2023-508300-37-00CompletedPhase 4
TRACkER trial
Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Oct 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 316 (actual)
- First submitted
- 21 Sept 2023
- Start date
- 1 Feb 2020
- Lead sponsor
- General Practitioners Research Institute B.V.
- Diseases
- COPD
- EU CT number
- 2023-508300-37-00
- EudraCT number
- 2019-003351-11
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 316
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent exacerbation (last 6 weeks before inclusion)
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Practitioners Research Institute B.V. | Groningen | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.