Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

Completed

• Conditions: COPD Exacerbation

• Registration Number: NCT01917643
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-07-31
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2396

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first COPD exacerbation	12 months	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.

Secondary Outcome Measures

Name	Time	Method
COPD exacerbation rates	12 months	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.
COPD respiratory medication use	12 months
COPD related utilization	12 months	COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay , COPD related ICU admission and length of stay, COPD procedures.
All-cause utilization	12 months	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.
All-cause and COPD related healthcare costs	12 months	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.
Treatment patterns and adherence	12 months	Continuity of care during the 12 month post-index period will be measured with the Bice and Boxerman index. Proportion of Days Covered (PDC) and Medication Possession Ration (MPR) will be used to measure the compliance of index medication (Symbicort or Spiriva) during the 12 month post-index period.
Treatment modification	12 months	COPD medication use, such as treatment changes, will be captured post-index.