Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD - SMART versus fixed dose treatment in COPD

niversity Medical Center Groningen0 个研究点开始时间: 2015年2月3日最近更新: 2015年2月23日

适应症

试验速览

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•Age between 18 and 80 years
•Smoking history of > 10 pack years
•COPD patients with an FEV1 < 80% predicted either or not using inhaled corticosteroids.
•At least one COPD exacerbation for which oral prednisolone had to be prescribed during 2 years prior to inclusion in the study.
•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 260
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 260

•History of asthma.
•Exacerbation or respiratory tract infection during the last 4 weeks prior to randomization.
•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 >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