Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

N/ACompletedNCT01917643

AstraZeneca2,396 enrolled

Overview

This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.

Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.

Study Type

OBSERVATIONAL

Enrollment

2,396

Conditions

COPD Exacerbation

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Continuous health plan enrollment for 12 months before and after index Rx * At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim. * COPD diagnosis, and aged 40 years of age at time of first prescription * At risk population for COPD exacerbations Exclusion Criteria: * ICS/LABA combination or LAMA therapy during pre-index period * Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day * Patients diagnosed with cancer * Patients with long-term OCS medication use during pre-index period

Outcomes

Primary Outcomes

Time to first COPD exacerbation

The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.

Time frame: 12 months

Secondary Outcomes

COPD exacerbation rates

The rate of COPD exacerbation will be defined as the total number of COPD exacerbations during the post-index period for all patients in each treatment cohort divided by the total number of person years.

Time frame: 12 months

COPD respiratory medication use

Time frame: 12 months

COPD related utilization

COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay , COPD related ICU admission and length of stay, COPD procedures.

Time frame: 12 months

All-cause utilization

Frequency of all-cause resource use of: inpatient hospitalizations and length of stay, ICU admissions and length of stay, and outpatient/office visits. Total number of different prescription medication classes filled will also be determined.

Time frame: 12 months

All-cause and COPD related healthcare costs

Costs will be reported for the following resource uses: inpatient hospitalizations, ED visits, outpatient/office visits, skilled nursing facility, total medical, and prescriptions. Costs will be reported for all-cause as well as COPD related.

Time frame: 12 months

Data from ClinicalTrials.gov

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