Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000325

EU PAS number

EUPAS1000000325

Study ID

1000000325

Official title and acronym

Long-Acting Inhalable Drugs for Chronic Obstructive Pulmonary Disease

DARWIN EU® study

No

Study countries

Canada

Study description

Chronic obstructive pulmonary disease (COPD) affects millions of Canadians and adults around the world. Acute events in COPD, called exacerbations, are associated with significant morbidity, mortality, and health care expenditures. While these acute exacerbations can be treated with short-acting inhalers, oral corticosteroids, and antibiotics, daily use of maintenance inhalers can help reduce their frequency and severity. The 3 general categories of maintenance inhalers include long-acting β2 agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICS). Historically, guidelines have recommended a step-wise approach in which patients experiencing mild to moderate COPD should start with maintenance therapy with LABA or LAMA alone and, should that therapy be inadequate, add on additional inhaled therapies (up to LABA/LAMA/ICS triple therapy). However, evidence-based guidelines now recommend starting patients with moderate to severe COPD and a low exacerbation risk on LABA/LAMA combination therapy and those at high risk of exacerbation on ICS/LABA/LAMA combination therapy, though most drug plan programs currently require patients to fail monotherapy before reimbursing combination therapy.
It is necessary to conduct a utilization study describing how long-acting inhaled COPD maintenance therapies have been (and continue to be) prescribed across Canada. We will first identify patients’ initial long-acting inhaled COPD therapies (LABA, LAMA, LABA/LAMA, LABA/ICS, LAMA/ICS, and LABA/LAMA/ICS) and describe their characteristics and how use of each type of initial therapy has changed over calendar time. We will then track how patients’ therapy choice changes, track how patients’ step-up or step-down, when they discontinue therapy, and the frequency of exacerbations over the course of patients’ first 4 “lines” of treatment. We will also describe differences between these treatment trajectories between 2012-2017 and 2018-2024

Study status

Ongoing
Research institutions and networks

Institutions

University of Calgary, Calgary, Canada
University of Manitoba, Winnipeg, Canada
Dalhousie University, Halifax, Canada
ICES, Toronto, Canada
Saskatchewan Health Quality Council, Saskatoon, Canada

Networks

Canadian Network for Observational Drug Effect Studies (CNODES)

Contact details

Michael Webster-Clark

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

CNODES is a collaborating core network partner of CoLab, which is funded for query-related activity by Canada’s Drug Agency (CDA, grant number C222 360).
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable