Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917643
• Other study ID #: 000202
• Secondary ID: 000202
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: February 2, 2016
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: RWE studies: Not applicable
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2396
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• COPD Exacerbation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	HealthCore, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	COPD respiratory medication use		12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment modification	COPD medication use, such as treatment changes, will be captured post-index.	12 months	No

External Links

•   CSR Synopsis
•   Redacted protocol of Study 000202