Comparative Effectiveness of COPD Treatments

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.

Official Title
-----------------
Comparative Effectiveness of Combination Therapies in COPD

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: LABA and the LAMA tiotropium (LABA-TIO)
* Drug: LABA and an ICS (LABA-ICS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015 Diagnosis of COPD and age ≥ 55 years Exclusion Criteria: Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry) Asthma diagnosis

Ages Eligible for Study
-----------------
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects diagnosed with COPD<br>Chronic obstructive pulmonary disease | Drug: LABA and the LAMA tiotropium (LABA-TIO)<br>* combinational drug<br>* Other names: FORVENT, SPIRIVA, SRIVASSO;Drug: LABA and an ICS (LABA-ICS)<br>* combinational drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry | The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis. | 12 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of COPD Exacerbations | Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated. | 12 years | 
| The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments. | 12 years |