Reduction of corticosteroid use in outpatient treatment ofexacerbated COPD – a randomized, double-blind, non-inferioritystudy (The RECUT”-Trial) - Reduction of corticosteroid use in outpatient treatment of AECOPD - The RECUT”-Trial

Medizinische Universtitätsklinik, Kantonsspital Baselland0 个研究点目标入组 470 人开始时间: 2020年4月28日最近更新: 2020年6月29日

试验速览

暂无简介。

•- Informed Consent as documented by signature
•- Age =40 years
•- History of =10 pack-years of smoking (past or present smokers)
•- Airway obstruction, defined as FEV1/FVC=70%
•- Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the
•o Change of baseline dyspnea
•o Change of cough
•o Change of sputum quantity or purulence
•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 314
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 156

•- Asthma/COPD overlap syndrome with a predominant Asthma component
•- Initial necessity of hospitalization
•- Women who are pregnant or breast feeding
•- Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
•- Severe coexisting disease with life expectancy <6 months
•- Diagnosis of tuberculosis
•- Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
•- Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia,
•etc. of the participant
•- Participation in another study involving an investigational drug
•- Previous enrolment into the current study

发起方

Medizinische Universtitätsklinik, Kantonsspital Baselland