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

niversitair Medisch Centrum Groningen0 个研究点目标入组 260 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•* Age between 40 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.

•* 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.

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