Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic Primary Care trial - The TRACkER trial - TRACkER

GPRI0 个研究点目标入组 316 人开始时间: 2019年12月19日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•- Physician diagnosis of COPD (documented obstruction or obstruction measured at the first study visit)
•- Age 40 years and older
•- Symptomatic (defined as Clinical COPD Questionnaire score = 1)
•- ICS-naive (last 12 months no ICS containing treatment)
•- Usage of a long-acting bronchodilator; either usage of a single LABA or LAMA, usage of a single LABA and a single LAMA, or a usage of a single LABA/LAMA inhaler. Patients are allowed to use short-acting bronchodilator.
•- Blood eosinophils =100 cells per µL and one or more characteristics of asthma according to GOLD 2019.
•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 216
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- Chronic oral corticosteroid, use more than 60 days in the last 3 months
•- Recent exacerbation (last 6 weeks before inclusion)
•- Life expectancy of less than 2 years
•- Allergy to intervention formulation
•- Inability to understand Dutch or Greek
•- Any other condition which, at the GPs and/or investigator’s discretion, is believed to present a safety risk or may impact the study results
•- Patients participating in another ongoing clinical trial that in the investigator’s opinion influences the current study (e.g. another randomized controlled trial)
•- Inability to understand and sign the written consent form.

发起方

GPRI