Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial - GPRI-19102-TRA

General Practitioners Research Institute B.V.0 个研究点目标入组 316 人开始时间: 2023年9月21日最近更新: 2024年7月22日

试验速览

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•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 a short-acting bronchodilator., Blood eosinophils =100 cells per µL AND one or more characteristics of asthma according to GOLD 2019.

•Chronic oral corticosteroid, use more than 60 days in the last 3 months, except for prescriptions during a Covid infection, Recent exacerbation (last 6 weeks before inclusion), Life expectancy of less than 2 years, Allergy to intervention formulation, Inability to understand national language., Any other condition which, at the physician’s 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

General Practitioners Research Institute B.V.