COPD
Conditions
Interventions
In the intervention group patients will use a single inhaler triple therapy
(Trimbow), which includes a combination of beclomethasone dipropionate,
formoterol fumarate dihydrate, and glycopyrronium
Sponsors
GPRI
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the difference in the proportion of patients with a clinically relevant improvement in health status (>=0.4 improvement on the CCQ) between the triple therapy group and LABA/LAMA treatment groups at the end of the 26 weeks intervention period. All main analyses will be conducted intention-to-treat. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, we aim to 1) identify characteristics that predict positive additional response to triple therapy above dual bronchodilator therapy. Effectiveness is defined as improvement in CCQ of >=0.4 from baseline to follow-up.; 2) To compare the number of moderate and severe exacerbations before (6 months) and during the study (6 months) between the study groups; 3) compare the proportion of patients with clinically relevant improvement on either CCQ (>=0.4) or ACQ (>=0.5) between the study groups; 4) To compare the proportion of net responders (positive responders (>=0.4 improvement on the CCQ) minus negative responders ( | — |
Countries
Netherlands
Outcome results
None listed