NL-OMON38937撤回3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
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 visit 1, 2, of 3, i.e. FEV1 < 50% of predicted or < 1.2 liter.;*Maintenance treatment with oral prednisolone.;*Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator*s judgement.;*Ex-smokers who have quit smoking less than 6 months prior to visit 1.;*Pregnant or lactating women. At the first visit 1, a pregnancy test (urine hCG) will be performed in all females.;*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 use 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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