Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation

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 Type: Observational
• Enrollment (Actual): 2396

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or tiotropium bromide during 3/1/2009 and 1/31/2012 who are naive to ICS/LABA and LAMA combination therapies.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Symbicort; BFC patients new to ICS/LABA and LAMA therapies
Spiriva; Tiotropium bromide patients new to ICS/LABA and LAMA therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Treatment modification	COPD medication use, such as treatment changes, will be captured post-index.	12 months
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.	12 months
COPD respiratory medication use		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.	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.	12 months
Treatment patterns and adherence	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.	12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: HealthCore, Inc.

Publications and helpful links

Helpful Links

• Redacted protocol of Study 000202
• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (ESTIMATE): August 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: COPD, Comparative Effectiveness, Symbicort
• Other Study ID Numbers: 000202 (Astrazeneca)