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Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

COPD Exacerbation

Study type

Observational

Funder types

Industry

Identifiers

NCT01917643
000202 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,396 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,396 participants in 2 patient groups

Symbicort
Description:
BFC patients new to ICS/LABA and LAMA therapies
Spiriva
Description:
Tiotropium bromide patients new to ICS/LABA and LAMA therapies

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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