Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(R03AL11) formoterol, glycopyrronium bromide and budesonide
formoterol, glycopyrronium bromide and budesonide

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)

Estimated number of subjects

750
Study design details

Main study objective

To describe the acceptability and clinical outcomes of Breztri/Trixeo amongst patients with COPD.

Outcomes

The primary outcome will be medication success assessed at 90 days (early medication success) after Breztri/Trixeo initiation, which will be as no major cardiac and respiratory events (MACRE) and no pneumonia, 1. patient demographic and clinical characteristics at initiation, 2. changes in CAT score, 3. factors associated with the primary outcome CAT change at 90 days, 4. medication success assessed at 180 days, 5. short-acting beta-agonist use, 6. acceptability of medication change, 7. adherence, 8. overall number of inhalers used, 9. change in COPD control and in exercise capacity at 90 days

Data analysis plan

Primary and exploratory outcomes will be summarised as means, medians or percentages as appropriate with 95% confidence intervals. For the primary outcome, medication success will be claimed if the lower 95% confidence limit for the percentage achieving success is ≥ 70%, assessed at 90 days after Breztri/Trixeo initiation. Exploratory outcomes will be summarised separately for 90 days and 180 days. Additionally, an exploratory analysis will be carried out to try to identify factors associated with the primary outcome (early medication success) and with change in CAT score at 90 days.
Documents
Study results

Trixeo Report v3.2

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