We will use administrative health databases from the provinces on Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, and Saskatchewan.
In each province, we will identify a base cohort of adults aged ≥ 40 years (or ≥ 67 in Ontario and in Nova Scotia for era 1) who initiated treatment with 1 of the 6 long-acting inhalable drugs (defined above) between January 1, 2012 and March 31, 2024 (or the latest available date of data at the site), with ≥ 1 hospitalization with a diagnostic code for COPD or ≥ 1 medical service claim with a COPD diagnostic code within the 730 days prior to and 14 days after treatment initiation.
The date of treatment initiation will define base cohort entry.
We will exclude patients with less than 730 days of observation time in the database prior to the start of treatment and those with recorded use of any long-acting inhalable COPD treatment in the 730 days prior.
The resulting population will then be split into 2 distinct eras: individuals whose first dispensing date range from January 1, 2012 and December 31, 2017; and from January 1, 2018 and March 31, 2024.
From this base cohort, the study cohort will be assigned to 6 treatment groups based on the therapy initiated: LABA monotherapy, LAMA monotherapy, LABA/LAMA, LABA/ICS, LAMA/ICS, and LABA/LAMA/ICS combination therapies.
Individuals who fill prescriptions for multiple types of inhalers within 14 days of the first inhaler will be classified as users of the combination therapy. If patients appear to be initiating ICS monotherapy, they will be excluded due to highly likely exposure misclassification.
Study outcomes will be assessed within 2 time periods on either side of cohort entry: 1) in the 365 days prior for the initiation treatment; and after for the post-initiation treatment trajectories. The end of follow-up for the post-initiation outcomes will be defined as the earliest of the following dates: the date of death from any cause, end of coverage, or end of the study period