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: 2013年8月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

niversity Medical Centre Groningen