weeks or upper respiration tract infection during the last 4 weeks prior to inclusion in the study.
- •Severe airway obstruction at baseline, FEV1 < 50% of predicted or < 1.2 liter.
- •Physician diagnosed predominant COPD or any other pulmonary disease that could influence the study results as judged by the investigator.
- •Pregnant or lactating women.
- •Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
- •a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
- •b) Hormonal contraception (implantable, patch, oral, injectable).
- •c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- •d) Continuous abstinence.
- •Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
研究者
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