Effectiveness of Triple Therapy in COPD

Study Overview
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Brief Summary
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To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.

Official Title
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Comparative Effectiveness of Triple Therapy in COPD: A New-user Cohort Study

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)
* Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016. Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler. Exclusion Criteria: Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry) Asthma diagnosis prior to study cohort entry

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Chronic obstructive pulmonary disease (COPD)<br> | Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)<br>* (LABA-LAMA-ICS)<br>Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)<br>* (LABA-LAMA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Hospitalised With Severe Exacerbation | The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented. | 1 year | 
| Number of Participants Hospitalised With Moderate Exacerbation | The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) is presented. | 1 year | 
| Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia) | The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of COPD Exacerbations Over the One-year Follow-up | This outcome was based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid. A gap of at least 30 days between treatment courses was required to consider the exacerbations as separate events. | 1 year |