Status:

COMPLETED

Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

HealthCore, Inc.

Conditions:

COPD Exacerbation

Eligibility:

All Genders

40+ years

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 exacer...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2013

Estimated Enrollment :

2396 Patients enrolled

Trial Details

Trial ID

NCT01917643

Start Date

August 1 2013

End Date

November 1 2013

Last Update

February 3 2016

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