Comparative effectiveness of combination therapies in COPD

Study type
Protocol
Date of Approval
Study reference ID
17_159
Lay Summary

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by increasing breathlessness. It is a major cause of disability, it reduces quality of life and is one of the leading causes of death. An acute exacerbation of COPD can occur when there is a sudden worsening of usual COPD symptoms such as increase in wheezing and shortness of breath, as well as presence of persistent cough. Severe exacerbations require hospitalisation. Several treatments can be prescribed to improve COPD symptoms. Typically, it involves medication called bronchodilators. This class of drug helps to reduce shortness of breath by opening up the airways and makes it easier to breath. However, the relief of symptoms often involves the addition of different type of medicines such as the combination of a long acting bronchodilator with either an inhaled corticosteroid or with tiotropium. The objective of the study is to compare the effectiveness of these two different combinations to help prevent the occurrence and the frequency of COPD exacerbation as well as to compare their safety with respect to pneumonia.

Technical Summary

The objective of this study is to assess the effectiveness and safety of maintenance treatment of chronic obstructive pulmonary disease (COPD) with the combination of long-acting beta2-agonist with tiotropium (LABA-TIO) compared to the combination with inhaled corticosteroid (LABA-ICS). We will conduct a matched cohort study among patients with COPD to assess the effect of the LABA-TIO combination compared with the LABA-ICS combination on the time to a COPD exacerbation or the risk of pneumonia. Each patient using for the first time the LABA-TIO combination (without ICS) will be matched to one first time user of the LABA-ICS combination based on propensity score, sex, previous components of the study treatment (LABA only, TIO only, ICS alone, none of these) and the presence of an acute COPD exacerbation in the year before cohort entry. After matching, subjects in the cohort will be followed for up to one year or until the occurrence of the outcome. The time-dependent Cox proportional hazard model will be use to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.

Health Outcomes to be Measured

COPD exacerbation; Community acquired pneumonia.

Collaborators

Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill University

Linkages

HES Admitted Patient Care