TRACkER trial
Key facts
- Where
- Groningen, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- General Practitioners Research Institute B.V.Groningen, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- General Practitioners Research Institute B.V.
- Trial code
- EU 2023-508300-37-00
- Record updated
- 2023. október 24.
- Original description
To investigate the effectiveness of triple therapy (ICS/LABA/LAMA) on the change in health status, measured with the Clinical COPD Questionnaire (CCQ), in symptomatic ICS-naive COPD patients with characteristics of asthma according to GOLD 2019 and blood eosinophil counts of ≥100 cells per μL compared to treatment with dual therapy (LABA/LAMA), within a primary care population.Read full original descriptionShow less
Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial
To investigate the effectiveness of triple therapy (ICS/LABA/LAMA) on the change in health status, measured with the Clinical COPD Questionnaire (CCQ), in symptomatic ICS-naive COPD patients with characteristics of asthma according to GOLD 2019 and blood eosinophil counts of ≥100 cells per μL compared to treatment with dual therapy (LABA/LAMA), within a primary care population.
Inclusion: 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.
Exclusion: Recent exacerbation (last 6 weeks before inclusion); Chronic oral corticosteroid, use more than 60 days in the last 3 months, except for prescriptions during a Covid infection; Allergy to intervention formulation; 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; Life expectancy of less than 2 years; Inability to understand national language; 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.