CANIS (SIRIUS-CAN): Canadian Adults with COPD on INhaled Triple Therapy with Exacerbations A Study on Epidemiology, Patient Characteristics, Management, Outcomes, and Healthcare Resource Utilization in Ontario

Summary

Client: Broadstreet Health Economics and Outcomes Research

Project ID: P2024-229/ 2026 0980 014 000

Research Question/Objectives: Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that affects over two million adults in Canada. COPD exacerbations occur when symptoms become severe and may require antibiotics, oral corticosteroids (OCS), and even emergency department visits and/or hospitalization.

Use of triple therapy has been associated with fewer exacerbations and reduced mortality, healthcare utilization and costs. Despite this, some COPD patients continue to experience moderate to severe exacerbations while receiving triple inhaled maintenance therapy, highlighting a need for the development of new therapies to prevent exacerbations and subsequent loss in lung function and mortality.

Objectives: 

Primary Objective

1. To describe the prevalence of COPD patients (≥65 years) in Ontario who experience at least 2 moderate exacerbation within 12 months or 1 severe COPD exacerbation while using inhaled triple maintenance therapy. These patients would be considered potentially eligible for a biologic therapy.

Secondary Objectives

1. To describe COPD exacerbation rates in COPD patients who received inhaled triple maintenance therapy.
2. To describe baseline clinical and demographic characteristics of COPD patients on inhaled triple maintenance therapy during ‘biologic eligible’ and ‘biologic ineligible’ periods.
3. To describe the incidence of additional clinical outcomes and time to mortality among ‘biologic eligible’ and ‘biologic ineligible’ periods among COPD patients on inhaled triple maintenance therapy.
4. To describe treatment patterns during ‘biologic eligible’ and ‘biologic ineligible’ periods among COPD patients on inhaled triple maintenance therapy.
5. To assess HCRU and costs of care during ‘biologic eligible’ and ‘biologic ineligible’ periods among COPD patients on inhaled triple maintenance therapy.
6. To explore baseline demographics and clinical characteristics associated with biologic eligibility at 12-months following triple therapy initiation.
7. To assess absolute and relative rates of clinical outcomes, add-on treatments, HCRU, and costs among ‘biologic eligible’ compared to ‘biologic ineligible’ periods among COPD patients on inhaled triple maintenance therapy.

Exploratory Objective

1. To explore regional variability in prevalence of COPD patients who experienced ≥2 moderate COPD exacerbations within 12 months or ≥1 severe COPD exacerbation while on triple inhaled maintenance therapy

Status: In progress